Ignite Creation Date:
2025-12-25 @ 1:40 AM
Ignite Modification Date:
2025-12-25 @ 11:55 PM
Study NCT ID:
NCT01708694
Status:
COMPLETED
Last Update Posted:
2017-12-15
First Post:
2012-10-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Role of Slowly Digesible Starch on Diabetes Risk Factors
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011236', 'term': 'Prediabetic State'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000688', 'term': 'Amylose'}, {'id': 'D000687', 'term': 'Amylopectin'}], 'ancestors': [{'id': 'D013213', 'term': 'Starch'}, {'id': 'D004040', 'term': 'Dietary Carbohydrates'}, {'id': 'D002241', 'term': 'Carbohydrates'}, {'id': 'D005936', 'term': 'Glucans'}, {'id': 'D011134', 'term': 'Polysaccharides'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-08'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-12', 'completionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-12-13', 'studyFirstSubmitDate': '2012-10-10', 'studyFirstSubmitQcDate': '2012-10-16', 'lastUpdatePostDateStruct': {'date': '2017-12-15', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2012-10-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin Sensitivity and Secretion', 'timeFrame': '3 months', 'description': 'Insulin sensitivity and secretion will be assessed via a Frequently Sampled Intravenous Glucose Tolerance Test (FSIGTT).'}], 'secondaryOutcomes': [{'measure': 'Body Composition', 'timeFrame': '3 months', 'description': 'DXA and MRS will be performed to measure body composition (adipose, muscle, bone mineral content) and to measure hepatic and intramyocellular lipids, respectively.'}, {'measure': 'Gut Microbiota', 'timeFrame': '3 months', 'description': 'Stool samples will be collected and fecal bacteria diversity will be measured in conjunction with metagenomic analysis.'}, {'measure': 'Satiety', 'timeFrame': '3 months', 'description': '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.'}, {'measure': 'Hunger', 'timeFrame': '3 months', 'description': 'Hunger will be measured through visual analogue scales (VAS), remote food photography, and a food intake test.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Prediabetes']}, 'referencesModule': {'references': [{'pmid': '32280055', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '30010698', 'type': 'DERIVED', 'citation': '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.'}, {'pmid': '29274892', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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.', 'detailedDescription': '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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria\n\n* Have a body mass index between 30 and 44.9 kg/m2\n* Are 35-65 years of age\n* Have pre-diabetes, which means impaired fasting glucose (IFG)\n* Are willing to complete nutritional and activity questionnaires and 2-3 weeks of baseline testing\n* Are willing to enroll in the 3-month intervention and maintain the same level of exercise during the study\n* Are willing to maintain weight throughout the study\n\nExclusion Criteria\n\n* Have evidence of cardiovascular disease, diabetes, symptomatic cholelithiasis (gallstones), or cancer\n* Have a fasting blood glucose less than 100 mg/dL or greater than 125 mg/dL\n* Have an average screening blood pressure \\> 150/100 mm Hg\n* Are a pre-menopausal woman but do not have a regular menstrual cycle\n* Are pregnant or breastfeeding\n* Chronically use medications including diuretics, steroids, and adrenergic-stimulating agents\n* Have emotional problems such as clinical depression or other diagnosed psychological conditions\n* Use hormonal contraceptives, oral or parenteral glucocorticoids, or any other medication known to influence glucose or insulin homeostasis (balance), within 1 month of study\n* Have a clinically significant gastrointestinal malabsorption syndrome, chronic diarrhea, or use antibiotics within one month of study\n* Have abnormal laboratory markers (e.g., elevated potassium levels, hemoglobin or hematocrit below the lower limit of normal)\n* Chronically consume alcohol (\\> 4 servings per day) or actively smoke cigarettes (\\> 1/4 pack per day)\n* Are on any chronic medication that has not had a stable dose for 1 month or longer\n* Are required to perform of any kind of heavy physical activity\n* Have metal objects in the body, such as a pacemaker, metal pins, bullet, etc.'}, 'identificationModule': {'nctId': 'NCT01708694', 'acronym': 'STARCH', 'briefTitle': 'Role of Slowly Digesible Starch on Diabetes Risk Factors', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Role of Slowly Digesible Starch on Diabetes Risk Factors In Pre-diabetic People', 'orgStudyIdInfo': {'id': 'PBRC 12009'}, 'secondaryIdInfos': [{'id': 'R01DK092575', 'link': 'https://reporter.nih.gov/quickSearch/R01DK092575', 'type': 'NIH'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Starch', 'description': 'Yogurt with about 45 g/day of placebo starch (amylopectin).', 'interventionNames': ['Dietary Supplement: Amylose']}, {'type': 'EXPERIMENTAL', 'label': 'Experimental Starch', 'description': 'Yogurt with about 45 g/day of slowly digestible starch (amylose).', 'interventionNames': ['Dietary Supplement: Amylopectin']}], 'interventions': [{'name': 'Amylose', 'type': 'DIETARY_SUPPLEMENT', 'description': 'One group of participants will consume a yogurt containing 45 g of amylose (the slowly digesting starch) for 3 months.', 'armGroupLabels': ['Placebo Starch']}, {'name': 'Amylopectin', 'type': 'DIETARY_SUPPLEMENT', 'description': 'The second group will consume a yogurt containing 45 g of a different starch called amylopectin (the "placebo") for 3 months.', 'armGroupLabels': ['Experimental Starch']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)', 'class': 'NIH'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Eric Ravussin', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}