Trial | NCT01091922  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    cocoa bean ...

  • Study Participants

    22
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 Started
Jan 31
2008
Primary Completion
Dec 31
2009
Study Completion
Dec 31
2009
Last Update
Mar 24
2010
Estimate

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

Low Flavanol Placebo Comparator

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

High Flavanols Active Comparator

High Flavanol drink containing 495 mg of total flavanols

Criteria 

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.
No Results Posted