Effect of Dietary Polyphenols on Insulin Sensitivity

NCT ID: NCT00668928

Last Updated: 2008-04-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2006-01-31

Study Completion Date

2007-12-31

Brief Summary

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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

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How does the amount consumed of cocoa and tea polyphenols (flavon-3-ol monomers and oligomers) affect insulin sensitivity in insulin resistant individuals?

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Interventions

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Polyphenols (flavon-3-ol monomers and oligomers)

Flavanols

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005).

Exclusion Criteria

* 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
* Kidney disease
* Liver disease
* Certain cancers
* Smokers
Minimum Eligible Age

25 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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United States Department of Agriculture (USDA)

FED

Sponsor Role lead

Responsible Party

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ARS/USDA/BHNRC

Principal Investigators

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David J Baer, PhD

Role: PRINCIPAL_INVESTIGATOR

ARS/USDA/BHNRC

Other Identifiers

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2005-252

Identifier Type: -

Identifier Source: org_study_id