Back to resultsInvestigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults (CLoNE)
Primary Purpose
Hypercholesterolemia
Status
Completed
Phase
Not Applicable
Locations
Australia
Study Type
Interventional
Intervention
Swisse Nutra+ Cholesterol Balance
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Hypercholesterolemia focused on measuring hypercholesterolemia, low-density lipoprotein, nutraceutical, bergamot, artichoke, phytosterols, hydroxytyrosol
Eligibility Criteria
Inclusion Criteria:
- Male or female aged 18-65 inclusive
- Fasting LDL-cholesterol ≥2.5mmol/L and ≤5mmol/L* confirmed at screening visit
- Low cardiovascular disease (CVD) risk score (for individuals aged 45-65 years, inclusive) determined using Framingham Risk Equation <10% absolute risk of CVD events over 5 years# as determined using a risk calculator (1) or in the event that this is not available using Australian cardiovascular risk charts (2)
- Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2 confirmed during screening period and Day 1
- Willing to provide written Informed Consent
Exclusion Criteria:
- Serum LDL-cholesterol >5 mmol/L* at screening
- Use of omega-3 supplements at high dose (>900 mg/day of docosahexaenoic acid (DHA) / eicosapentaenoic acid (EPA))
- Use of and not prepared to abstain from lipid lowering medications, supplements or fortified foods containing substances that may, in the opinion of the medical investigator, affect lipid concentrations (e.g. statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid, or omega-3 supplements <900 mg/day DHA/EPA) , soluble fibre, e.g. β-glucan/psyllium, plant sterols, curcumin/turmeric) within past 28 days of Day 1
- Previous diagnosis of chronic disease such as CVD, diabetes, cancer, familial hypercholesterolaemia, kidney disease
- Smoking (i.e. history of smoking within the last six months)
- Serum triglycerides >4.5mmol/L (LDL-cholesterol concentrations are unreliable in the presence of high triglyceride levels)
Women of childbearing potential (WOCBP) who:
- Are not currently using effective methods of contraception and
- Have not been using effective methods of contraception for 14 days prior to day 1 and
- Are not willing to use effective methods of contraception throughout the study
- WOCBP who have a positive urine dipstick pregnancy test at screening or Day 1, or currently pregnant or lactating
- Untreated hypertension (blood pressure ≥140/90mmHg)
- Aversion and/or intolerance/allergy to the study intervention products ^
- Unwilling or unable to maintain usual levels of physical activity for the duration of the study
- History of or known presence of alcohol abuse or illicit drug use, any surgical history, clinically significant conditions (i.e. renal, or urological disease, liver disease gastrointestinal disease or any other significant disease) or organ dysfunction that in the opinion of the investigator may affect the participant's ability to participate in the study or the study results
- Currently hospitalised or any planned hospitalisations during the study or up to one month following the last dose of the study product that may affect the participant's ability to comply with the study in the opinion of the Medical Investigator
- Received an investigational drug within 3 months prior to Day 1 that in the opinion of the investigator may affect the applicant's ability to participate in the study or the study results
Sites / Locations
- CSIRO Nutrition and Health Research Clinic
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Active Group
Placebo
Arm Description
Active treatment comprises of 3 soft gel capsules daily (with food) of Swisse Nutra+ Cholesterol Balance, a novel combination nutraceutical containing bergamot juice extract, artichoke leaf extract, hydroxytyrosol and plant sterols, totaling a daily dose of 375 mg bergamot juice extract, 150 mg artichoke leaf extract, 50 mg hydroxytyrosol and 1.8 g sunflower phytosterols. Each capsule contains 125mg of bergamot juice extract, 50mg artichoke leaf extract, 16.67mg hydroxytyrosol and 600mg plant sterols. The intervention will be administered for 4 months (112 days).
3 soft gel capsules of matching placebo daily (total daily dose of 696 mg palm olein and 232 mg olive oil).
