Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)
NCT ID: NCT01691404
Last Updated: 2013-04-23
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
38 participants
INTERVENTIONAL
2012-09-30
2013-03-31
Brief Summary
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During this study the investigators plan to investigate the effects of pure epicatechin and quercetin supplementation on vascular function and blood pressure in untreated (prehypertensive) subjects by way of a three-armed double-blind crossover intervention. Participants will sequentially consume supplements containing quercetin, epicatechin or placebo for a period of 4 weeks. Before and after this 4 week period, measurements of vascular function and blood pressure will be taken.
The investigators hypothesize that the supplementation of epicatechin and quercetin will improve vascular function and blood pressure.
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Detailed Description
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Measurements of vascular function will include flow-mediated dilation, pulse wave analysis, pulse wave velocity and vasomotion as well as biomarkers of inflammation and vascular function.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
BASIC_SCIENCE
TRIPLE
Study Groups
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Epicatechin
Subjects will be asked to consume supplements containing 100mg of epicatechin daily
Epicatechin
Subjects will be asked to consume supplements containing 100mg of epicatechin daily
Quercetin
Subjects will be asked to consume supplements containing 160mg of quercetin-3-glucoside daily
Quercetin
Subjects will be asked to consume 160mg of quercetin-3-glucoside daily
Placebo
Subjects will be asked to consume capsules containing a placebo (cellulose) daily
Placebo
Subjects will be asked to consume capsules containing placebo (cellulose) daily
Interventions
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Epicatechin
Subjects will be asked to consume supplements containing 100mg of epicatechin daily
Quercetin
Subjects will be asked to consume 160mg of quercetin-3-glucoside daily
Placebo
Subjects will be asked to consume capsules containing placebo (cellulose) daily
Eligibility Criteria
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Inclusion Criteria
* Age between 30 and 80 years
* BMI \> 20 and ≤ 40
* No reported current or previous metabolic diseases
* No history of cardiovascular diseases
* No history of renal, liver or thyroid diseases
* No history of gastrointestinal diseases
* No diabetes mellitus
* Fasting laboratory parameters within normal range: complete blood count (RBC, WBC, PLT, HB, HT), renal function (serum creatinine, urea), liver function (ALAT, ASAT, ɣ-GT), and serum glucose.
Exclusion Criteria
* Secondary hypertension
* Weight loss or weight gain of 5 kg or more during the last 2 months
* Usage of non-steroidal anti-inflammatory drugs (acetylsalicylic acid, ibuprofen, naproxen) and not able or willing to stop taking them from at least 4 weeks prior to the study
* Usage of cholesterol-lowering medication
* Daily usage of corticosteroids
* Medical treatment that may affect blood pressure and not able (or willing) to stop
* Taking nutritional supplements and unwilling to discontinue
* Lactating, pregnant or intention to become pregnant during study
* Reported dietary habits, medically prescribed diet, slimming diet
* Reported average alcohol consumption \> 2 glasses/d (men) or \>1 glass/d (women)
* Problems with consuming the supplements or following the study guidelines
* Unwilling to undergo home or office blood pressure measurements
* Recent blood donation i.e. 1 month (male subjects) or 2 months (female subjects) prior to the study and planned donation during the study period
* Reported intense sporting activities \> 10 h/w
* Not agreeing to be informed about unexpected and medically relevant personal test-results, or not agreeing that their general practitioner will be informed about these results
* Participation in another biomedical trial less than 2 months before the start of the study or at the same time
* No signed informed consent form
* Clinical disorders that could interfere with the intervention
* Unable to comply with the study procedure (e.g. holidays, urine collection, blood sampling)
* Smokers
* Difficulty imaging brachial artery by ultrasonography
30 Years
80 Years
ALL
Yes
Sponsors
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Top Institute Food and Nutrition
OTHER
Wageningen University
OTHER
Responsible Party
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Principal Investigators
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Peter Hollman, PhD
Role: PRINCIPAL_INVESTIGATOR
Wageningen University
Locations
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Wageningen University
Wageningen, , Netherlands
Countries
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References
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Van den Eynde MDG, Geleijnse JM, Scheijen JLJM, Hanssen NMJ, Dower JI, Afman LA, Stehouwer CDA, Hollman PCH, Schalkwijk CG. Quercetin, but Not Epicatechin, Decreases Plasma Concentrations of Methylglyoxal in Adults in a Randomized, Double-Blind, Placebo-Controlled, Crossover Trial with Pure Flavonoids. J Nutr. 2018 Dec 1;148(12):1911-1916. doi: 10.1093/jn/nxy236.
Dower JI, Geleijnse JM, Gijsbers L, Schalkwijk C, Kromhout D, Hollman PC. Supplementation of the Pure Flavonoids Epicatechin and Quercetin Affects Some Biomarkers of Endothelial Dysfunction and Inflammation in (Pre)Hypertensive Adults: A Randomized Double-Blind, Placebo-Controlled, Crossover Trial. J Nutr. 2015 Jul;145(7):1459-63. doi: 10.3945/jn.115.211888. Epub 2015 May 13.
Dower JI, Geleijnse JM, Gijsbers L, Zock PL, Kromhout D, Hollman PC. Effects of the pure flavonoids epicatechin and quercetin on vascular function and cardiometabolic health: a randomized, double-blind, placebo-controlled, crossover trial. Am J Clin Nutr. 2015 May;101(5):914-21. doi: 10.3945/ajcn.114.098590. Epub 2015 Feb 25.
Related Links
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Website for the study (in dutch)
Other Identifiers
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NL4077208112
Identifier Type: -
Identifier Source: org_study_id
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