The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males

May 27, 2016 updated by: Jeremy Paul Edward Spencer, University of Reading
A randomised, placebo-controlled, parallel human dietary intervention trial conducted in 33 healthy males to investigate the vascular and cognitive effects of bi-daily consumption of high-flavanol (epicatechin-rich) milk chocolate over a 2-week intervention period. Subjects visited the Hugh Sinclair Unit of Human Nutrition on 3 separate occasions; at the beginning, end and post-intervention.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

34

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 40 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

Inclusion Criteria

  • Body Mass Index 18.5-27.5 kg/m2
  • Normal Blood pressure (< 150/90)
  • Non-smoker
  • Regular exercise routine
  • Signed consent form

Exclusion Criteria:

  • Haemoglobin (anaemia marker) < 125 g/l
  • Gamma GT (liver enzymes) > 80 IU/l
  • Total Cholesterol > 6.5 mmol/l
  • Suffered a myocardial infarction or stroke in the last 12 months
  • Suffers from any cardiovascular or metabolic disorders
  • Suffers from any blood-clotting disorder, and/or takes supporting medication
  • Any dietary restrictions or on a weight reducing diet
  • On any lipid-modifying or blood pressure lowering medication
  • Consuming any specific vitamin/ herbal supplements or fish oils

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High-flavanol milk chocolate
Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days)
Dietary supplement: High-flavanol milk choocolate
Other Names:
  • Epicatechin-rich milk chocolate
Placebo Comparator: Low-flavanol milk chocolate
Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days)
Dietary supplement: Low-flavanol milk chocolate

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Flow-mediated Dilation (FMD)
Time Frame: Change from baseline at 14 days
Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia
Change from baseline at 14 days

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Blood pressure (BP)
Time Frame: Change from baseline at 14 days
Acute assessment of systolic and diastolic BP (3 repeats)
Change from baseline at 14 days
Executive Function
Time Frame: Change from baseline at 14 days
Assessed by cognitive test battery
Change from baseline at 14 days
Endothelial progenitor cells and Microparticles
Time Frame: Change from baseline at 14 days
Flow cytometric analysis using whole blood
Change from baseline at 14 days
Plasma flavanol metabolite analysis
Time Frame: Change from baseline at 14 days
HPLC-MS assessment of metabolite profile and content of plasma
Change from baseline at 14 days
Plasma Nitrite & Nitrate analysis
Time Frame: Change from baseline at 14 days
HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite & Nitrate in plasma
Change from baseline at 14 days
Serum analysis of cardivascular-related blood marker(s) concentration
Time Frame: Change from baseline at 14 days
ILAB assessment of serum content of glucose, Triglycerides, total cholesterol, HDL-cholesterol, C-reactive protein and Non-esterified fatty acids
Change from baseline at 14 days
Serum analysis of insulin
Time Frame: Change from baseline at 14 days
ELIZA kits for determination of insulin concentration in serum
Change from baseline at 14 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Principal Investigator: Jeremy P Spencer, PhD, Univerisity of Reading

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2016

Primary Completion (Anticipated)

June 1, 2016

Study Completion (Anticipated)

June 1, 2016

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

May 27, 2016

First Posted (Estimate)

June 3, 2016

Study Record Updates

Last Update Posted (Estimate)

June 3, 2016

Last Update Submitted That Met QC Criteria

May 27, 2016

Last Verified

May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • MCStudy

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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