CClinicalTrials.gg
CompletedNCT00668928Updated Apr 29, 2008

Effect of Dietary Polyphenols on Insulin Sensitivity

A Phase 1 interventional study of Polyphenols (flavon-3-ol monomers and oligomers) in Insulin Resistance, sponsored by United States Department of Agriculture (USDA). Completed. Open to participants aged 25 Years to 65 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2008-04-29.

Sponsored by United States Department of Agriculture (USDA) · Phase 1, Interventional, and Treatment

Phase
Phase 1
Study type
Interventional
Enrollment
20
Allocation
Randomized
Ages
25 Years to 65 Years
Sex
All
01

Study 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.

Read the 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?

02

Conditions studied

  • Insulin Resistance

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03

In context

Insulin Resistance

1,960 studies on the registry are indexed under Insulin Resistance; 306 are open to participants now.

This study's enrollment of 20 is below the median of 40 across 1,536 interventional studies indexed under Insulin Resistance.

Browse Insulin Resistance studies →

Lead sponsor

United States Department of Agriculture (USDA) is the lead sponsor of 12 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
25 Years to 65 Years
Sexes eligible
All
Accepts healthy volunteers
Yes

Inclusion criteria

  • Individuals who are insulin resistant based on routine clinical measurements (Stern et al., 2005).

Exclusion criteria

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
05

Study design

Phase
Phase 1
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Crossover assignment
Masking
Double (Participant, Investigator)
Enrollment
20 participants (actual)

Interventions

  • OtherPolyphenols (flavon-3-ol monomers and oligomers)

    Flavanols

06

Study locations

No study locations are listed for this record.

07

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Apr 29, 2008, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
08

Registry details

Key details

Study ID
NCT00668928
Lead sponsor
United States Department of Agriculture (USDA)
First posted
Apr 29, 2008
Start date
Jan 2006
Primary completion
Dec 2007
Completion
Dec 2007
Last update
Apr 29, 2008

Study contacts

David J Baer, PhD
principal investigator · ARS/USDA/BHNRC

Oversight

Data monitoring committee
Yes
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Apr 2008. You cannot join it, but the record below documents what was studied.

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