Outcomes
Primary Outcome Measures
Change in LDL-cholesterol
Low-density lipoprotein-cholesterol (LDL-C) will be analysed using standardised methods. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of serum LDL-cholesterol.
Change in serum LDL-C (mmol/L) from baseline will be recorded.
Secondary Outcome Measures
Serum lipid concentrations from baseline
Change in serum lipid concentrations of the following measures (total cholesterol, high-density lipoprotein-cholesterol, triglycerides, non-HDL-C, total cholesterol:HDL-cholesterol ratio, apolipoproteinA1 (apoA1), apolipoproteinB (apoB), apoB:apoA1 ratio) will be analysed. Fasting blood samples (total of ~14 ml) will be collected into vacutainers containing a clot activator for the preparation of serum.
Secondary blood-based outcomes will be analysed using standardised methods. Immunoturbidimetric test kits will be used for analysis of apoA1 and apoB. Total cholesterol:HDL-cholesterol and apoB:apoA1 ratio will be calculated from the results. Non-HDL-cholesterol will be calculated as total cholesterol - HDL-cholesterol.
Blood pressure changes from baseline
Resting systolic and diastolic blood pressure (mmHg) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.
Changes in HbA1c from baseline
Whole Ethylenediaminetetraacetic acid (EDTA) blood samples will be collected to analyse haemoglobin A1C (HbA1c) concentration changes during the study period. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of HbA1c.
Changes in plasma ox-LDL
Changes in plasma oxidised-low-density lipoprotein will be analysed by commercial ELISA kit. Vacutainers containing K2-EDTA anticoagulant will be used for the preparation of plasma. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Changes in serum malondialdehyde
Changes in serum malondialdehyde will be analysed by commercial colorimetric assay kit. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Changes to diet
Participant's habitual dietary intake will be assessed at Baseline and 4 month visits using the Automated Self-Administered 24-hour (ASA24-Australia) Dietary Assessment Tool, version (2016), developed and validated by the National Cancer Institute, Bethesda, MD (36). Three 24-hour recalls will be completed at each occasion. At Day 1, participants will complete the first 24-hour recall during a dietitian consultation while the subsequent 24-hour recalls will be completed by the participant at home within 7-days of Day 1 and on days as specified by the dietitian (including 2 week- and 1 weekend day). Overall, all days of the week will be covered by participants. Nutrient analysis is automated through the ASA24 program and uses the Australian Food, Supplement and Nutrient Database (AUSNUT, 2011-13).
Changes in anthropometric measurements - height
Height will be measured at Screening (cm). Height will be measured using a stadiometer.
Waist and hip circumference (cm) will be measured at Baseline, 2- and 4 month or Early Withdrawal visits. Waist will be measured at the top of the iliac crest with a plastic measuring tape and taken at minimal respiration for the average of three consecutive readings. Hip circumference will be measured at the largest circumference of the buttocks.
Changes in anthropometric measurements - weight
Body weight (kg) will be measured at screening and Day 1 and also be collected at the 2 month, 4 month or Early Withdrawal visits. Body weight will be measured using calibrated electronic digital scales.
Changes in anthropometric measurements - BMI
Body mass index (BMI) will be calculated using the formula weight (kg)/height (m)2. BMI will be assessed at screening, baseline, 2 months, and 4 months.
Changes in anthropometric measurements- WHR
Waist:hip ratio (WHR) will be calculated using the formula waist circumference (cm)/hip circumference (cm). WHR will be calculated from measurements taken at Baseline, 2 and-4 months or Early Withdrawal visits.
Changes in body composition
Fat mass and fat free mass will be measured at Baseline, 2- and 4 month or Early Withdrawal visits using a multi-frequency bioelectrical impedance analysis machine with 8 tactile electrodes (InBody 770, Biospace Co. Ltd, Seoul). Measurements will be obtained after voiding. Participants will stand upright, positioning their bare feet on the footpads and their hands on the handles. A small electrical current is passed through the body, resistance is measured, and total body water and the corresponding body composition measures are calculated by the inbuilt software.
Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
All adverse events will be recorded from dosing until the end of the study (Final Safety Visit or early withdrawal). At clinic visit at month 2 and month 4 and online surveys, participants will be questioned in a non-leading manner regarding the occurrence of any adverse medical event. All AEs will be documented in the source documents and evaluated by the Medical Investigator for severity and causality to study treatment. All SAEs will be reported to the study sponsor as per standard Good Clinical Practice (GCP) requirements.
Safety- Number of participants with significant changes to blood pressure over study period between groups
Vital signs will be measured by a designee while the participant is seated. Resting blood pressure (systolic/diastolic mmHG) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Safety - Number of participants who fall pregnant (WOCBP only)
A urine sample will be collected at Screening, Baseline, 2 and 4 month Visit or Early Withdrawal visit in WOCBP only. Study staff will perform a dipstick urine pregnancy test and record the result in the source documents.
Safety - Number of participants with significant changes to heart rate between groups
Vital signs will be measured by a designee while the participant is seated. Heart rate will be measured as beats/minute by palpating the participants' carotid and radial pulses. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Number of participants with changes to heart sounds
The Medical Investigator will perform a non-invasive physical examination of the participants' cardiovascular system by listening to heart sounds to determine whether there is a heart murmur or irregular heart beat.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety - Number of participants with significant changes to respiratory rate between groups
Respiratory rate will be measured by counting the number of times the chest rises per minute while the participant is at rest. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Number of participants with changes to respiratory effort
The Medical Investigator will perform a non-invasive physical examination of the participants' lung function by observing the participants' breathing rhythm and chest movement.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety - Number of participants with significant changes to core body temperature between groups
Vital signs will be measured by a designee while the participant is seated. Body temperature (°C) will be measured using a digital thermometer.
Safety: Number of participants with macroscopic abnormalities of the eyes
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of the appearance of the pupil, iris, cornea, eyelids, eyelashes, conjuctiva and periorbital are including redness, discharge, lesions, ulcers, abrasions or unusual growths.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety -Number of participants with visual symptoms
Participants will be asked to self-report on any visual symptoms or changes e.g. blurriness, eye strain etc. throughout the study period.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
A non-invasive physical examination will be performed by a Medical Investigator and will include
A visual assessment of the ears, nose, mouth and throat to check for signs of infection
Palpation of the cervical chain lymph nodes to check for signs of infection
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with changes to peripheral vascular function
A non-invasive physical examination will be performed by a Medical Investigator and will include palpating the dorsal pedis pulse, posterior tibial pulse and palpation of the ankles to check for peripheral oedema.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with respiratory disease
The Medical Investigator will perform a non-invasive physical examination of the participants' respiratory system by listening to breath sounds to determine whether there is untreated asthma or other lung disease.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with changes to the gastrointestinal tract
Medical Investigator will perform a non-invasive physical exam by observing and palpating the participants' abdomen to check for surgical scars, ascites, organomegaly and abdominal discomfort.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Changes to characteristics in physical examination - musculoskeletal
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of joint mobility. Participants will be asked to to stand and sit back down into a chair unassisted, to reach forward and try to touch their toes, and to touch their opposite shoulder blades across their front, behind their neck and behind their back (Apley Shoulder test).
