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Completed

NCT Number: NCT01091922

The Impact of Dietary Flavanols on the Gut Microflora

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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Key information

Age range

18 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG2 9AR, United Kingdom

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Low flavanol cocoa beverage

Dietary Supplement

23 mg of total flavanols from cocoa

High flavanol cocoa beverage

Dietary Supplement

495 mg of total flavanols from cocoa

Primary outcomes

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

    Time frame: baseline and 4 weeks

    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.

Secondary outcomes

  1. Blood pressure

    Time frame: Baseline, 4 weeks

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Mar 24, 2010
Registry last updated
Mar 24, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.