Ignite Creation Date:
2025-12-25 @ 1:03 AM
Ignite Modification Date:
2025-12-25 @ 11:16 PM
Study NCT ID:
NCT01186393
Status:
COMPLETED
Last Update Posted:
2015-05-18
First Post:
2010-08-19
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
STUDY: Effects of Potatoes in a Weight Loss Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 90}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2007-05'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2014-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-14', 'studyFirstSubmitDate': '2010-08-19', 'studyFirstSubmitQcDate': '2010-08-19', 'lastUpdatePostDateStruct': {'date': '2015-05-18', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-08-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Weight Loss', 'timeFrame': '12 Weeks'}], 'secondaryOutcomes': [{'measure': 'Glucose tolerance', 'timeFrame': '12 Weeks'}, {'measure': 'Body composition', 'timeFrame': '12 weeks'}, {'measure': 'Blood Pressure', 'timeFrame': '12 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Weight Loss', 'Potatoes', 'Dietary Meetings', 'Glycemic Control'], 'conditions': ['Obesity']}, 'referencesModule': {'references': [{'pmid': '25302575', 'type': 'RESULT', 'citation': 'Randolph JM, Edirisinghe I, Masoni AM, Kappagoda T, Burton-Freeman B. Potatoes, glycemic index, and weight loss in free-living individuals: practical implications. J Am Coll Nutr. 2014;33(5):375-84. doi: 10.1080/07315724.2013.875441. Epub 2014 Oct 10.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to test whether diets that contain potatoes and differ in glycemic index/load will be useful in weight loss, blood sugar control and maintaining current body weight.', 'detailedDescription': 'The study will examine the effect of including potatoes as part of a calorie restricted diet designed to induce weight loss and improve glycemic control in overweight subjects.\n\nThis is a randomized, treatment-controlled, 3-arm, parallel study. The 3 arms of the study will include dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Two diets will be energy-restricted (\\~ 500 kcal deficit /d) for weight loss and the control diet will be prescribed for weight maintenance. The two energy-restricted diets will include further manipulation, such that, one dietary plan will be a high glycemic index (GI) diet and the other a low glycemic index diet.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Men and women\n* ≥ 18 years of age who have a body mass index (BMI) of 25 to 35 kg/m2 (inclusive).\n\nExclusion Criteria:\n\n* Total cholesterol (TC) not greater than 300 mg/dL,\n* Fasting triglyceride not greater than 300 mg/dL ,\n* LDL cholesterol (LDL-C) not greater than 180 mg/dL,\n* Smokers\n* Female subjects who are pregnant or lactating\n* Subjects taking any medications that would interfere with outcomes of the study\n* Subjects with unusual dietary habits (eg., pica)\n* Subjects who are actively losing weight or trying to lose weight\n* Subjects who are addicted to drugs or alcohol or who are \\< 1 y in recovery program\n* Subjects who present with significant psychiatric or neurological disturbances\n* Subjects with known allergy or intolerance to potato products\n* Subjects with documented atherosclerotic disease, inflammatory disease, diabetes mellitus, uncontrolled hypertension ( 140/90 mm Hg), chronic lung, renal or liver disease'}, 'identificationModule': {'nctId': 'NCT01186393', 'acronym': 'BBFUSPB', 'briefTitle': 'STUDY: Effects of Potatoes in a Weight Loss Program', 'organization': {'class': 'OTHER', 'fullName': 'University of California, Davis'}, 'officialTitle': 'CCRC: Assessing the Role of Glycemic Index in Body Weight Management and Glucose Control', 'orgStudyIdInfo': {'id': '200715352'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Control', 'description': 'Arm includes dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). Control diet will be prescribed for weight maintenance.', 'interventionNames': ['Behavioral: Control']}, {'type': 'EXPERIMENTAL', 'label': 'Low Glycemic Index', 'description': 'Diets will be energy-restricted (\\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.', 'interventionNames': ['Behavioral: Low Glycemic Index']}, {'type': 'EXPERIMENTAL', 'label': 'High Glycemic Index', 'description': 'Diets will be energy-restricted (\\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on High Glycemic Index foods.', 'interventionNames': ['Behavioral: High Glycemic Index']}], 'interventions': [{'name': 'Control', 'type': 'BEHAVIORAL', 'otherNames': ['No energy reduction'], 'description': 'Dietary manipulation in the free-living setting to include potatoes/potato products frequently in the diet (5-7 days / week). The control diet will be prescribed for weight maintenance.', 'armGroupLabels': ['Control']}, {'name': 'Low Glycemic Index', 'type': 'BEHAVIORAL', 'otherNames': ['Low glycemic index reduced energy'], 'description': 'Diets will be energy-restricted (\\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.', 'armGroupLabels': ['Low Glycemic Index']}, {'name': 'High Glycemic Index', 'type': 'BEHAVIORAL', 'otherNames': ['High glycemic index reduced energy'], 'description': 'Diets will be energy-restricted (\\~ 500 kcal deficit /d) for weight loss, will include consumption of 5-7 potatoes/week, and will focus on Low Glycemic Index foods.', 'armGroupLabels': ['High Glycemic Index']}]}, 'contactsLocationsModule': {'locations': [{'zip': '95616', 'city': 'Davis', 'state': 'California', 'country': 'United States', 'facility': 'University of California Davis (Academic Surge, Ragle Human Nutrition Research Facility)', 'geoPoint': {'lat': 38.54491, 'lon': -121.74052}}, {'zip': '95655', 'city': 'Mather', 'state': 'California', 'country': 'United States', 'facility': 'VA Hospital, Mather', 'geoPoint': {'lat': 37.88215, 'lon': -119.85573}}], 'overallOfficials': [{'name': 'Britt Burton-Freeman, Ph.D', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}, {'name': 'C. Tissa Kappagoda, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of California, Davis'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of California, Davis', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}