Role of Slowly Digesible Starch on Diabetes Risk Factors

Not Applicable

Completed

• Conditions: Prediabetes
• Interventions: Dietary Supplement: Amylopectin; Dietary Supplement: Amylose

• Registration Number: NCT01708694
• Lead Sponsor: Pennington Biomedical Research Center

Brief Summary

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.

Detailed Description

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.

Study Timeline

• Study Start: 2012-08
• Study First Submitted: 2012-10-10
• Study First Submitted QC: 2012-10-16
• Study First Posted: 2012-10-17
• Primary Completion: 2016-06
• Study Completion: 2016-06
• Status Verified: 2017-12
• Last Update Submitted: 2017-12-13
• Last Update Posted: 2017-12-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 65

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Experimental Starch	Amylopectin	Yogurt with about 45 g/day of slowly digestible starch (amylose).
Placebo Starch	Amylose	Yogurt with about 45 g/day of placebo starch (amylopectin).

Primary Outcome Measures

Name	Time	Method
Insulin Sensitivity and Secretion	3 months	Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).

Secondary Outcome Measures

Name	Time	Method
Body Composition	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	3 months	Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
Satiety	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	3 months	Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.

Trial Locations

Locations (1)

Pennington Biomedical Research Center; 🇺🇸 Baton Rouge, Louisiana, United States