Intestinal Bacteria GrowthNCT01091922
The Impact of Dietary Flavanols on the Gut Microflora
A study testing Low flavanol cocoa beverage and High flavanol cocoa beverage in people with Intestinal Bacteria Growth, run by University of Reading at 1 site in United Kingdom.
Trial summary
The primary propose of this study is to determine the impact of flavanol-rich cocoa on the growth of the human gut microbiota. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Intestinal Bacteria Growth
- What is being tested?
- Low flavanol cocoa beverage and High flavanol cocoa beverage
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 22 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Jan 2008to Dec 2009
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- a signed consent form
- age of 18-50 years inclusive
- BMI between 20-26
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study
The primary propose of this study is to determine the impact of flavanol-rich cocoa on the growth of the human gut microbiota.
Read the 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.
- Conditions
- Intestinal Bacteria Growth
- Being tested
- Low flavanol cocoa beverage, High flavanol cocoa beverage
- Keywords
- flavonoids, flavanols, bacteria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Low flavanol cocoa beverageDietary supplement
23 mg of total flavanols from cocoa
High flavanol cocoa beverageDietary supplement
495 mg of total flavanols from cocoa
| Study group | Role | What they receive |
|---|---|---|
| Low Flavanol | Placebo comparator | Low flavanol drink containing 23 mg of total flavanols. Macro- and micro-nutrient matched with active comparator Receives: Dietary Supplement: Low flavanol cocoa beverage |
| High Flavanols | Active comparator | High Flavanol drink containing 495 mg of total flavanols Receives: Dietary Supplement: High flavanol cocoa beverage |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline and 4 weeks
Secondary outcomes (1)
Blood pressure
Measured: Baseline, 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Mar 2010 (estimated)
- Study startJan 2008
- Primary completionDec 2009
- Study completionDec 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Intestinal Bacteria GrowthStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Investigators
- Jeremy Spencer, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01091922
- Sponsor's protocol ID
- UReading-2009-01
- Status last verified
- Mar 2008
- First submitted
- 23 Mar 2010
- Last updated
- 24 Mar 2010
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 21068351
Study at a glance
From the registry record, last updated by the sponsor on 24 Mar 2010. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prebiotic Evaluation of Cocoa-derived Flavanols in Healthy Humans Using a Randomized, Double Blind, Crossover, Placebo-controlled Intervention Study
- ClinicalTrials.gov ID
- NCT01091922
- Acronym / sponsor ID
- UReading-2009-01
- Conditions
- Intestinal Bacteria Growth
- Keywords
- flavonoids, flavanols, bacteria
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 22 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Jan 2008
- Primary completion
- Dec 2009 (actual)
- Study completion
- Dec 2009 (actual)
- First posted
- 24 Mar 2010 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Flavanol | Placebo comparator | Dietary Supplement: Low flavanol cocoa beverageLow flavanol drink containing 23 mg of total flavanols. Macro- and micro-nutrient matched with active comparator |
| High Flavanols | Active comparator | Dietary Supplement: High flavanol cocoa beverageHigh Flavanol drink containing 495 mg of total flavanols |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- a signed consent form
- age of 18-50 years inclusive
- BMI between 20-26
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Low flavanol cocoa beverage23 mg of total flavanols from cocoa | Dietary supplement | Low Flavanol |
| High flavanol cocoa beverage495 mg of total flavanols from cocoa | Dietary supplement | High Flavanols |
Primary outcome
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.
1 secondary outcome
Blood pressure
Time frame: Baseline, 4 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Mar 2010.
- Derived from this study: PubMed 21068351Tzounis 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeremy Spencer, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Low flavanol cocoa beverage and High flavanol cocoa beverage in people with Intestinal Bacteria Growth, run by University of Reading at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Mar 2010. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Faecal bacteria numbers using 16S rRNA targeted oligonucleotide probes analysis and fluorescence in situ hybridization (time frame: baseline and 4 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01091922, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Mar 2010.