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

Healthy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT02789761
• Other study ID #: MCStudy
• Status: Active, not recruiting
• Phase: N/A
• First received: April 25, 2016
• Last updated: May 27, 2016
• Start date: January 2016
• Est. completion date: June 2016

Study information

• Verified date: May 2016
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 34
• Est. completion date: June 2016
• Est. primary completion date: June 2016
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 40 Years

Eligibility

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 Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Prevention

Related Conditions & MeSH terms

• Healthy

Intervention

Dietary Supplement:
• High-flavanol milk choocolate

• Low-flavanol milk chocolate

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Flow-mediated Dilation (FMD)	Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia	Change from baseline at 14 days	No
Secondary	Blood pressure (BP)	Acute assessment of systolic and diastolic BP (3 repeats)	Change from baseline at 14 days	No
Secondary	Executive Function	Assessed by cognitive test battery	Change from baseline at 14 days	No
Secondary	Endothelial progenitor cells and Microparticles	Flow cytometric analysis using whole blood	Change from baseline at 14 days	No
Secondary	Plasma flavanol metabolite analysis	HPLC-MS assessment of metabolite profile and content of plasma	Change from baseline at 14 days	No
Secondary	Plasma Nitrite & Nitrate analysis	HPLC-based system with inbuilt colorimetric Griess reaction assay for the assessment of Nitrite & Nitrate in plasma	Change from baseline at 14 days	No
Secondary	Serum analysis of cardivascular-related blood marker(s) concentration	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	No
Secondary	Serum analysis of insulin	ELIZA kits for determination of insulin concentration in serum	Change from baseline at 14 days	No