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with changes to characteristics in skin appearance
A non-invasive physical examination will be performed by a Medical Investigator who will observe the participants' skin colour, looking for central and peripheral cyanosis, jaundice, or any skin rashes or lesions.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Safety: Number of participants with clinically significant changes in biochemistry - AST
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Aspartate aminotransferase (AST) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry- ALT
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alanine aminotransferase (ALT) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - GGT
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in gamma glutamyltransferase from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - ALP
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alkaline phosphatase (ALP) (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - LD
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Lactate Dehydrogenase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - creatinine
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine (µmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine kinase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in urea nitrogen (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - sodium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood sodium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - potassium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood potassium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - chloride
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood chloride levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood bicarbonate levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - urea
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood urea levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - calcium
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in calcium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - CRP
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in C-reactive protein levels (CRP) measured as mg/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - uric acid
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in uric acid measured as mol/mol will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - phosphate
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in phosphate (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - albumin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in albumin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - globulins
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in globulins (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - protein
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in protein (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in total bilirubin (umol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in biochemistry - glucose
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in fasting glucose (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - RDW
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red cell distribution (RDW) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - haemoglobin
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in haemoglobin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - RBC
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red blood cell count (RBC) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - PCV
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in packed cell volume (PCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - MCV
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell volume (MCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - MCHC
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell hemoglobin concentrations (MCHC) measured as g/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - platelets
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of platelets will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of white cells will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - neutrophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of neutrophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - lymphocytes
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of lymphocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - monocytes
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of monocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - eosinophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of eosinophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Safety: Number of participants with clinically significant changes in haematology - basophils
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of basophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Full Information
NCT ID
NCT04783714
First Posted
February 11, 2021
Last Updated
March 9, 2022
Sponsor
Swisse Wellness Pty Ltd
Collaborators
Commonwealth Scientific & Industrial Research Organisation, BIONAP SRL
1. Study Identification
Unique Protocol Identification Number
NCT04783714
Brief Title
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
Acronym
CLoNE
Official Title
Investigating the Effects of a Novel Nutraceutical Combination (Swisse Nutra+ Cholesterol Balance) on Low-density Lipoprotein Cholesterol and Other Markers of Cardiometabolic Health in Australian Adults With Hypercholesterolaemia: A Randomised, Double-blind, Placebo Controlled Trial
Study Type
Interventional
2. Study Status
Record Verification Date
April 2021
Overall Recruitment Status
Completed
Study Start Date
April 30, 2021 (Actual)
Primary Completion Date
October 22, 2021 (Actual)
Study Completion Date
October 22, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Swisse Wellness Pty Ltd
Collaborators
Commonwealth Scientific & Industrial Research Organisation, BIONAP SRL
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
To evaluate the effects of daily consumption of 3 capsules of Swisse Nutra+ Cholesterol Balance on serum LDL-cholesterol in adults with hypercholesterolaemia compared to placebo over four months.
This is a single-centre, randomised, double-blind, placebo controlled, parallel study.
Applicants will be eligible to participate if they have hypercholesterolemia, defined by fasting LDL-cholesterol 2.5mmol/L and ≤5 mmol/L confirmed at screening visit. Participants who are otherwise healthy will be included in the study; individuals with a history of cardiovascular disease are excluded from this trial.
Following pre-screening telephone assessment, applicants will attend an in-clinic screening visit and following informed consent, their general health and eligibility for inclusion into the study will be assessed.
On Day 1 eligible participants will be randomly allocated to receive one of two study treatments (intervention or placebo). Participants will consume the assigned treatment daily for four months.
Participants will return to the clinic at months 2 and 4 for assessment of primary and secondary outcomes. Compliance, adverse events and concomitant medication use will be assessed at these visits. In addition, participants will complete an online survey at months 1 and 3 to assess protocol compliance, adverse events and use of concomitant medications. Any queries that arise from the survey will be followed up by phone call.
Dietary intakes will be assessed at the baseline and four-month visits. A final participant online survey and phone call (if needed) will be conducted one month after the 4-month visit for a final safety assessment.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hypercholesterolemia
Keywords
hypercholesterolemia, low-density lipoprotein, nutraceutical, bergamot, artichoke, phytosterols, hydroxytyrosol
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
Treatment arm and Placebo arm
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Masking Description
Double-blind
Allocation
Randomized
Enrollment
42 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Active Group
Arm Type
Experimental
Arm Description
Active treatment comprises of 3 soft gel capsules daily (with food) of Swisse Nutra+ Cholesterol Balance, a novel combination nutraceutical containing bergamot juice extract, artichoke leaf extract, hydroxytyrosol and plant sterols, totaling a daily dose of 375 mg bergamot juice extract, 150 mg artichoke leaf extract, 50 mg hydroxytyrosol and 1.8 g sunflower phytosterols.
