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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Low flavanol cocoa beverage | Dietary Supplement | 23 mg of total flavanols from cocoa |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridization | 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. | baseline and 4 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Blood pressure | Baseline, 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Jeremy Spencer, PhD | University of Reading | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Reading | Reading | Berkshire | RG2 9AR | United Kingdom |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 21068351 | Derived | Tzounis X, Rodriguez-Mateos A, Vulevic J, Gibson GR, Kwik-Uribe C, Spencer JP. Prebiotic evaluation of cocoa-derived flavanols in healthy humans by using a randomized, controlled, double-blind, crossover intervention study. Am J Clin Nutr. 2011 Jan;93(1):62-72. doi: 10.3945/ajcn.110.000075. Epub 2010 Nov 10. |
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| High flavanol cocoa beverage |
| Dietary Supplement |
495 mg of total flavanols from cocoa |
|