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

Information source: Pennington Biomedical Research Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Prediabetes

Intervention: Amylose (Dietary Supplement); Amylopectin (Dietary Supplement)

Phase: N/A

Status: Recruiting

Sponsored by: Pennington Biomedical Research Center

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.

Clinical Details

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

Study design: Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator)

Primary outcome: Insulin Sensitivity and Secretion

Secondary outcome:

Body Composition

Gut Microbiota

Satiety

Hunger

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.

Eligibility

Minimum age: 35 Years. Maximum age: 65 Years. Gender(s): Both.

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.

Locations and Contacts

Pennington Biomedical Research Center, Baton Rouge, Louisiana 70808, United States; Recruiting
recruiting, Phone: 225-763-3000, Email: recruiters@pbrc.edu
Eric Ravussin, PhD, Principal Investigator
Frank Greenway, MD, Sub-Investigator
Corby K. Martin, PhD, Sub-Investigator
Courtney M. Peterson, PhD, Sub-Investigator
Roy Martin, PhD, Sub-Investigator
Mike Keenan, PhD, Sub-Investigator
Kayanush Aryana, PhD, Sub-Investigator
Maria Marco, PhD, Sub-Investigator
Additional Information

Starting date: August 2012
Last updated: August 8, 2014

Page last updated: August 23, 2015

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