Role of Slowly Digesible Starch on Diabetes Risk Factors (STARCH)

Pennington Biomedical Research Center

Status

Completed

Conditions

Prediabetes

Treatments

Dietary Supplement: Amylose

Dietary Supplement: Amylopectin

Study type

Interventional

Funder types

Other

NIH

Identifiers

NCT01708694

PBRC 12009

R01DK092575 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

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.

Full 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.

Enrollment

65 patients

Sex

All

Ages

35 to 65 years old

Volunteers

No Healthy Volunteers

Inclusion and exclusion criteria

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.