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Effect of Dietary Polyphenols on Insulin Sensitivity

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ClinicalTrials.gov Identifier: NCT00668928
Recruitment Status : Completed
First Posted : April 29, 2008
Last Update Posted : April 29, 2008
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center

Brief 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.

Condition or disease Intervention/treatment Phase
Insulin Resistance Other: Polyphenols (flavon-3-ol monomers and oligomers) Phase 1

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 Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary Polyphenols on Insulin Sensitivity
Study Start Date : January 2006
Actual Primary Completion Date : December 2007
Actual Study Completion Date : December 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Allergy
Drug Information available for: Insulin
U.S. FDA Resources


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



Information from the National Library of Medicine

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Ages Eligible for Study:   25 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00668928


Sponsors and Collaborators
United States Department of Agriculture (USDA)
Investigators
Principal Investigator: David J Baer, PhD ARS/USDA/BHNRC

Responsible Party: David J. Baer, ARS/USDA/BHNRC
ClinicalTrials.gov Identifier: NCT00668928     History of Changes
Other Study ID Numbers: 2005-252
First Posted: April 29, 2008    Key Record Dates
Last Update Posted: April 29, 2008
Last Verified: April 2008

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs