The Impact of Dietary Flavanols on the Gut Microflora

N/ACompletedNCT01091922

University of Reading22 enrolled

Overview

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

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

BASIC_SCIENCE

Masking

DOUBLE

Enrollment

Conditions

Intestinal Bacteria Growth

Interventions

Low flavanol cocoa beverageDIETARY_SUPPLEMENT

23 mg of total flavanols from cocoa

High flavanol cocoa beverageDIETARY_SUPPLEMENT

495 mg of total flavanols from cocoa

Eligibility

Sex: ALLMin age: 18 YearsMax age: 50 YearsHealthy volunteers:

Medical Language ↔ Plain English

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.

Locations (1)

University of Reading

Reading, Berkshire, United Kingdom

Outcomes

Primary Outcomes

Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridization

Measurements of the growth rate and number of bacterial species in human faecal samples using 16S rRNA targeted oligonucleotide probes and fluorescence in situ hybridisation.

Time frame: baseline and 4 weeks

Secondary Outcomes

Blood pressure

Time frame: Baseline, 4 weeks

Data from ClinicalTrials.gov

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