The Effect of Hesperidin on Glucose / Insulin Metabolism
Primary Purpose
Metabolic Syndrome, Obesity
Status
Completed
Phase
Phase 2
Locations
Netherlands
Study Type
Interventional
Intervention
Hesperidin
Placebo
Sponsored by
About this trial
This is an interventional prevention trial for Metabolic Syndrome
Eligibility Criteria
Inclusion Criteria:
* Subjects at risk for metabolic syndrome: a combination of 2 out of 5 components:
- Waist circumference: men > 102 cm / women > 88 cm
- Triglycerides: ≥ 1.7 mmol/l
- HDL-cholesterol: men ≤ 1.0 mmol/l / women ≤ 1.3 mmol/l
- Systolic blood pressure: ≥ 130 mmHg or diastolic blood pressure: ≥ 85 mmHg
- Fasted serum glucose ≥ 6.1 mmol/L
Exclusion Criteria:
- Type 2 diabetes mellitus (defined as fasting plasma glucose ≥7.0 mmol/l)
- Gastroenterological diseases or abdominal surgery
- Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
- Self-admitted HIV-positive status
- Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
- Smoking
- Plans to lose weight or following a hypocaloric diet during the study period
- Weight gain or loss > 3 kg in previous 3 months
- Use of medication interfering with endpoints
- Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
- Hormone replacement therapy (women).
- Use of antibiotics in the 90 days prior to the start of study
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
- Known pregnancy (assessed by a pregnancy test before start of study) or lactation
- Blood donation within 3 months before study period
- Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden products will be provided to participants
- History of any side effects towards the intake of flavonoids or citrus fruits
Sites / Locations
- MUMC+
Arms of the Study
Arm 1
Arm 2
Arm Type
Placebo Comparator
Active Comparator
Arm Label
Placebo
Hesperidin
Arm Description
Cellulose
Citrus peel extract
Outcomes
Primary Outcome Measures
Effect on blood glucose concentrations measured by oral glucose tolerance test
Secondary Outcome Measures
Effect on blood lipid profile
Effect on blood pressure
Effect on body composition measured by BMI
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Effect on low-grade inflammation measured by blood concentration of interleukin-6
Effect on gut barrier function measured by a sugar test
Full Information
NCT ID
NCT02610491
First Posted
November 16, 2015
Last Updated
November 19, 2015
Sponsor
Maastricht University Medical Center
1. Study Identification
Unique Protocol Identification Number
NCT02610491
Brief Title
The Effect of Hesperidin on Glucose / Insulin Metabolism
Official Title
The Effect of Hesperidin Administration on Glucose / Insulin Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
October 2015 (Actual)
Study Completion Date
October 2015 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Maastricht University Medical Center
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Metabolic Syndrome (MS) is a well-known group of obesity-related metabolic disorders including insulin resistance (IR), dyslipidemia and hypertension (HTN). In addition, overweight has a causal relationship with a chronic low grade systemic inflammatory condition and increased intestinal permeability. Over the last decade, this multiplex disorder has progressively become a major worldwide public health problem, because of its association with increased risk of type 2 diabetes mellitus (DM2), atherosclerotic cardiovascular disease and all-cause mortality. Scientific evidence for measures to improve cardiometabolic and intestinal health by non-pharmaceutical means are of urgent need. Administration of the flavonoid hesperidin to those at risk may have beneficial effects on glucose / insulin metabolism, lipid metabolism, blood pressure, heart rate, pro-inflammatory and oxidative stress biomarkers and gut barrier function.
Objective: To determine the 12-week effect of daily administration of hesperidin on the main cardiometabolic disorders related to MS as assessed by investigation of glucose/insulin metabolism, blood lipid profile, blood pressure, heart rate, body composition and gut barrier function in subjects at risk for MS.
Study design: This is a randomized, double-blind, placebo-controlled study with parallel design.
Study population: Healthy (male/female) volunteers, age 18-65, at risk for metabolic syndrome (presenting with 2 out of 5 of the components from NCEP-ATP-III criteria).
Intervention: Participants will be randomly assigned to one of the intervention groups. One group will receive one daily dose of hesperidin capsules while the other group receives identical looking placebo capsules for a period of 12 weeks. The capsules will have to be ingested with a glass of water every morning just before breakfast.
Main study parameters/endpoints: The primary efficacy parameter of this study is the oral glucose tolerance test (OGTT), a validated surrogate endpoint to study the β-cell function and insulin sensitivity. Secondary endpoints entail the evaluation of effects of daily administration of hesperidin on lipid profile (blood measurements), blood pressure and heart rate, body composition, low-grade inflammation biomarkers (blood measurements) and gut barrier function (blood measurements, fecal samples, urine collection).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metabolic Syndrome, Obesity
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
53 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Cellulose
Arm Title
Hesperidin
Arm Type
Active Comparator
Arm Description
Citrus peel extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Hesperidin
Intervention Description
Citrus peel extract
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo
Intervention Description
Cellulose
Primary Outcome Measure Information:
Title
Effect on blood glucose concentrations measured by oral glucose tolerance test
Time Frame
12 weeks
Secondary Outcome Measure Information:
Title
Effect on blood lipid profile
Time Frame
12 weeks
Title
Effect on blood pressure
Time Frame
12 weeks
Title
Effect on body composition measured by BMI
Time Frame
12 weeks
Title
Effect on low-grade inflammation measured by blood concentration of TNFalfa
Time Frame
12 weeks
Title
Effect on low-grade inflammation measured by blood concentration of interleukin-6
Time Frame
12 weeks
Title
Effect on gut barrier function measured by a sugar test
Time Frame
12 weeks
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:
* Subjects at risk for metabolic syndrome: a combination of 2 out of 5 components:
Waist circumference: men > 102 cm / women > 88 cm
Triglycerides: ≥ 1.7 mmol/l
HDL-cholesterol: men ≤ 1.0 mmol/l / women ≤ 1.3 mmol/l
Systolic blood pressure: ≥ 130 mmHg or diastolic blood pressure: ≥ 85 mmHg
Fasted serum glucose ≥ 6.1 mmol/L
Exclusion Criteria:
Type 2 diabetes mellitus (defined as fasting plasma glucose ≥7.0 mmol/l)
Gastroenterological diseases or abdominal surgery
Cardiovascular diseases, cancer, liver or kidney malfunction, thyroid disorders, disease with a life expectancy shorter than 5 years
Self-admitted HIV-positive status
Abuse of products; alcohol (> 20 alcoholic consumptions per week) and drugs
Smoking
Plans to lose weight or following a hypocaloric diet during the study period
Weight gain or loss > 3 kg in previous 3 months
Use of medication interfering with endpoints
Use of antioxidants, minerals and vitamin supplements available in pharmacies, drugstores, food markets or in alternative medicine
Hormone replacement therapy (women).
Use of antibiotics in the 90 days prior to the start of study
Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator) in the 180 days prior to the study
Known pregnancy (assessed by a pregnancy test before start of study) or lactation
Blood donation within 3 months before study period
Failure to comply prohibited intake of hesperidin containing food products during study period. A list with forbidden products will be provided to participants
History of any side effects towards the intake of flavonoids or citrus fruits
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ad Masclee, MD
Organizational Affiliation
Maastricht University Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
MUMC+
City
Maastricht
State/Province
Limburg
ZIP/Postal Code
6221EG
Country
Netherlands
12. IPD Sharing Statement
Learn more about this trial
The Effect of Hesperidin on Glucose / Insulin Metabolism
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