Each capsule contains 125mg of bergamot juice extract, 50mg artichoke leaf extract, 16.67mg hydroxytyrosol and 600mg plant sterols.
The intervention will be administered for 4 months (112 days).
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
3 soft gel capsules of matching placebo daily (total daily dose of 696 mg palm olein and 232 mg olive oil).
Intervention Type
Dietary Supplement
Intervention Name(s)
Swisse Nutra+ Cholesterol Balance
Intervention Description
Swisse Nutra+ Cholesterol Balance is a multi-ingredient nutraceutical composition contained in a brown soft-gel capsule format. Three capsules are required per dose.Swisse Nutra+ Cholesterol Balance is a multi-ingredient formulation containing artichoke extract, bergamot juice extract, hydroxytyrosol, an antioxidant derived from olive oil and sunflower oil-derived phytosterols. All ingredients target cholesterol reduction by different and complementing mechanisms, as evidenced by human clinical trials. These ingredients have been chosen to work synergistically to alleviate hypercholesterolemia and/or dyslipidemia through multiple pathways, whereby each ingredient works via a different mechanism to lower LDL-cholesterol in the body.
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Matched brown soft-gel capsule placebo containing olive oil and palm olein - no therapeutic benefit.
Primary Outcome Measure Information:
Title
Change in LDL-cholesterol
Description
Low-density lipoprotein-cholesterol (LDL-C) will be analysed using standardised methods. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of serum LDL-cholesterol.
Change in serum LDL-C (mmol/L) from baseline will be recorded.
Time Frame
From baseline to 4 months
Secondary Outcome Measure Information:
Title
Serum lipid concentrations from baseline
Description
Change in serum lipid concentrations of the following measures (total cholesterol, high-density lipoprotein-cholesterol, triglycerides, non-HDL-C, total cholesterol:HDL-cholesterol ratio, apolipoproteinA1 (apoA1), apolipoproteinB (apoB), apoB:apoA1 ratio) will be analysed. Fasting blood samples (total of ~14 ml) will be collected into vacutainers containing a clot activator for the preparation of serum.
Secondary blood-based outcomes will be analysed using standardised methods. Immunoturbidimetric test kits will be used for analysis of apoA1 and apoB. Total cholesterol:HDL-cholesterol and apoB:apoA1 ratio will be calculated from the results. Non-HDL-cholesterol will be calculated as total cholesterol - HDL-cholesterol.
Time Frame
From baseline to 4 months
Title
Blood pressure changes from baseline
Description
Resting systolic and diastolic blood pressure (mmHg) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.
Time Frame
From baseline to 4 months
Title
Changes in HbA1c from baseline
Description
Whole Ethylenediaminetetraacetic acid (EDTA) blood samples will be collected to analyse haemoglobin A1C (HbA1c) concentration changes during the study period. A Beckman AU480 clinical analyser (Beckman Coulter Inc, Brea, CA, USA) and relevant commercial enzymatic test kits will be used for analysis of HbA1c.
Time Frame
From baseline to 4 months
Title
Changes in plasma ox-LDL
Description
Changes in plasma oxidised-low-density lipoprotein will be analysed by commercial ELISA kit. Vacutainers containing K2-EDTA anticoagulant will be used for the preparation of plasma. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Time Frame
From baseline to 4 months
Title
Changes in serum malondialdehyde
Description
Changes in serum malondialdehyde will be analysed by commercial colorimetric assay kit. This assay will be measured on an EnVision Multilabel plate reader (Perkin Elmer, MA, USA).
Time Frame
From baseline to 4 months
Title
Changes to diet
Description
Participant's habitual dietary intake will be assessed at Baseline and 4 month visits using the Automated Self-Administered 24-hour (ASA24-Australia) Dietary Assessment Tool, version (2016), developed and validated by the National Cancer Institute, Bethesda, MD (36). Three 24-hour recalls will be completed at each occasion. At Day 1, participants will complete the first 24-hour recall during a dietitian consultation while the subsequent 24-hour recalls will be completed by the participant at home within 7-days of Day 1 and on days as specified by the dietitian (including 2 week- and 1 weekend day). Overall, all days of the week will be covered by participants. Nutrient analysis is automated through the ASA24 program and uses the Australian Food, Supplement and Nutrient Database (AUSNUT, 2011-13).
Time Frame
From baseline to 4 months
Title
Changes in anthropometric measurements - height
Description
Height will be measured at Screening (cm). Height will be measured using a stadiometer.
Waist and hip circumference (cm) will be measured at Baseline, 2- and 4 month or Early Withdrawal visits. Waist will be measured at the top of the iliac crest with a plastic measuring tape and taken at minimal respiration for the average of three consecutive readings. Hip circumference will be measured at the largest circumference of the buttocks.
Time Frame
From baseline to 4 months
Title
Changes in anthropometric measurements - weight
Description
Body weight (kg) will be measured at screening and Day 1 and also be collected at the 2 month, 4 month or Early Withdrawal visits. Body weight will be measured using calibrated electronic digital scales.
Time Frame
Baseline to 4 months
Title
Changes in anthropometric measurements - BMI
Description
Body mass index (BMI) will be calculated using the formula weight (kg)/height (m)2. BMI will be assessed at screening, baseline, 2 months, and 4 months.
Time Frame
Baseline to 4 months.
Title
Changes in anthropometric measurements- WHR
Description
Waist:hip ratio (WHR) will be calculated using the formula waist circumference (cm)/hip circumference (cm). WHR will be calculated from measurements taken at Baseline, 2 and-4 months or Early Withdrawal visits.
Time Frame
Baseline to 4 months
Title
Changes in body composition
Description
Fat mass and fat free mass will be measured at Baseline, 2- and 4 month or Early Withdrawal visits using a multi-frequency bioelectrical impedance analysis machine with 8 tactile electrodes (InBody 770, Biospace Co. Ltd, Seoul). Measurements will be obtained after voiding. Participants will stand upright, positioning their bare feet on the footpads and their hands on the handles. A small electrical current is passed through the body, resistance is measured, and total body water and the corresponding body composition measures are calculated by the inbuilt software.
Time Frame
From baseline to 4 months
Title
Safety - Incidence of adverse events (AEs) and serious adverse events (SAEs)
Description
All adverse events will be recorded from dosing until the end of the study (Final Safety Visit or early withdrawal). At clinic visit at month 2 and month 4 and online surveys, participants will be questioned in a non-leading manner regarding the occurrence of any adverse medical event. All AEs will be documented in the source documents and evaluated by the Medical Investigator for severity and causality to study treatment. All SAEs will be reported to the study sponsor as per standard Good Clinical Practice (GCP) requirements.
Time Frame
From baseline to 4 months
Title
Safety- Number of participants with significant changes to blood pressure over study period between groups
Description
Vital signs will be measured by a designee while the participant is seated. Resting blood pressure (systolic/diastolic mmHG) will be measured using an automated blood pressure monitor in a seated position following a 5-minute rest. The average of three measurements (separated by 2 minutes) will be recorded.Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety - Number of participants who fall pregnant (WOCBP only)
Description
A urine sample will be collected at Screening, Baseline, 2 and 4 month Visit or Early Withdrawal visit in WOCBP only. Study staff will perform a dipstick urine pregnancy test and record the result in the source documents.
