An interventional study of Capsule containing citrus flavonoid and Placebo in Obesity and Overweight, sponsored by Maastricht University Medical Center. Completed at 1 site in Netherlands. Open to participants aged 18 Years to 70 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2015-07-08.
Sponsored by Maastricht University Medical Center · Not applicable, Interventional, and Treatment
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.
3,670 studies on the registry are indexed under Overweight; 849 are open to participants now.
This study's enrollment of 68 is close to the median of 73 across 3,175 interventional studies indexed under Overweight.
Browse Overweight studies →Maastricht University Medical Center is the lead sponsor of 835 studies on the registry; 122 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Cellulose
Dietary Supplement: Placebo
Citric flavonoid
Dietary Supplement: Capsule containing citrus flavonoid
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.
Time frame: 6 weeks
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.
Time frame: 6 weeks
Blood pressure & heart rate
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.
Time frame: 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.
Time frame: 6 weeks
Lipid profile
The fourth secondary objective of this study is to determine the 6-week effect on lipid profile by blood measurements.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 5 days
This study is completed, as verified in Jul 2015. You cannot join it, but the record below documents what was studied.
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Maastricht University Medical Center