Role of Slowly Digesible Starch on Diabetes Risk Factors
NCT ID: NCT01708694
Last Updated: 2017-12-15
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
65 participants
INTERVENTIONAL
2012-08-31
2016-06-30
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
OTHER
DOUBLE
Study Groups
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Placebo Starch
Yogurt with about 45 g/day of placebo starch (amylopectin).
Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Experimental Starch
Yogurt with about 45 g/day of slowly digestible starch (amylose).
Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Interventions
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Amylose
One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.
Amylopectin
The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.
Eligibility Criteria
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Inclusion Criteria
* 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 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.
35 Years
65 Years
ALL
No
Sponsors
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National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
NIH
Pennington Biomedical Research Center
OTHER
Responsible Party
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Eric Ravussin
Principal Investigator
Locations
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Pennington Biomedical Research Center
Baton Rouge, Louisiana, United States
Countries
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References
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White U, Peterson CM, Beyl RA, Martin CK, Ravussin E. Resistant Starch Has No Effect on Appetite and Food Intake in Individuals with Prediabetes. J Acad Nutr Diet. 2020 Jun;120(6):1034-1041. doi: 10.1016/j.jand.2020.01.017. Epub 2020 Apr 9.
Peterson CM, Beyl RA, Marlatt KL, Martin CK, Aryana KJ, Marco ML, Martin RJ, Keenan MJ, Ravussin E. Effect of 12 wk of resistant starch supplementation on cardiometabolic risk factors in adults with prediabetes: a randomized controlled trial. Am J Clin Nutr. 2018 Sep 1;108(3):492-501. doi: 10.1093/ajcn/nqy121.
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.
Other Identifiers
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PBRC 12009
Identifier Type: -
Identifier Source: org_study_id