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

Results pending

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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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

38 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-09-30

Study Completion Date

2013-03-31

Brief Summary

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Flavonoid-rich foods such as tea and cocoa have been identified as having a blood pressure-lowering effect. Part of this effect is thought to be due to the flavonoid content of these foods although it is currently unknown which flavonoids play a role. Epicatechin is one the major flavonoids in cocoa while quercetin is largely found in tea.

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.

Detailed Description

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By means of a three-armed double-blind crossover intervention, the effects of pure flavonoid supplementation will be investigated. The products under investigation will be epicatechin and quercetin-3-glucoside. Subjects will be asked to consume either 160mg of quercetin-3-glucoside, 100mg of epicatechin or a placebo capsule for a period of 4 weeks. Measurements of vascular function and blood pressure will be taken before and after each 4-week intervention period. A 4-week washout period will be planned between each intervention.

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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Hypertension Endothelial Dysfunction

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Epicatechin

Subjects will be asked to consume supplements containing 100mg of epicatechin daily

Group Type ACTIVE_COMPARATOR

Epicatechin

Intervention Type DIETARY_SUPPLEMENT

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

Group Type ACTIVE_COMPARATOR

Quercetin

Intervention Type DIETARY_SUPPLEMENT

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

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Intervention Type DIETARY_SUPPLEMENT

Quercetin

Subjects will be asked to consume 160mg of quercetin-3-glucoside daily

Intervention Type DIETARY_SUPPLEMENT

Placebo

Subjects will be asked to consume capsules containing placebo (cellulose) daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* Systolic Blood Pressure between 125 and 160 mmHg
* 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

* Body mass index \> 40 and ≤20
* 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
Minimum Eligible Age

30 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Top Institute Food and Nutrition

OTHER

Sponsor Role collaborator

Wageningen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Peter Hollman, PhD

Role: PRINCIPAL_INVESTIGATOR

Wageningen University

Locations

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Wageningen University

Wageningen, , Netherlands

Site Status

Countries

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Netherlands

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.

Reference Type DERIVED
PMID: 30398646 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25972527 (View on PubMed)

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.

Reference Type DERIVED
PMID: 25934864 (View on PubMed)

Related Links

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http://voedingsonderzoek.wur.nl/flavo

Website for the study (in dutch)

Other Identifiers

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NL4077208112

Identifier Type: -

Identifier Source: org_study_id

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