Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Intestinal Bacteria Growth
- Sponsor
- University of Reading
- Enrollment
- 22
- Locations
- 1
- Primary Endpoint
- Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridization
- Status
- Completed
- Last Updated
- 16 years ago
Overview
Brief 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.
Investigators
Eligibility 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.
Outcomes
Primary Outcomes
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
- Blood pressure(Baseline, 4 weeks)