Prediabetes
Conditions
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.
Interventions
DIETARY_SUPPLEMENTAmylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
DIETARY_SUPPLEMENTAmylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the placebo) for 3 months.
Sponsors
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Pennington Biomedical Research Center
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
OTHER
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
35 Years to 65 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Insulin Sensitivity and Secretion | 3 months | Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT). |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Countries
United States
Outcome results
None listed