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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK092575 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo Starch | Placebo Comparator | Yogurt with about 45 g/day of placebo starch (amylopectin). |
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| Experimental Starch | Experimental | Yogurt with about 45 g/day of slowly digestible starch (amylose). |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Amylose | Dietary Supplement | One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months. |
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| Measure | Description | Time Frame |
|---|---|---|
| Insulin Sensitivity and Secretion | Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT). | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Body Composition | DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively. | 3 months |
| Gut Microbiota |
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Inclusion Criteria
Exclusion Criteria
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Pennington Biomedical Research Center | Baton Rouge | Louisiana | 70808 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32280055 | Derived | 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. | |
| 30010698 | Derived | 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. |
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| ID | Term |
|---|---|
| D011236 | Prediabetic State |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000688 | Amylose |
| D000687 | Amylopectin |
| ID | Term |
|---|---|
| D013213 | Starch |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005936 | Glucans |
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| Amylopectin | Dietary Supplement | The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months. |
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Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.
| 3 months |
| Satiety | 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. | 3 months |
| Hunger | Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test. | 3 months |
| 29274892 | Derived | 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. |
| D004700 | Endocrine System Diseases |
| D011134 |
| Polysaccharides |