NCT01708694

Role of Slowly Digesible Starch on Diabetes Risk Factors

Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 65 (actual)
• Sponsor: Pennington Biomedical Research Center · Academic / Other
• Sex: All
• Age: 35 Years – 65 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Prediabetes

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Amylose	One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
DIETARY_SUPPLEMENT	Amylopectin	The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Timeline

• Start date: 2012-08-01
• Primary completion: 2016-06-01
• Completion: 2016-06-01
• First posted: 2012-10-17
• Last updated: 2017-12-15

Locations

1 site across 1 country: United States