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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01091922
Enrollment
22
Registered
2010-03-24
Start date
2008-01-31
Completion date
2009-12-31
Last updated
2010-03-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Intestinal Bacteria Growth

Keywords

flavonoids, flavanols, bacteria

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.

Interventions

DIETARY_SUPPLEMENTLow flavanol cocoa beverage

23 mg of total flavanols from cocoa

DIETARY_SUPPLEMENTHigh flavanol cocoa beverage

495 mg of total flavanols from cocoa

Sponsors

University of Reading
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
DOUBLE (Subject, Investigator)

Eligibility

Sex/Gender
ALL
Age
18 Years to 50 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridizationbaseline and 4 weeksMeasurements 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

MeasureTime frame
Blood pressureBaseline, 4 weeks

Countries

United Kingdom

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 30, 2026