Role of Slowly Digesible Starch on Diabetes Risk Factors (STARCH)
|ClinicalTrials.gov Identifier: NCT01708694|
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : December 15, 2017
|Condition or disease||Intervention/treatment||Phase|
|Prediabetes||Dietary Supplement: Amylose Dietary Supplement: Amylopectin||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||65 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||Double (Participant, Investigator)|
|Official Title:||Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People|
|Study Start Date :||August 2012|
|Actual Primary Completion Date :||June 2016|
|Actual Study Completion Date :||June 2016|
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.
- Insulin Sensitivity and Secretion [ Time Frame: 3 months ]Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
- Body Composition [ Time Frame: 3 months ]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 ]Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
- Satiety [ Time Frame: 3 months ]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 ]Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01708694
|United States, Louisiana|
|Pennington Biomedical Research Center|
|Baton Rouge, Louisiana, United States, 70808|