The Impact of Dietary Flavanols on the Gut Microflora

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

COMPLETED

Clinical Phase

NA

Total Enrollment

22 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-01-31

Study Completion Date

2009-12-31

Brief Summary

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The primary propose of this study is to determine the impact of flavanol-rich cocoa on the growth of the human gut microbiota.

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Detailed Description

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A randomised, placebo-controlled, double-blind, cross-over human intervention study will be conducted in 20 healthy human volunteers to test the impact of a high-flavanol containing meal on the growth of the large intestinal bacteria (microflora). The high flavanol test meal will contain 495 mg of flavanols and the low flavanol control will contain 23 mg of flavanols. The two intervention diets are otherwise matched for macro- and micronutrient content. Changes in the gut microbiota will be determined by measuring bacterial population levels in human faecal material using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridization. A number of other biochemical and physiological measures will be recorded including blood glucose, lipoproteins, cytokine levels and blood pressure.

Conditions

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Intestinal Bacteria Growth

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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Low Flavanol

Low flavanol drink containing 23 mg of total flavanols. Macro- and micro-nutrient matched with active comparator

Group Type PLACEBO_COMPARATOR

Low flavanol cocoa beverage

Intervention Type DIETARY_SUPPLEMENT

23 mg of total flavanols from cocoa

High Flavanols

High Flavanol drink containing 495 mg of total flavanols

Group Type ACTIVE_COMPARATOR

High flavanol cocoa beverage

Intervention Type DIETARY_SUPPLEMENT

495 mg of total flavanols from cocoa

Interventions

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Low flavanol cocoa beverage

23 mg of total flavanols from cocoa

Intervention Type DIETARY_SUPPLEMENT

High flavanol cocoa beverage

495 mg of total flavanols from cocoa

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* a signed consent form
* age of 18-50 years inclusive
* BMI between 20-26

Exclusion Criteria

* pregnant or lactating
* allergy to milk products
* sensitivity to alkaloids and/or caffeine
* gastrointestinal disorders (e.g., chronic constipation, diarrhoea, inflammatory bowel disease, -inflammatory bowel syndrome, or other chronic gastrointestinal complaints)
* diabetes mellitus
* hypertension (\>150/90 mm/Hg)
* anaemia and gall bladder problems
* not consuming probiotics, prebiotics, antibiotics or anti-inflammatory or blood lowering medication within a 2-month period prior to the study.

Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes