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

Not Applicable

• Conditions: Healthy
• Interventions: Dietary Supplement: High-flavanol milk choocolate; Dietary Supplement: Low-flavanol milk chocolate

• Registration Number: NCT02789761
• Lead Sponsor: University of Reading

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2016-01
• Study First Submitted: 2016-04-25
• Status Verified: 2016-05
• Study First Submitted QC: 2016-05-27
• Last Update Submitted: 2016-05-27
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Study First Posted: 2016-06-03
• Last Update Posted: 2016-06-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Male
• Target Recruitment: 34

Inclusion Criteria

Not provided

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
High-flavanol milk chocolate	High-flavanol milk choocolate	Bi-daily consumption of 12 g portion of a high-flavanol milk chocolate containing approximately 35 mg of (-)-epicatechin for 2-weeks (14 days)
Low-flavanol milk chocolate	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)

Primary Outcome Measures

Name	Time	Method
Flow-mediated Dilation (FMD)	Change from baseline at 14 days	Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia

Secondary Outcome Measures

Name	Time	Method
Blood pressure (BP)	Change from baseline at 14 days	Acute assessment of systolic and diastolic BP (3 repeats)
Plasma Nitrite & Nitrate analysis	Change from baseline at 14 days	HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite \& Nitrate in plasma
Endothelial progenitor cells and Microparticles	Change from baseline at 14 days	Flow cytometric analysis using whole blood
Serum analysis of insulin	Change from baseline at 14 days	ELIZA kits for determination of insulin concentration in serum
Plasma flavanol metabolite analysis	Change from baseline at 14 days	HPLC-MS assessment of metabolite profile and content of plasma
Serum analysis of cardivascular-related blood marker(s) concentration	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
Executive Function	Change from baseline at 14 days	Assessed by cognitive test battery