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Effect of Dietary Polyphenols on Insulin Sensitivity

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00668928
First Posted: April 29, 2008
Last Update Posted: April 29, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
USDA Beltsville Human Nutrition Research Center
  Purpose
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 Intervention Phase
Insulin Resistance Other: Polyphenols (flavon-3-ol monomers and oligomers) Phase 1

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Dietary Polyphenols on Insulin Sensitivity

Resource links provided by NLM:


Further study details as provided by USDA Beltsville Human Nutrition Research Center:

Enrollment: 20
Study Start Date: January 2006
Study Completion Date: December 2007
Primary Completion Date: December 2007 (Final data collection date for primary outcome measure)
Intervention Details:
    Other: Polyphenols (flavon-3-ol monomers and oligomers)
    Flavanols
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?
  Eligibility

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
  Contacts and Locations
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
  More Information

Responsible Party: David J. Baer, ARS/USDA/BHNRC
ClinicalTrials.gov Identifier: NCT00668928     History of Changes
Other Study ID Numbers: 2005-252
First Submitted: April 23, 2008
First Posted: April 29, 2008
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