Time Frame
Baseline to 4 months
Title
Safety - Number of participants with significant changes to heart rate between groups
Description
Vital signs will be measured by a designee while the participant is seated. Heart rate will be measured as beats/minute by palpating the participants' carotid and radial pulses. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Number of participants with changes to heart sounds
Description
The Medical Investigator will perform a non-invasive physical examination of the participants' cardiovascular system by listening to heart sounds to determine whether there is a heart murmur or irregular heart beat.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety - Number of participants with significant changes to respiratory rate between groups
Description
Respiratory rate will be measured by counting the number of times the chest rises per minute while the participant is at rest. Vital signs will be performed at Screening, Baseline, 2 month and 4 month or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Number of participants with changes to respiratory effort
Description
The Medical Investigator will perform a non-invasive physical examination of the participants' lung function by observing the participants' breathing rhythm and chest movement.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety - Number of participants with significant changes to core body temperature between groups
Description
Vital signs will be measured by a designee while the participant is seated. Body temperature (°C) will be measured using a digital thermometer.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with macroscopic abnormalities of the eyes
Description
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of the appearance of the pupil, iris, cornea, eyelids, eyelashes, conjuctiva and periorbital are including redness, discharge, lesions, ulcers, abrasions or unusual growths.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety -Number of participants with visual symptoms
Description
Participants will be asked to self-report on any visual symptoms or changes e.g. blurriness, eye strain etc. throughout the study period.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with infections in the Ears, Nose, Mouth and Throat
Description
A non-invasive physical examination will be performed by a Medical Investigator and will include
A visual assessment of the ears, nose, mouth and throat to check for signs of infection
Palpation of the cervical chain lymph nodes to check for signs of infection
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with changes to peripheral vascular function
Description
A non-invasive physical examination will be performed by a Medical Investigator and will include palpating the dorsal pedis pulse, posterior tibial pulse and palpation of the ankles to check for peripheral oedema.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with respiratory disease
Description
The Medical Investigator will perform a non-invasive physical examination of the participants' respiratory system by listening to breath sounds to determine whether there is untreated asthma or other lung disease.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with changes to the gastrointestinal tract
Description
Medical Investigator will perform a non-invasive physical exam by observing and palpating the participants' abdomen to check for surgical scars, ascites, organomegaly and abdominal discomfort.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Changes to characteristics in physical examination - musculoskeletal
Description
A non-invasive physical examination will be performed by a Medical Investigator and will include an assessment of joint mobility. Participants will be asked to to stand and sit back down into a chair unassisted, to reach forward and try to touch their toes, and to touch their opposite shoulder blades across their front, behind their neck and behind their back (Apley Shoulder test).
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with changes to characteristics in skin appearance
Description
A non-invasive physical examination will be performed by a Medical Investigator who will observe the participants' skin colour, looking for central and peripheral cyanosis, jaundice, or any skin rashes or lesions.
At Day 1 (Baseline visit) these will be reviewed to establish their baseline characteristics.
A symptom directed physical exam will be conducted at 4 months or Early Withdrawal Visit.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - AST
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Aspartate aminotransferase (AST) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry- ALT
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alanine aminotransferase (ALT) from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - GGT
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in gamma glutamyltransferase from baseline (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - ALP
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Alkaline phosphatase (ALP) (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - LD
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in Lactate Dehydrogenase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - creatinine
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine (µmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - creatinine kinase
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in creatinine kinase (U/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - urea nitrogen
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in urea nitrogen (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - sodium
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood sodium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - potassium
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood potassium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - chloride
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood chloride levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - bicarbonate
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood bicarbonate levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - urea
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in blood urea levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - calcium
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in calcium levels (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - CRP
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in C-reactive protein levels (CRP) measured as mg/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - uric acid
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in uric acid measured as mol/mol will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - phosphate
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in phosphate (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - albumin
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in albumin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - globulins
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in globulins (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - protein
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in protein (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - total bilirubin
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in total bilirubin (umol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in biochemistry - glucose
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in fasting glucose (mmol/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - RDW
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red cell distribution (RDW) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - haemoglobin
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in haemoglobin (g/L) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - RBC
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in red blood cell count (RBC) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - PCV
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in packed cell volume (PCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - MCV
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell volume (MCV) will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - MCHC
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in mean cell hemoglobin concentrations (MCHC) measured as g/L will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - platelets
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of platelets will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - white cell count (WCC)
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
Changes in the number of white cells will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - neutrophils
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of neutrophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - lymphocytes
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of lymphocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - monocytes
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of monocytes will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - eosinophils
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of eosinophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
Title
Safety: Number of participants with clinically significant changes in haematology - basophils
Description
Fasting blood samples will be collected at Screening, Baseline, 2 Month, 4 Month and Early Withdrawal visits.
