The Impact of Dietary Flavanols on the Gut Microflora

University of Reading

Status: Completed

Conditions: Intestinal Bacteria Growth

Treatments: Dietary Supplement: High flavanol cocoa beverage; Dietary Supplement: Low flavanol cocoa beverage

Study type: Interventional

Funder types: Other

Identifiers

NCT01091922

UReading-2009-01

Details and patient eligibility

About

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

Full description

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.

Enrollment: 22 patients

Sex: All

Ages: 18 to 50 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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22 participants in 2 patient groups, including a placebo group

Low Flavanol

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Low flavanol cocoa beverage

High Flavanols

Active Comparator group

Description:

High Flavanol drink containing 495 mg of total flavanols

Treatment:

Dietary Supplement: High flavanol cocoa beverage