Overview

This trial is active, not recruiting.

Condition healthy
Treatments high-flavanol milk choocolate, low-flavanol milk chocolate
Sponsor University of Reading
Start date January 2016
End date June 2016
Trial size 34 participants
Trial identifier NCT02789761, MCStudy

Summary

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose prevention
Arm
(Active Comparator)
Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days)
high-flavanol milk choocolate Epicatechin-rich milk chocolate
(Placebo Comparator)
Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately <1 mg of (-)-epicatechin for 2-weeks (14 days)
low-flavanol milk chocolate

Primary Outcomes

Measure
Flow-mediated Dilation (FMD)
time frame: Change from baseline at 14 days

Secondary Outcomes

Measure
Blood pressure (BP)
time frame: Change from baseline at 14 days
Executive Function
time frame: Change from baseline at 14 days
Endothelial progenitor cells and Microparticles
time frame: Change from baseline at 14 days
Plasma flavanol metabolite analysis
time frame: Change from baseline at 14 days
Plasma Nitrite & Nitrate analysis
time frame: Change from baseline at 14 days
Serum analysis of cardivascular-related blood marker(s) concentration
time frame: Change from baseline at 14 days
Serum analysis of insulin
time frame: Change from baseline at 14 days

Eligibility Criteria

Male participants from 18 years up to 40 years old.

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

Additional Information

Official title The Vascular and Cognitive Effects of Chronic High-flavanol Intake in Healthy Males
Principal investigator Jeremy P Spencer, PhD
Trial information was received from ClinicalTrials.gov and was last updated in May 2016.
Information provided to ClinicalTrials.gov by University of Reading.