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

NCT02789761 | Unknown

• 1 other identifier: MCStudy
• Study Type: interventional
• Target: 34
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Healthy

Keywords

Flow-mediated dilatation (FMD); Vascular function; cognitive function

Outcome Measures

Primary Outcomes (1)

• Flow-mediated Dilation (FMD)

  Ultrasound-based assessment of brachial artery reactivity following induced reactive hyperemia

  Change from baseline at 14 days

Secondary Outcomes (7)

• Blood pressure (BP)

  Change from baseline at 14 days

• Executive Function

  Change from baseline at 14 days

• Endothelial progenitor cells and Microparticles

  Change from baseline at 14 days

• Plasma flavanol metabolite analysis

  Change from baseline at 14 days

• Plasma Nitrite & Nitrate analysis

  Change from baseline at 14 days

Study Arms (2)

High-flavanol milk chocolate

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)

Dietary Supplement: High-flavanol milk choocolate

Low-flavanol 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)

Dietary Supplement: Low-flavanol milk chocolate

Interventions

High-flavanol milk choocolate DIETARY_SUPPLEMENT

Also known as: Epicatechin-rich milk chocolate

High-flavanol milk chocolate

Low-flavanol milk chocolate DIETARY_SUPPLEMENT

Low-flavanol milk chocolate

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Reading: lead

Study Officials

• Jeremy P Spencer, PhD

  Univerisity of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor of Biochemistry

Study Record Dates

• First Submitted: April 25, 2016
• First Posted: June 3, 2016
• Study Start: January 1, 2016
• Primary Completion: June 1, 2016
• Study Completion: June 1, 2016
• Last Updated: June 3, 2016

Record last verified: 2016-05

Data Sharing

• IPD Sharing: Will not share