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NCT00668928 Clinical Trial

Effect of Dietary Polyphenols on Insulin Sensitivity

Insulin Resistance Clinical Trial

Official title:
Effect of Dietary Polyphenols on Insulin Sensitivity

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00668928
Other study ID # 2005-252
Secondary ID
Status Completed
Phase Phase 1
First received April 23, 2008
Last updated April 28, 2008
Start date January 2006
Est. completion date December 2007

Study information
Verified date April 2008
Source USDA Beltsville Human Nutrition Research Center
Contact n/a
Is FDA regulated No
Health authority United States: Federal Government
Study type Interventional

Clinical 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. 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.

Description:

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

Recruitment information / eligibility
Status Completed
Enrollment 20
Est. completion date December 2007
Est. primary completion date December 2007
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 25 Years to 65 Years
Eligibility 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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

Intervention

Other:
• Polyphenols (flavon-3-ol monomers and oligomers)
Flavanols

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
United States Department of Agriculture (USDA)
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