A white cell count differential test will be conducted. Changes in the number of basophils will be analysed by a National Association of Testing Authorities, Australia (NATA) laboratory.
Time Frame
Baseline to 4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Male or female aged 18-65 inclusive
Fasting LDL-cholesterol ≥2.5mmol/L and ≤5mmol/L* confirmed at screening visit
Low cardiovascular disease (CVD) risk score (for individuals aged 45-65 years, inclusive) determined using Framingham Risk Equation <10% absolute risk of CVD events over 5 years# as determined using a risk calculator (1) or in the event that this is not available using Australian cardiovascular risk charts (2)
Body mass index (BMI) >18.5 kg/m2 and <35 kg/m2 confirmed during screening period and Day 1
Willing to provide written Informed Consent
Exclusion Criteria:
Serum LDL-cholesterol >5 mmol/L* at screening
Use of omega-3 supplements at high dose (>900 mg/day of docosahexaenoic acid (DHA) / eicosapentaenoic acid (EPA))
Use of and not prepared to abstain from lipid lowering medications, supplements or fortified foods containing substances that may, in the opinion of the medical investigator, affect lipid concentrations (e.g. statins, metformin, fibrates, cholesterol absorption inhibitors, nicotinic acid, or omega-3 supplements <900 mg/day DHA/EPA) , soluble fibre, e.g. β-glucan/psyllium, plant sterols, curcumin/turmeric) within past 28 days of Day 1
Previous diagnosis of chronic disease such as CVD, diabetes, cancer, familial hypercholesterolaemia, kidney disease
Smoking (i.e. history of smoking within the last six months)
Serum triglycerides >4.5mmol/L (LDL-cholesterol concentrations are unreliable in the presence of high triglyceride levels)
Women of childbearing potential (WOCBP) who:
Are not currently using effective methods of contraception and
Have not been using effective methods of contraception for 14 days prior to day 1 and
Are not willing to use effective methods of contraception throughout the study
WOCBP who have a positive urine dipstick pregnancy test at screening or Day 1, or currently pregnant or lactating
Untreated hypertension (blood pressure ≥140/90mmHg)
Aversion and/or intolerance/allergy to the study intervention products ^
Unwilling or unable to maintain usual levels of physical activity for the duration of the study
History of or known presence of alcohol abuse or illicit drug use, any surgical history, clinically significant conditions (i.e. renal, or urological disease, liver disease gastrointestinal disease or any other significant disease) or organ dysfunction that in the opinion of the investigator may affect the participant's ability to participate in the study or the study results
Currently hospitalised or any planned hospitalisations during the study or up to one month following the last dose of the study product that may affect the participant's ability to comply with the study in the opinion of the Medical Investigator
Received an investigational drug within 3 months prior to Day 1 that in the opinion of the investigator may affect the applicant's ability to participate in the study or the study results
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Welma Stonehouse, PhD
Organizational Affiliation
Commonwealth Scientific and Industrial Research Organisation, Australia
Official's Role
Principal Investigator
Facility Information:
Facility Name
CSIRO Nutrition and Health Research Clinic
City
Adelaide
State/Province
South Australia
ZIP/Postal Code
5000
Country
Australia
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Investigating Effects of a Novel Nutraceutical on Hypercholesterolaemia in Australian Adults
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