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The Impact of Dietary Flavanols on the Gut Microflora

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01091922
Recruitment Status : Completed
First Posted : March 24, 2010
Last Update Posted : March 24, 2010
Sponsor:
Information provided by:
University of Reading

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.

Condition or disease Intervention/treatment Phase
Intestinal Bacteria Growth Dietary Supplement: Low flavanol cocoa beverage Dietary Supplement: High flavanol cocoa beverage Not Applicable

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 22 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Basic Science
Official Title: Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study
Study Start Date : January 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Arm Intervention/treatment
Placebo Comparator: Low Flavanol
Low flavanol drink containing 23 mg of total flavanols. Macro- and micro-nutrient matched with active comparator
Dietary Supplement: Low flavanol cocoa beverage
23 mg of total flavanols from cocoa

Active Comparator: High Flavanols
High Flavanol drink containing 495 mg of total flavanols
Dietary Supplement: High flavanol cocoa beverage
495 mg of total flavanols from cocoa




Primary Outcome Measures :
  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 Outcome Measures :
  1. Blood pressure [ Time Frame: Baseline, 4 weeks ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 50 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01091922


Locations
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United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG2 9AR
Sponsors and Collaborators
University of Reading
Investigators
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Principal Investigator: Jeremy Spencer, PhD University of Reading
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr Jeremy P E Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT01091922    
Other Study ID Numbers: UReading-2009-01
First Posted: March 24, 2010    Key Record Dates
Last Update Posted: March 24, 2010
Last Verified: March 2008
Keywords provided by University of Reading:
flavonoids
flavanols
bacteria