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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01708694
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : December 15, 2017
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center

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.

Condition or disease Intervention/treatment Phase
Prediabetes Dietary Supplement: Amylose Dietary Supplement: Amylopectin Not Applicable

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 : Interventional  (Clinical Trial)
Actual Enrollment : 65 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Official Title: Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
Study Start Date : August 2012
Actual Primary Completion Date : June 2016
Actual Study Completion Date : June 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Prediabetes
U.S. FDA Resources

Arm Intervention/treatment
Placebo Comparator: Placebo Starch
Yogurt with about 45 g/day of placebo starch (amylopectin).
Dietary Supplement: Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Experimental: Experimental Starch
Yogurt with about 45 g/day of slowly digestible starch (amylose).
Dietary Supplement: Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.

Primary Outcome Measures :
  1. Insulin Sensitivity and Secretion [ Time Frame: 3 months ]
    Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).

Secondary Outcome Measures :
  1. Body Composition [ Time Frame: 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.

  2. Gut Microbiota [ Time Frame: 3 months ]
    Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.

  3. Satiety [ Time Frame: 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.

  4. Hunger [ Time Frame: 3 months ]
    Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.

Information from the National Library of Medicine

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Ages Eligible for Study:   35 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01708694

United States, Louisiana
Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States, 70808
Sponsors and Collaborators
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Publications automatically indexed to this study by Identifier (NCT Number):
Responsible Party: Eric Ravussin, Principal Investigator, Pennington Biomedical Research Center Identifier: NCT01708694     History of Changes
Other Study ID Numbers: PBRC 12009
R01DK092575 ( U.S. NIH Grant/Contract )
First Posted: October 17, 2012    Key Record Dates
Last Update Posted: December 15, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Prediabetic State
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases