NCT01091922

The Impact of Dietary Flavanols on the Gut Microflora

Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 22 (actual)
• Sponsor: University of Reading · Academic / Other
• Sex: All
• Age: 18 Years – 50 Years
• Healthy volunteers: Accepted

Summary

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

Detailed 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.

Conditions

• Intestinal Bacteria Growth

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Low flavanol cocoa beverage	23 mg of total flavanols from cocoa
DIETARY_SUPPLEMENT	High flavanol cocoa beverage	495 mg of total flavanols from cocoa

Timeline

• Start date: 2008-01-01
• Primary completion: 2009-12-01
• Completion: 2009-12-01
• First posted: 2010-03-24
• Last updated: 2010-03-24

Locations

1 site across 1 country: United Kingdom