Insulin ResistancePhase 1NCT00668928
Effect of Dietary Polyphenols on Insulin Sensitivity
A Phase 1 study testing Polyphenols (flavon-3-ol monomers and oligomers) in people with Insulin Resistance, run by United States Department of Agriculture (USDA).
Trial summary
A large and growing segment of the population is prediabetic. Dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. Read more about this study
- Who is it for?
- Ages 25 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Polyphenols (flavon-3-ol monomers and oligomers)
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Jan 2006to Dec 2007
- Phase
- Phase 1
- 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 25 to 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005).
Who cannot join
- BMI < 27 kg/m²
- Age < 25 and > 65 years
- Pregnant women or women who plan on becoming pregnant during the study
- Postpartum women
- Lactating women
- Diabetes mellitus
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- Kidney disease
- Liver disease
- Certain cancers
- Smokers
About this study
A large and growing segment of the population is prediabetic. Dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity are likely to help maintain a healthier body composition. This pilot study will provide data to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.
Read the detailed description
How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?
- Conditions
- Insulin Resistance
- Being tested
- Polyphenols (flavon-3-ol monomers and oligomers)
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Polyphenols (flavon-3-ol monomers and oligomers)Other
Flavanols
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Apr 2008 (estimated)
- Study startJan 2006
- Primary completionDec 2007
- Study completionDec 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies 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 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- United States Department of Agriculture (USDA)
- Sponsor type
- US federal agency
- Investigators
- David J Baer, PhD, Principal investigator, ARS/USDA/BHNRC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00668928
- Sponsor's protocol ID
- 2005-252
- Status last verified
- Apr 2008
- First submitted
- 23 Apr 2008
- Last updated
- 29 Apr 2008
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Apr 2008. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Dietary Polyphenols on Insulin Sensitivity
- ClinicalTrials.gov ID
- NCT00668928
- Acronym / sponsor ID
- 2005-252
- Conditions
- Insulin Resistance
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- United States Department of Agriculture (USDA)US federal agency
- Study start
- Jan 2006
- Primary completion
- Dec 2007 (actual)
- Study completion
- Dec 2007 (actual)
- First posted
- 29 Apr 2008 (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.
A large and growing segment of the population is prediabetic. Dietary interventions that improve insulin sensitivity may be important in preventing the progression to full-blown diabetes in these individuals. Foods and dietary compounds that increase insulin sensitivity are likely to help maintain a healthier body composition. This pilot study will provide data to evaluate the role of dietary plant polyphenols in improving insulin sensitivity.
Detailed description
How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
Who may qualify
- Ages
- 25 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005).
Key exclusion criteria (10 listed)
- BMI < 27 kg/m²
- Age < 25 and > 65 years
- Pregnant women or women who plan on becoming pregnant during the study
- Postpartum women
- Lactating women
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 |
|---|---|---|
| Polyphenols (flavon-3-ol monomers and oligomers)Flavanols | Other | – |
Primary outcome
Not reported in the source record.
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 29 Apr 2008.
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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.
David J Baer, PhD principal investigator
ARS/USDA/BHNRC
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing Polyphenols (flavon-3-ol monomers and oligomers) in people with Insulin Resistance, run by United States Department of Agriculture (USDA).
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 1 inclusion and 10 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 29 Apr 2008. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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.
Where can I read the original study information?
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 29 Apr 2008.