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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | Cellulose |
|
| Citric flavonoid | Experimental | Citric flavonoid |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Capsule containing citrus flavonoid | Dietary Supplement |
| ||
| Placebo |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | 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. | 6 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | The second secondary objective of this study is to determine the 6-week effect on plasma biomarkers of endothelial dysfunction and low-grade inflammation. | 6 weeks |
| Blood pressure & heart rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| A.A.M. Masclee, MD, PhD | Department of Internal Medicine, Division of Gastroenterology-Hepatology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Limburg | 6229HX | Netherlands |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 27797708 | Derived | Salden BN, Troost FJ, de Groot E, Stevens YR, Garces-Rimon M, Possemiers S, Winkens B, Masclee AA. Randomized clinical trial on the efficacy of hesperidin 2S on validated cardiovascular biomarkers in healthy overweight individuals. Am J Clin Nutr. 2016 Dec;104(6):1523-1533. doi: 10.3945/ajcn.116.136960. Epub 2016 Oct 26. |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| D050177 | Overweight |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| Dietary Supplement |
|
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.
| 6 weeks |
| Glucose / insulin metabolism | The fourth secondary objective of this study is to determine the 6-week effect on glucose / insulin metabolism by blood measurements. | 6 weeks |
| Lipid profile | The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements. | 6 weeks |
| Gut barrier function | 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. | 6 weeks |
| Gut barrier function | The sixth secondary objective of this study is to assess the 6-week effect of on gut barrier function by performing a gut sugar permeability test. | 6 weeks |
| Colonic inflammation | The seventh secondary objective of this study is to assess the 6-week effect on colonic inflammation, by measuring fecal calprotectin. | 6 weeks |
| Bioavailability and metabolism | 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. | 5 days |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |