This trial is active, not recruiting.

Condition prediabetes
Treatments amylose, amylopectin
Sponsor Pennington Biomedical Research Center
Start date August 2012
End date August 2017
Trial size 95 participants
Trial identifier NCT01708694, PBRC 12009, R01DK092575


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.

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Intervention model parallel assignment
Masking double blind (subject, investigator)
(Placebo Comparator)
Yogurt with about 45 g/day of placebo starch (amylopectin).
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Yogurt with about 45 g/day of slowly digestible starch (amylose).
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Primary Outcomes

Insulin Sensitivity and Secretion
time frame: 3 months

Secondary Outcomes

Body Composition
time frame: 3 months
Gut Microbiota
time frame: 3 months
time frame: 3 months
time frame: 3 months

Eligibility Criteria

Male or female participants from 35 years up to 65 years old.

Inclusion Criteria - Have a body mass index between 30 and 44.9 kg/m2 - Are 35-65 years of age - Have pre-diabetes, which means impaired fasting glucose (IFG) - Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing - Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study - Are willing to maintain weight throughout the study Exclusion Criteria - Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer - Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL - Have an average screening blood pressure > 150/100 mm Hg - Are a pre-menopausal woman but do not have a regular menstrual cycle - Are pregnant or breastfeeding - Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents - Have emotional problems such as clinical depression or other diagnosed psychological conditions - Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study - Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study - Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal) - Chronically consume alcohol (> 4 servings per day) or actively smoke cigarettes (> 1/4 pack per day) - Are on any chronic medication that has not had a stable dose for 1 month or longer - Are required to perform of any kind of heavy physical activity - Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.

Additional Information

Official title Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
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.
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Pennington Biomedical Research Center.