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

This study is currently recruiting participants.

Verified May 2013 by Pennington Biomedical Research Center

Sponsor:

Information provided by (Responsible Party):

Eric Ravussin, Pennington Biomedical Research Center

ClinicalTrials.gov Identifier:

NCT01708694

First received: October 10, 2012

Last updated: May 28, 2013

Last verified: May 2013

History of Changes

Tracking Information
First Received Date ^ICMJE	October 10, 2012
Last Updated Date	May 28, 2013
Start Date ^ICMJE	August 2012
Estimated Primary Completion Date	August 2016 (final data collection date for primary outcome measure)
Current Primary Outcome Measures ^ICMJE (submitted: October 16, 2012)	Insulin Sensitivity and Secretion [ Time Frame: 3 months ] [ Designated as safety issue: No ] Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
Original Primary Outcome Measures ^ICMJE	Same as current
Change History	Complete list of historical versions of study NCT01708694 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures ^ICMJE (submitted: October 16, 2012)	Body Composition [ Time Frame: 3 months ] [ Designated as safety issue: No ] 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ] Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis. Satiety [ Time Frame: 3 months ] [ Designated as safety issue: No ] 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 [ Time Frame: 3 months ] [ Designated as safety issue: No ] Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Original Secondary Outcome Measures ^ICMJE	Same as current
Current Other Outcome Measures ^ICMJE	Not Provided
Original Other Outcome Measures ^ICMJE	Not Provided

Descriptive Information
Brief Title ^ICMJE	Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)
Official Title ^ICMJE	Role of Slowly Digesible Starch on Diabetes Risk Factors(STARCH)
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.
Study Type ^ICMJE	Interventional
Study Phase	Not Provided
Study Design ^ICMJE	Allocation: Randomized Intervention Model: Parallel Assignment Masking: Double Blind (Subject, Investigator)
Condition ^ICMJE	Prediabetes
Intervention ^ICMJE	Dietary Supplement: Amylose One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months. Dietary Supplement: Amylopectin The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Study Arm (s)	Placebo Comparator: Placebo Starch Yogurt with about 45 g/day of placebo starch (amylopectin). Intervention: Dietary Supplement: Amylose Experimental: Experimental Starch Yogurt with about 45 g/day of slowly digestible starch (amylose). Intervention: Dietary Supplement: Amylopectin
Publications *	Not Provided
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information
Recruitment Status ^ICMJE	Recruiting
Estimated Enrollment ^ICMJE	95
Estimated Completion Date	August 2017
Estimated Primary Completion Date	August 2016 (final data collection date for primary outcome measure)
Eligibility Criteria ^ICMJE	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.
Gender	Both
Ages	35 Years to 65 Years
Accepts Healthy Volunteers	No
Contacts ^ICMJE	Not Provided
Location Countries ^ICMJE	United States

Administrative Information
NCT Number ^ICMJE	NCT01708694
Other Study ID Numbers ^ICMJE	PBRC12009
Has Data Monitoring Committee	No
Responsible Party	Eric Ravussin, Pennington Biomedical Research Center
Study Sponsor ^ICMJE	Pennington Biomedical Research Center
Collaborators ^ICMJE	Not Provided
Investigators ^ICMJE	Not Provided
Information Provided By	Pennington Biomedical Research Center
Verification Date	May 2013
^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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