Obesity, Overweight
Conditions
Keywords
Polyphenols, Endothelial function, Gut barrier function
Brief summary
This randomized, double-blind, placebo-controlled, parallel study aims to determine the 6-week and acute effects of daily administration of a citrus flavonoid on cardiovascular and intestinal health as assessed by investigation of endothelial function, blood pressure and heart rate, glucose/insulin metabolism, lipid profile and gut barrier function in overweigh subjects. Futhermore we aim to relate the specific intestinal (microbial) metabolism with final serum levels of specific metabolites of the study product.
Interventions
DIETARY_SUPPLEMENTCapsule containing citrus flavonoid
DIETARY_SUPPLEMENTPlacebo
Sponsors
Maastricht University Medical Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
TRIPLE (Subject, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
Inclusion criteria
* Overweight men/women (BMI 25-35 kg/m2) * Healthy individuals * Age between 18 and 70 years * Fasting glucose \< 7.0 mmol/L * Normal HbA1c (4.4 to 6.2%)
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 * Intake of antihypertensive medication, statins, corticosteroids, NSAIDs, ciclosporin A, rifampicin are strictly forbidden * 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), lactation * Blood donation within 3 months before study period * Failure to comply prohibited intake of hesperidin containing food products during study period and prohibited intake of food products that are able to influence the FMD measurements one day prior to test days. * History of any side effects towards the intake of flavonoids or citrus fruits
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | 6 weeks | The primary objective of this study is to evaluate the efficacy on endothelial function, as assessed by flow mediated dilatation (FMD) measurements, after 6 weeks of administration of study product. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Blood pressure & heart rate | 6 weeks | The third objective of this study is to assess the 6-week effect on blood pressure and heart rate by measuring systolic and diastolic blood pressure and heart rate. |
| Glucose / insulin metabolism | 6 weeks | The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements. |
| Lipid profile | 6 weeks | The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements. |
| Endothelial function | 6 weeks | The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation. |
| Colonic inflammation | 6 weeks | The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin. |
| Bioavailability and metabolism | 5 days | The eight secondary objective of this study is to enlarge the understanding of the bioavailability and metabolism of this study product in human beings, by relating specific intestinal (microbial) metabolism with serum levels of its metabolites. |
| Gut barrier function | 6 weeks | The fifth secondary objective of this study is to assess the acute and 6-week effect on gut barrier function by measuring plasma and fecal endotoxin (LPS) and zonulin. |
Countries
Netherlands
Outcome results
None listed