Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Glucose Metabolism Disorders
Hyperinsulinism
Metabolic Diseases

ClinicalTrials.gov processed this record on November 23, 2014