Ignite Creation Date:
2025-12-25 @ 2:59 AM
Ignite Modification Date:
2026-03-03 @ 9:16 PM
Study NCT ID:
NCT01516333
Status:
COMPLETED
Last Update Posted:
2015-12-18
First Post:
2012-01-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Replace Glycemic Load and Satiety Study
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['PHASE1'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 26}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-12', 'completionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-12-17', 'studyFirstSubmitDate': '2012-01-19', 'studyFirstSubmitQcDate': '2012-01-19', 'lastUpdatePostDateStruct': {'date': '2015-12-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-01-24', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2007-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Glucose over time', 'timeFrame': '1 month', 'description': 'Blood glucose demonstrates that diets of different glycemic load result in measurable differences in serum glucose and insulin.'}], 'secondaryOutcomes': [{'measure': 'Visual Analog scores (VAS)', 'timeFrame': '1 month', 'description': 'Hunger, satiety, and vigor will be measured by the visual analog scales.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['glycemic Index'], 'conditions': ['Glucose Blood', 'Glycemic Index']}, 'referencesModule': {'references': [{'pmid': '22688548', 'type': 'DERIVED', 'citation': 'Liu AG, Most MM, Brashear MM, Johnson WD, Cefalu WT, Greenway FL. Reducing the glycemic index or carbohydrate content of mixed meals reduces postprandial glycemia and insulinemia over the entire day but does not affect satiety. Diabetes Care. 2012 Aug;35(8):1633-7. doi: 10.2337/dc12-0329. Epub 2012 Jun 11.'}]}, 'descriptionModule': {'briefSummary': 'The study is to examine the effect of four diets differing in glycemic index and amount of carbohydrate on blood sugar and insulin and in hunger, satiety, and vigor.', 'detailedDescription': 'The extent to which a food raises blood sugar after its consumption is ranked using the Glycemic Index (GI). Foods with a high GI are those taht cause a large and rapid rise in blood sugar while those with a low GI produce small fluctuations in blood sugar. It is believed that low GI foods are advantageous for health since the swings in blood sugar and insulin resistant or diabetic. Interestingly, some studies suggest that low GI food make you less hungry and that this may play an important role in body weight regulation.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass index between 25-35 kg/m2\n* Fasting serum glucose\n* Fasting serum glucose \\< 125 mg/dl\n* Free of chronic disease\n* Willing to eat only the foods that are provided by the Center during the diet periods\n* Willing to abstain from the consumption of alcohol during the diet periods\n* Regularly cycling and willing not to become pregnant using birth control (abstinence, barrier methods, partner surgically sterile\n* Monophasic birth control (same dose each day)\n* Hormone replacement therapy\n* Post-menopausal (over 1 year without bleeding)\n* Have had partial hysterectomy over the age of 55\n* complete hysterectomy at any age\n\nExclusion Criteria:\n\n* Documented presence of atherosclerotic disease\n* Diabetes mellitus\n* Renal, hepatic, endocrine, gastrointestinal, hematological or other systemic disease\n* Body Mass Index \\<25 or \\> 35\n* History of drug or alcohol abuse in the last year\n* For women, pregnancy, breast feeding or postpartum \\< 6 months\n* History of depression or mental illness requiring treatment or medication within that last 6 months\n* Multiple food allergies or significant food preferences or restrictions that would interfere with diet adherence\n* Lifestyle or schedule incompatible with the study protocol\n* Planned continued use of dietary supplements through the study trial\n* Smoking or tobacco use'}, 'identificationModule': {'nctId': 'NCT01516333', 'briefTitle': 'Replace Glycemic Load and Satiety Study', 'organization': {'class': 'OTHER', 'fullName': 'Pennington Biomedical Research Center'}, 'officialTitle': 'Response of Energy Peak Levels After Carbohydrates Are Eaten Glycemic Load and Satiety Study - Phase 1', 'orgStudyIdInfo': {'id': 'PBRC 26026'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Diet 1', 'description': 'High GI; High Carb; High GL', 'interventionNames': ['Other: High GL 107']}, {'type': 'EXPERIMENTAL', 'label': 'Diet 2', 'description': 'High GI, Low Carb, Med GL', 'interventionNames': ['Other: Medium GL 76']}, {'type': 'EXPERIMENTAL', 'label': 'Diet 3', 'description': 'Low GI, High Carb, Med GL', 'interventionNames': ['Other: Medium GL 68']}, {'type': 'EXPERIMENTAL', 'label': 'Diet 4', 'description': 'Low GI, Low Carb, Low GL', 'interventionNames': ['Other: Low GL 48']}], 'interventions': [{'name': 'High GL 107', 'type': 'OTHER', 'description': 'Three meals a day', 'armGroupLabels': ['Diet 1']}, {'name': 'Medium GL 76', 'type': 'OTHER', 'description': 'Three meals a day', 'armGroupLabels': ['Diet 2']}, {'name': 'Medium GL 68', 'type': 'OTHER', 'description': 'Three meals a day', 'armGroupLabels': ['Diet 3']}, {'name': 'Low GL 48', 'type': 'OTHER', 'description': 'Three meals a day', 'armGroupLabels': ['Diet 4']}]}, 'contactsLocationsModule': {'locations': [{'zip': '70808', 'city': 'Baton Rouge', 'state': 'Louisiana', 'country': 'United States', 'facility': 'Pennington Biomedical Research Center', 'geoPoint': {'lat': 30.44332, 'lon': -91.18747}}], 'overallOfficials': [{'name': 'Frank L Greenway, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}, {'name': 'William Cefalu, MD', 'role': 'STUDY_CHAIR', 'affiliation': 'Pennington Biomedial Research Center'}, {'name': 'Marlene M Most, PhD, RD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Pennington Biomedical Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pennington Biomedical Research Center', 'class': 'OTHER'}, 'collaborators': [{'name': 'General Mills', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Medial Principal Investigator', 'investigatorFullName': 'Frank Greenway', 'investigatorAffiliation': 'Pennington Biomedical Research Center'}}}}