Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)
The purpose of this study is to determine the effect of a slowly digesting starch on gut bacteria, sugar and fat metabolism, hunger hormones, and body fat in people with pre-diabetes.
|Study Design:||Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
|Official Title:||Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)|
- Insulin Sensitivity and Secretion [ Time Frame: 3 months ] [ Designated as safety issue: No ]Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
- Body Composition [ Time Frame: 3 months ] [ Designated as safety issue: No ]DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.
- Gut Microbiota [ Time Frame: 3 months ] [ Designated as safety issue: No ]Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
- Satiety [ Time Frame: 3 months ] [ Designated as safety issue: No ]Satiety hormones will be measured following ingestion of a standardized smoothie (Standard Meal Test). Satiety will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
- Hunger [ Time Frame: 3 months ] [ Designated as safety issue: No ]Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
|Study Start Date:||August 2012|
|Estimated Study Completion Date:||August 2017|
|Estimated Primary Completion Date:||August 2016 (Final data collection date for primary outcome measure)|
Placebo Comparator: Placebo Starch
Yogurt with about 45 g/day of placebo starch (amylopectin).
Dietary Supplement: Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Experimental: Experimental Starch
Yogurt with about 45 g/day of slowly digestible starch (amylose).
Dietary Supplement: Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
In a double blind randomized controlled clinical trial, the investigators will test the effect of slowly digesting starch (amylose) versus a placebo starch (amylopectin) on risk factors for type 2 diabetes. For the study, about 95 obese participants (ages 35-65) with pre-diabetes (impaired fasting glucose) will consume a yogurt containing about 45 g of either the experimental or placebo starch daily for 3 months. The investigators will test the hypothesis that, compared to controls, a daily intake of 45 g of amylose for 3 months will improve risk factors for the development of type 2 diabetes (insulin sensitivity and secretion) by decreasing ectopic fat depots and decreasing inflammation in parallel with a change in colonic microbial populations.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01708694
|United States, Louisiana|
|Pennington Biomedical Research Center||Recruiting|
|Baton Rouge, Louisiana, United States, 70808|
|Contact: recruiting 225-763-3000 email@example.com|
|Principal Investigator: Eric Ravussin, PhD|
|Sub-Investigator: Frank Greenway, MD|
|Sub-Investigator: Corby K. Martin, PhD|
|Sub-Investigator: Courtney M. Peterson, PhD|
|Sub-Investigator: Roy Martin, PhD|
|Sub-Investigator: Mike Keenan, PhD|
|Sub-Investigator: Kayanush Aryana, PhD|
|Sub-Investigator: Maria Marco, PhD|