Role of Slowly Digesible Starch on Diabetes Risk Factors

Completed · Not applicable · Has a placebo group

Conditions studied: Prediabetes

In brief

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.

Key facts

Study ID

NCT01708694

Run by

Pennington Biomedical Research Center

People needed

65

Starts

2012-08-01

Expected to finish

2016-06-01

Last updated by the study team

2017-12-15

Who can join

Age: 35 and older, up to 65. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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.

Where it is running

• Pennington Biomedical Research Center — Baton Rouge, Louisiana, United States

Full record on ClinicalTrials.gov

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