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Effect of Dietary Polyphenols on Insulin Sensitivity

Primary Purpose

Insulin Resistance

Status

Completed

Phase

Phase 1

Locations

Study Type

Interventional

Intervention

Polyphenols (flavon-3-ol monomers and oligomers)

About this trial

This is an interventional treatment trial for Insulin Resistance

Eligibility Criteria

25 Years - 65 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

NCT ID

NCT00668928

First Posted

April 23, 2008

Last Updated

April 28, 2008

Sponsor

United States Department of Agriculture (USDA)

1. Study Identification

Unique Protocol Identification Number

NCT00668928

Brief Title

Effect of Dietary Polyphenols on Insulin Sensitivity

Official Title

Effect of Dietary Polyphenols on Insulin Sensitivity

Study Type

Interventional

2. Study Status

Record Verification Date

April 2008

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

December 2007 (Actual)

Study Completion Date

December 2007 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

United States Department of Agriculture (USDA)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

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?

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 1

Interventional Study Model

Crossover Assignment

Masking

ParticipantInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Intervention Type

Other

Intervention Name(s)

Polyphenols (flavon-3-ol monomers and oligomers)

Intervention Description

Flavanols

10. Eligibility

Sex

All

Minimum Age & Unit of Time

25 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

Eligibility 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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

David J Baer, PhD

Organizational Affiliation

ARS/USDA/BHNRC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Learn more about this trial

Effect of Dietary Polyphenols on Insulin Sensitivity

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