Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)

NCT01691404 | Completed

• 1 other identifier: NL4077208112
• Study Type: interventional
• Target: 38
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hypertension; Endothelial Dysfunction

Keywords

Flavonoids; Quercetin; Epicatechin; Vascular function; Blood pressure; Endothelial function

Outcome Measures

Primary Outcomes (1)

• Change in Endothelium-dependent flow-mediated dilation as a result of epicatechin and quercetin-3-glucoside supplementation

  Change in arterial diameter as a result of 5 minute arterial occlusion (200mmHg). Arterial diameter will be measured by means of ultrasonography.

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

Secondary Outcomes (8)

• Change in blood pressure as a result of epicatechin and quercetin-3-glucoside supplementation

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

• Change in pulse wave velocity as a result of epicatechin and quercetin supplementation

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

• Change in vasomotion as a result of epicatechin and quercetin supplementation

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

• Changes in biomarkers of endothelial function as a result of epicatechin and quercetin supplementation

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

• Changes in peripheral blood mononuclear cell gene expression of markers of inflammation as a result of epicatechin and quercetin supplementation

  Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20)

Study Arms (3)

Epicatechin

ACTIVE COMPARATOR

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

Dietary Supplement: Epicatechin

Quercetin

ACTIVE COMPARATOR

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

Dietary Supplement: Quercetin

Placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Epicatechin DIETARY_SUPPLEMENT

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

Epicatechin

Quercetin DIETARY_SUPPLEMENT

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

Quercetin

Placebo DIETARY_SUPPLEMENT

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

Placebo

Eligibility Criteria

• Age: 30 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Wageningen University: lead
• Top Institute Food and Nutrition: collaborator

Study Sites (1)

Wageningen University

Wageningen, 6703 HD, Netherlands

Location

Related Publications (3)

• 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.

  PMID: 30398646 DERIVED

• 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.

  PMID: 25972527 DERIVED

• 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.

  PMID: 25934864 DERIVED

Related Links

• Website for the study (in dutch)

MeSH Terms

Conditions

Hypertension

Interventions

Catechin; Quercetin

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases

Intervention Hierarchy (Ancestors)

Chromans; Benzopyrans; Pyrans; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Flavonoids; Chromones; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Flavonols

Study Officials

• Peter Hollman, PhD

  Wageningen University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 12, 2012
• First Posted: September 24, 2012
• Study Start: September 1, 2012
• Primary Completion: March 1, 2013
• Study Completion: March 1, 2013
• Last Updated: April 23, 2013

Record last verified: 2012-11

Locations

NL (1)