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

University of Reading

Status: Unknown

Conditions: Healthy

Treatments: Dietary Supplement: Low-flavanol milk chocolate; Dietary Supplement: High-flavanol milk choocolate

Study type: Interventional

Funder types: Other

Identifiers

NCT02789761

MCStudy

Details and patient eligibility

About

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.

Enrollment: 34 patients

Sex: Male

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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34 participants in 2 patient groups, including a placebo group

High-flavanol milk chocolate

Active Comparator group

Description:

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

Treatment:

Dietary Supplement: High-flavanol milk choocolate

Low-flavanol milk chocolate

Placebo Comparator group

Description:

Bi-daily consumption of 12 g portion of a low-flavanol milk chocolate containing approximately \<1 mg of (-)-epicatechin for 2-weeks (14 days)

Treatment:

Dietary Supplement: Low-flavanol milk chocolate