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Trial record 20 of 84 for:    catechin

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

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ClinicalTrials.gov Identifier: NCT01691404
Recruitment Status : Completed
First Posted : September 24, 2012
Last Update Posted : April 23, 2013
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Wageningen University

Tracking Information
First Submitted Date  ICMJE September 12, 2012
First Posted Date  ICMJE September 24, 2012
Last Update Posted Date April 23, 2013
Study Start Date  ICMJE September 2012
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: September 19, 2012)
Change in Endothelium-dependent flow-mediated dilation as a result of epicatechin and quercetin-3-glucoside supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
Change in arterial diameter as a result of 5 minute arterial occlusion (200mmHg). Arterial diameter will be measured by means of ultrasonography.
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT01691404 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: September 24, 2012)
  • Change in blood pressure as a result of epicatechin and quercetin-3-glucoside supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Office BP (Dinamap, 4 consecutive measurements with 2-min intervals)and 24-hour ABPM (Spacelab; 1x24h)
  • Change in pulse wave velocity as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a SphygmoCor device at baseline and the end of each intervention
  • Change in vasomotion as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a PeriFlux 5001 device at baseline and the end of each intervention.
  • Changes in biomarkers of endothelial function as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-α, vWF, nitric oxide
  • Changes in peripheral blood mononuclear cell gene expression of markers of inflammation as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    PBMC gene expression of markers of inflammation
  • Change in cardiovascular parameters in plasma as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose
  • Changes in pulse wave analysis as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a SphygmoCor device at baseline and the end of each intervention
  • Adverse events [ Time Frame: Baseline and every 2 weeks thereafter (weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20) ]
    During the study subjects will be asked to maintain a diary in which they can report any adverse events they may have a result of the supplements. Diaries will be checked every 2 weeks. Study subjects will also be asked to contact the research team if they experience repeated adverse events.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 19, 2012)
  • Change in blood pressure as a result of epicatechin and quercetin-3-glucoside supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Office BP (Dinamap, 4 consecutive measurements with 2-min intervals)and 24-hour ABPM (Spacelab; 1x24h)
  • Change in pulse wave velocity as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a SphygmoCor device at baseline and the end of each intervention
  • Change in vasomotion as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a PeriFlux 5001 device at baseline and the end of each intervention.
  • Changes in biomarkers of endothelial function as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Plasma analysis of endothelin-1, ADMA, MCP-1, sVCAM-1, sICAM-1, sE-selectin, sTM, CRP, SAA, IL-6, IL-8, TNF-α, vWF, nitric oxide
  • Changes in peripheral blood mononuclear cell gene expression of markers of inflammation as a result of epicatechin and quercetin supplemention [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    PBMC gene expression of markers of inflammation
  • Change in cardiovascular parameters in plasma as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Total cholesterol, HDL-cholesterol, LDL-cholesterol, triglycerides, insulin and glucose
  • Changes in pulse wave analysis as a result of epicatechin and quercetin supplementation [ Time Frame: Baseline and every 4 weeks thereafter (weeks 4, 8, 12, 16 and 20) ]
    Measured using a SphygmoCor device at beaseline and the end of each interevention
  • Adverse events [ Time Frame: Baseline and every 2 weeks thereafter (weeks 2, 4, 6, 8, 10, 12, 14, 16, 18 and 20) ]
    During the study subjects will be asked to maintain a diary in which they can report any adverse events they may have a result of the supplements. Diaries will be checked every 2 weeks. Study subjects will also be asked to contact the research team if they experience repeated adverse events.
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure (FLAVO)
Official Title  ICMJE Study on the Effects of Epicatechin and Quercetin Supplementation on Vascular Function and Blood Pressure in Untreated (Pre)Hypertensive Subjects
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.

Detailed Description

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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Hypertension
  • Endothelial Dysfunction
Intervention  ICMJE
  • Dietary Supplement: Epicatechin
    Subjects will be asked to consume supplements containing 100mg of epicatechin daily
  • Dietary Supplement: Quercetin
    Subjects will be asked to consume 160mg of quercetin-3-glucoside daily
  • Dietary Supplement: Placebo
    Subjects will be asked to consume capsules containing placebo (cellulose) daily
Study Arms  ICMJE
  • Active Comparator: Epicatechin
    Subjects will be asked to consume supplements containing 100mg of epicatechin daily
    Intervention: Dietary Supplement: Epicatechin
  • Active Comparator: Quercetin
    Subjects will be asked to consume supplements containing 160mg of quercetin-3-glucoside daily
    Intervention: Dietary Supplement: Quercetin
  • Placebo Comparator: Placebo
    Subjects will be asked to consume capsules containing a placebo (cellulose) daily
    Intervention: Dietary Supplement: Placebo
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 22, 2013)
38
Original Estimated Enrollment  ICMJE
 (submitted: September 19, 2012)
40
Actual Study Completion Date  ICMJE March 2013
Actual Primary Completion Date March 2013   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 30 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Netherlands
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01691404
Other Study ID Numbers  ICMJE NL4077208112
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Wageningen University
Study Sponsor  ICMJE Wageningen University
Collaborators  ICMJE Top Institute Food and Nutrition
Investigators  ICMJE
Principal Investigator: Peter Hollman, PhD Wageningen University
PRS Account Wageningen University
Verification Date November 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP