Effect of Dietary Polyphenols on Insulin Sensitivity

This study has been completed.
Sponsor:
Information provided by:
USDA Beltsville Human Nutrition Research Center
ClinicalTrials.gov Identifier:
NCT00668928
First received: April 23, 2008
Last updated: April 28, 2008
Last verified: April 2008
  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 Blind (Subject, 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

Ages Eligible for Study:   25 Years to 65 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00668928

Sponsors and Collaborators
USDA Beltsville Human Nutrition Research Center
Investigators
Principal Investigator: David J Baer, PhD ARS/USDA/BHNRC
  More Information

No publications provided

Responsible Party: David J. Baer, ARS/USDA/BHNRC
ClinicalTrials.gov Identifier: NCT00668928     History of Changes
Other Study ID Numbers: 2005-252
Study First Received: April 23, 2008
Last Updated: April 28, 2008
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases

ClinicalTrials.gov processed this record on April 17, 2014