Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Primary Purpose
Metabolic Syndrome
Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Fruit concentrate - either cherry or blueberry
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
- Healthy
- 18 years of age and above
- Non-smoker
- BMI < 30
- Able to give informed consent
Exclusion Criteria:
- Pregnancy
- Diabetes or any other metabolic/ uncontrolled hypertensive conditions
- Food allergies to cherries or blueberries
- Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
- Not regularly taking medication or antioxidant supplements
Sites / Locations
- University of Central Lancashire
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Placebo Comparator
Experimental
Experimental
Arm Label
Placebo
Cherry juice
Blueberry
Arm Description
Identical in taste and colour to the supplement juice, but with no anthocyanin content
30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Outcomes
Primary Outcome Measures
Blood pressure
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
% bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
% bodyfat
Participants percentage composition of fat - measured using bio-electrical impedance
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Waist to hip ratio
Ratio of waist to hip circumference - measured using anthropocentric tape
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting metabolic rate
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of carbohydrates
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Resting utilization of fats
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity calories expended
Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity calories expended
Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of fats
% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of fats
% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of carbohydrates
% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Low-moderate intensity activity utilization of carbohydrates
% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Blood glucose
Capillary blood glucose - mmol/L
Blood glucose
Capillary blood glucose - mmol/L
Blood triglycerides
Capillary blood triglycerides - mmol/L
Blood triglycerides
Capillary blood triglycerides - mmol/L
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Blood cholesterol (Total, HDL & LDL)
Capillary blood cholesterol - mmol/L
Blood haemoglobin
Capillary blood haemoglobin - g/L
Blood haemoglobin
Capillary blood haemoglobin - g/L
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Coop-Wonka chart
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Beck Depression Inventory
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
State Trait Anxiety Inventory
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Insomnia Severity Index
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Pittsburgh Sleep Quality Index
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Epworth Sleepiness Scale
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Secondary Outcome Measures
Full Information
NCT ID
NCT04177238
First Posted
November 21, 2019
Last Updated
October 31, 2022
Sponsor
University of Central Lancashire
1. Study Identification
Unique Protocol Identification Number
NCT04177238
Brief Title
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Official Title
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
Study Type
Interventional
2. Study Status
Record Verification Date
October 2022
Overall Recruitment Status
Completed
Study Start Date
January 21, 2020 (Actual)
Primary Completion Date
February 5, 2022 (Actual)
Study Completion Date
August 5, 2022 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Central Lancashire
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Cardiovascular disease, type 2 diabetes mellitus and associated diseases combined are the leading health burden and cause of mortality worldwide; therefore, the necessity for an intervention is paramount. Dietary interventions to improve cardiometabolic health are highly sought after as they possess less risk than pharmacological drugs. Anthocyanins, found in high quantities in both tart cherries and blueberries are powerful antioxidants, that are potentially capable of improving cardiometabolic dysfunction. However, to date, no research has explored the cardiometabolic responses to tart cherry and blueberry supplementation.
Therefore, the primary purpose of the proposed investigation is to test the ability of oral tart cherry and blueberry supplementation to improve cardiometabolic parameters in healthy individuals.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Identical in taste and colour to the supplement juice, but with no anthocyanin content
Arm Title
Cherry juice
Arm Type
Experimental
Arm Description
30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Arm Title
Blueberry
Arm Type
Experimental
Arm Description
30 mL of tart juice concentrate, which will be diluted with 100 mL of water - taken twice per day,
Intervention Type
Dietary Supplement
Intervention Name(s)
Fruit concentrate - either cherry or blueberry
Intervention Description
Fruit (cherry or blueberry concentrate) supplement from a company named Active-Edge (https://active-edge.co.uk/).
Primary Outcome Measure Information:
Title
Blood pressure
Description
Systolic and diastolic blood pressure - measured using a digital blood pressure monitor
Time Frame
Baseline
Title
% bodyfat
Description
Participants percentage composition of fat - measured using bio-electrical impedance
Time Frame
Baseline
Title
% bodyfat
Description
Participants percentage composition of fat - measured using bio-electrical impedance
Time Frame
20 days
Title
Waist to hip ratio
Description
Ratio of waist to hip circumference - measured using anthropocentric tape
Time Frame
Baseline
Title
Waist to hip ratio
Description
Ratio of waist to hip circumference - measured using anthropocentric tape
Time Frame
20 days
Title
Resting metabolic rate
Description
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting metabolic rate
Description
Estimated daily calorie usage (Kcal) at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Resting utilization of carbohydrates
Description
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting utilization of carbohydrates
Description
% contribution of carbohydrate to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Resting utilization of fats
Description
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Resting utilization of fats
Description
% contribution of fats to daily calories - at rest - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Low-moderate intensity activity calories expended
Description
Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Low-moderate intensity activity calories expended
Description
Estimated calorie usage (Kcal) during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Low-moderate intensity activity utilization of fats
Description
% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Low-moderate intensity activity utilization of fats
Description
% contribution of fats to calorie expenditure - during low-moderate intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Low-moderate intensity activity utilization of carbohydrates
Description
% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
Baseline
Title
Low-moderate intensity activity utilization of carbohydrates
Description
% contribution of carbohydrates to calorie expenditure - during low intensity walking exercise - obtained using a metabolic cart through indirect calorimetry.
Time Frame
20 days
Title
Blood glucose
Description
Capillary blood glucose - mmol/L
Time Frame
Baseline
Title
Blood glucose
Description
Capillary blood glucose - mmol/L
Time Frame
20 days
Title
Blood triglycerides
Description
Capillary blood triglycerides - mmol/L
Time Frame
Baseline
Title
Blood triglycerides
Description
Capillary blood triglycerides - mmol/L
Time Frame
20 days
Title
Blood cholesterol (Total, HDL & LDL)
Description
Capillary blood cholesterol - mmol/L
Time Frame
Baseline
Title
Blood cholesterol (Total, HDL & LDL)
Description
Capillary blood cholesterol - mmol/L
Time Frame
20 days
Title
Blood haemoglobin
Description
Capillary blood haemoglobin - g/L
Time Frame
Baseline
Title
Blood haemoglobin
Description
Capillary blood haemoglobin - g/L
Time Frame
20 days
Title
Coop-Wonka chart
Description
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Time Frame
Baseline
Title
Coop-Wonka chart
Description
Psychological wellbeing - The Coop-Wonka chart is a six item questionnaire with a 1-5 scoring system for each thus the chart has a maximum score of 30 which indicates the lowest possible psychological Wellbeing.
Time Frame
20 days
Title
Beck Depression Inventory
Description
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Time Frame
Baseline
Title
Beck Depression Inventory
Description
Psychological wellbeing - the Beck Depression Inventory is a 21 questionnaire with questions that range in scoring from 0-3, thus the maximum score is 63 which is the highest depression score possible.
Time Frame
20 days
Title
State Trait Anxiety Inventory
Description
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Time Frame
Baseline
Title
State Trait Anxiety Inventory
Description
Psychological wellbeing - the state trait anxiety inventory is a 40 item questionnaire with each question having a 1-4 score system, thus the maximum score is 80 which indicates the highest level of anxiety.
Time Frame
20 days
Title
Insomnia Severity Index
Description
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Time Frame
Baseline
Title
Insomnia Severity Index
Description
Sleep quality - The Insomnia Severity Index is a brief instrument designed to assess the severity of both nighttime and daytime components of insomnia. The Insomnia Severity Index is a 7-item self-report questionnaire yielding a total score ranging from 0 to 28.
Time Frame
20 days
Title
Pittsburgh Sleep Quality Index
Description
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Time Frame
Baseline
Title
Pittsburgh Sleep Quality Index
Description
Sleep quality - The Pittsburgh Sleep Quality index, is a questionnaire that consists of 19 self-rated questions, grouped into 7 components. Each component is scored separately, weighted equally on a 0 - 3 scale and the scores of the 7 components are then added to give a global score, which has a range of 0 - 21 with higher scores indicating worse sleep quality.
Time Frame
20 days
Title
Epworth Sleepiness Scale
Description
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Time Frame
Baseline
Title
Epworth Sleepiness Scale
Description
Sleep quality - The Epworth Sleepiness Scale is a self-administered questionnaire with 8 questions. Respondents are asked to rate, on a 4-point scale (0-3) with a maximum score of 24.
Time Frame
20 days
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:
Healthy
18 years of age and above
Non-smoker
BMI < 30
Able to give informed consent
Exclusion Criteria:
Pregnancy
Diabetes or any other metabolic/ uncontrolled hypertensive conditions
Food allergies to cherries or blueberries
Habitual consumption of blueberries/ cherries and/or blueberry/ cherry products
Not regularly taking medication or antioxidant supplements
Facility Information:
Facility Name
University of Central Lancashire
City
Preston
State/Province
Lancashire
ZIP/Postal Code
PR4 0PE
Country
United Kingdom
12. IPD Sharing Statement
Citations:
PubMed Identifier
34574679
Citation
Sinclair J, Shadwell G, Dillon S, Allan R, Butters B, Bottoms L. Effects of Montmorency Tart Cherry and Blueberry Juice on Cardiometabolic Outcomes in Healthy Individuals: Protocol for a 3-Arm Placebo Randomized Controlled Trial. Int J Environ Res Public Health. 2021 Sep 16;18(18):9759. doi: 10.3390/ijerph18189759.
Results Reference
derived
Learn more about this trial
Effects of Oral Fruit Concentrate Supplementation on Cardiometabolic Parameters.
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