Ignite Creation Date:
2025-12-24 @ 3:49 PM
Ignite Modification Date:
2026-01-05 @ 2:22 AM
Study NCT ID:
NCT03093792
Status:
COMPLETED
Last Update Posted:
2017-03-28
First Post:
2017-03-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Diet Manipulation on Women in the Curves Program
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000572', 'term': 'American Heart Association'}, {'id': 'D015444', 'term': 'Exercise'}], 'ancestors': [{'id': 'D014837', 'term': 'Voluntary Health Agencies'}, {'id': 'D009939', 'term': 'Organizations, Nonprofit'}, {'id': 'D009938', 'term': 'Organizations'}, {'id': 'D004472', 'term': 'Health Care Economics and Organizations'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 86}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-09-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-03', 'completionDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-03-22', 'studyFirstSubmitDate': '2017-03-22', 'studyFirstSubmitQcDate': '2017-03-22', 'lastUpdatePostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-03-28', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Effects of the Curves program on physical activity patterns', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on body weight', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on the hip/waist ratio', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on Resting Energy Expenditure (REE)', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on Blood Pressure (BP)', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on Heart Rate (HR)', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on body composition (DXA)', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on Bioelectrical Impedance Analysis (BIA)', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on a chemistry-15 blood panel', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on a cell blood count (CBC) blood panel', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on lipid panels', 'timeFrame': '24 weeks'}], 'secondaryOutcomes': [{'measure': 'Effects of the Curves program on maximal cardiopulmonary capacity', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on muscular strength through a 1 repetition maximum (1 RM) test', 'timeFrame': '24 weeks'}, {'measure': 'Effects of the Curves program on muscular endurance through a maximal repetition test', 'timeFrame': '24 weeks'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Diet, Carbohydrate-Restricted']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to look at the effects of a carbohydrate restricted, high protein, high fat diet on weight loss and health outcomes in women participating in the Curves Fitness and Weight Loss Program.', 'detailedDescription': 'The purpose of this study is to determine if a carbohydrate restricted, high protein, high fat diet (20% carbohydrate, 45% protein, 35% fat; CC-II) promotes more favorable changes in weight loss and health outcomes compared to a traditional high carbohydrate, low protein, low fat diet (55% carbohydrate, 15% protein, 30% fat; AHA) and the Curves moderate carbohydrate restricted, high protein, and low fat diet (30% carbohydrate, 45% protein, 25% fat; CC-I).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'The eligibility criteria were at the request of the study sponsor.', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* The participant is an apparently healthy female\n* The participant is between the ages of 18 and 60\n\nExclusion Criteria:\n\n* The participant is pregnant or nursing, or plans to become pregnant during the next 12 months or has been pregnant in the past 12 months\n* The participant has uncontrolled metabolic disorder including known electrolyte abnormalities; heart disease, arrhythmias, diabetes, thyroid disease, or hypogonadism; a history of hypertension, hepatorenal, musculoskeletal, autoimmune, or neurological disease\n* The participant is currently taking thyroid, hyperlipidemic, hypoglycemic, anti-hypertensive, or androgenic medications\n* The participant has taken ergogenic levels of nutritional supplements that may affect muscle mass (e.g., creatine, HMB), anabolic/catabolic hormone levels (androstenedione, DHEA, etc.) or weight loss (e.g., ephedra, thermogenics, etc.) within the past three months\n* The participant is willing to participate in a regular moderate exercise program'}, 'identificationModule': {'nctId': 'NCT03093792', 'acronym': 'Curves2', 'briefTitle': 'Effects of Diet Manipulation on Women in the Curves Program', 'organization': {'class': 'OTHER', 'fullName': 'Texas A&M University'}, 'officialTitle': 'Effects of a Carbohydrate Restricted, High Protein, High Fat Diet on Weight Loss and Health Outcomes in Women Participating in the Curves Fitness and Weight Loss Program', 'orgStudyIdInfo': {'id': 'IRB2013-0495FX'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Control', 'description': '(no diet or exercise intervention)', 'interventionNames': ['Other: Control']}, {'type': 'EXPERIMENTAL', 'label': 'American Heart Association', 'description': '(AHA: 55% carbohydrate, 15% protein, 30% fat - diet plus exercise)', 'interventionNames': ['Other: American Heart Association plus exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Curves Complete - I', 'description': '(CC - I: 30% carbohydrate, 45% protein, 25% fat - diet plus exercise)', 'interventionNames': ['Other: Curves Complete - I plus exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Curves Complete - II', 'description': '(CC - II: 20% carbohydrate, 45% protein, 35% fat - diet plus exercise)', 'interventionNames': ['Other: Curves Complete - II plus exercise']}], 'interventions': [{'name': 'Control', 'type': 'OTHER', 'armGroupLabels': ['Control']}, {'name': 'American Heart Association plus exercise', 'type': 'OTHER', 'armGroupLabels': ['American Heart Association']}, {'name': 'Curves Complete - I plus exercise', 'type': 'OTHER', 'armGroupLabels': ['Curves Complete - I']}, {'name': 'Curves Complete - II plus exercise', 'type': 'OTHER', 'armGroupLabels': ['Curves Complete - II']}]}, 'contactsLocationsModule': {'overallOfficials': [{'name': 'Richard B Kreider, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Texas A&M University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Texas A&M University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Curves International', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}