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

NCT ID: NCT02789761

Last Updated: 2016-06-03

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

34 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-01-31

Study Completion Date

2016-06-30

Brief Summary

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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

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Conditions

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Healthy

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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High-flavanol milk chocolate

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

Group Type ACTIVE_COMPARATOR

High-flavanol milk choocolate

Intervention Type DIETARY_SUPPLEMENT

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)

Group Type PLACEBO_COMPARATOR

Low-flavanol milk chocolate

Intervention Type DIETARY_SUPPLEMENT

Interventions

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High-flavanol milk choocolate

Intervention Type DIETARY_SUPPLEMENT

Low-flavanol milk chocolate

Intervention Type DIETARY_SUPPLEMENT

Other Intervention Names

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Epicatechin-rich milk chocolate

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

40 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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University of Reading

OTHER

Sponsor Role lead

Responsible Party

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Jeremy Paul Edward Spencer

Professor of Biochemistry

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Jeremy P Spencer, PhD

Role: PRINCIPAL_INVESTIGATOR

Univerisity of Reading

Other Identifiers

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MCStudy

Identifier Type: -

Identifier Source: org_study_id

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