Focus of the Study is Insulin Sensitivity Clinical Trial
Official title:
Effects of Dieatry Fiber on Insulin Sensitivity in Pre- and Post-menopausal Women
This study will examine the effects of a dietary fiber on insulin sensitivity in overweight and obese women. The fiber will be added to snack foods and women will consume the foods for four weeks. In one four-week period, 15 g of fiber will be added, and 30 g will added in another period. In a third period, no fiber will be added to the snack foods. Insulin senstivity will be measured at the end of each treatment period.
| Status | Unknown status |
| Enrollment | 40 |
| Est. completion date | September 2013 |
| Est. primary completion date | January 2012 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | Female |
| Age group | 19 Years to 70 Years |
| Eligibility |
Inclusion Criteria: - Impaired fasting glucose - Overweight and obese Exclusion Criteria: - Diabetes, Presence of chronic diseases |
| Country | Name | City | State |
|---|---|---|---|
| United States | Clinical Research Unit | Birmingham | Alabama |
| Lead Sponsor | Collaborator |
|---|---|
| Ingredion Incorporated |
United States,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Insulin sensitivity | A frequently sampled intravenous blood glucose tolerance test will be performed. | 5-hr test, performed 3 times within a 20-week period | |
| Secondary | Mitocondrial function | A muscle biospy will be taken to assess mitochondrial function | 3 times, with a 20-week period | |
| Secondary | Meal tolerance test | A high-fat meal will be given and blood will be drawn over a three-hr period | 3 times, within a 20-week period |