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

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ClinicalTrials.gov Identifier: NCT01708694
Recruitment Status : Completed
First Posted : October 17, 2012
Last Update Posted : December 15, 2017
Sponsor:
Collaborator:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Information provided by (Responsible Party):
Eric Ravussin, Pennington Biomedical Research Center

October 10, 2012
October 17, 2012
December 15, 2017
August 2012
June 2016   (Final data collection date for primary outcome measure)
Insulin Sensitivity and Secretion [ Time Frame: 3 months ]
Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).
Same as current
Complete list of historical versions of study NCT01708694 on ClinicalTrials.gov Archive Site
  • 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.
  • Gut Microbiota [ Time Frame: 3 months ]
    Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
  • 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.
  • Hunger [ Time Frame: 3 months ]
    Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.
Same as current
Not Provided
Not Provided
 
Role of Slowly Digesible Starch on Diabetes Risk Factors
Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People
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.
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.
Interventional
Not Provided
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Other
Prediabetes
  • 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.
  • 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
Marlatt KL, White UA, Beyl RA, Peterson CM, Martin CK, Marco ML, Keenan MJ, Martin RJ, Aryana KJ, Ravussin E. Role of resistant starch on diabetes risk factors in people with prediabetes: Design, conduct, and baseline results of the STARCH trial. Contemp Clin Trials. 2018 Feb;65:99-108. doi: 10.1016/j.cct.2017.12.005. Epub 2017 Dec 21.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
65
June 2016
June 2016   (Final data collection date for primary outcome measure)

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.
Sexes Eligible for Study: All
35 Years to 65 Years   (Adult)
No
Contact information is only displayed when the study is recruiting subjects
United States
 
 
NCT01708694
PBRC 12009
R01DK092575 ( U.S. NIH Grant/Contract )
No
Not Provided
Not Provided
Eric Ravussin, Pennington Biomedical Research Center
Pennington Biomedical Research Center
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Not Provided
Pennington Biomedical Research Center
December 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP