Ignite Creation Date:
2025-12-25 @ 3:00 AM
Ignite Modification Date:
2026-03-08 @ 4:11 AM
Study NCT ID:
NCT02380833
Status:
COMPLETED
Last Update Posted:
2016-11-17
First Post:
2015-02-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D015444', 'term': 'Exercise'}, {'id': 'D066046', 'term': 'Diet, Paleolithic'}], 'ancestors': [{'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2015-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-11', 'completionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2016-11-15', 'studyFirstSubmitDate': '2015-02-16', 'studyFirstSubmitQcDate': '2015-03-02', 'lastUpdatePostDateStruct': {'date': '2016-11-17', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-03-05', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-05', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in free living activity', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Armband activity monitor worn on the upper left arm (METs)'}, {'measure': 'Change in blood pressure', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Systolic and diastolic blood pressure'}, {'measure': 'Change in resting heart rate', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Beats per minute'}], 'primaryOutcomes': [{'measure': 'Change in aerobic conditioning', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Peak oxygen consumption'}, {'measure': 'Change in anaerobic power', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Wingate anaerobic threshold'}, {'measure': 'Change in strength', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Chest press and leg press estimated one repetition maximum'}], 'secondaryOutcomes': [{'measure': 'Change in resting energy expenditure', 'timeFrame': 'Baseline and 8 weeks', 'description': '24 hour kcal and respiratory quotient'}, {'measure': 'Change in urine', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Osmolality'}, {'measure': 'Change in insulin (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Radioimmunoprecipitation assay'}, {'measure': 'Change in glucagon (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Radioimmunoprecipitation assay'}, {'measure': 'Change in ghrelin (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Total and active ghrelin; Radioimmunoprecipitation assay'}, {'measure': 'Change in peptide YY 3-36 (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Radioimmunoprecipitation assay'}, {'measure': 'Change in adiponectin (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Radioimmunoprecipitation assay'}, {'measure': 'Change in leptin (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Radioimmunoprecipitation assay'}, {'measure': 'Change in tumor necrosis factor alpha (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'ELISA'}, {'measure': 'Change in interleukin 6 (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'ELISA'}, {'measure': 'Change in undercarboxylated osteocalcin (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'enzymeimmunoassay'}, {'measure': 'Change in total cholesterol (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in HDL cholesterol (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in non-HDL cholesterol (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Calculated from triacylglycerol, total cholesterol and HDL cholesterol'}, {'measure': 'Change in triacylglycerol (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in non-esterified fatty acids (plasma)', 'timeFrame': 'Baseline and weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in glucose (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in ketones (plasma)', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Colorimetric enzyme assay'}, {'measure': 'Change in fat mass', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Dual energy x-ray absorptiometry'}, {'measure': 'Change in fat free mass', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Dual energy x-ray absorptiometry'}, {'measure': 'Change in bone mass', 'timeFrame': 'Baseline and 8 weeks', 'description': 'Dual energy x-ray absorptiometry'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Healthy']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine the effectiveness of recommending either a Paleolithic based diet or the United States Department of Agriculture MyPlate guidelines with or without exercise on physical conditioning, hormones related to energy metabolism, body composition, resting energy expenditure, blood biomarkers, and urine in young, adult females.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* body fat percent between 20 and 38\n* less than 150 minutes of exercise per week at 4.5 or greater Metabolic Equivalent of Task\n* not pregnant, trying to become pregnant or lactating\n* non-smoker\n* no previous resistance training\n* have not been on a diet in the past three months\n* no dietary restrictions (food allergies, disease conditions, etc)\n* have not lost more than 10 lbs. in the past three months\n\nExclusion Criteria:\n\n* taking any medication\n* women who have had a left breast mastectomy\n* do not meet criteria of PAR-Q'}, 'identificationModule': {'nctId': 'NCT02380833', 'briefTitle': 'Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, in Women.', 'organization': {'class': 'OTHER', 'fullName': 'Clemson University'}, 'officialTitle': 'The Effectiveness of a Paleolithic Based Diet Compared to MyPlate Guidelines, With and Without Exercise, on Physical Conditioning in Women: a Randomized Controlled Trial.', 'orgStudyIdInfo': {'id': 'IRB2014-457'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'MyPlate', 'description': 'To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.', 'interventionNames': ['Behavioral: MyPlate']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'MyPlate + Exercise', 'description': 'To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.', 'interventionNames': ['Behavioral: MyPlate + Exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paleolithic', 'description': 'To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.', 'interventionNames': ['Behavioral: Paleolithic']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Paleolithic + Exercise', 'description': 'To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.', 'interventionNames': ['Behavioral: Paleolithic + Exercise']}], 'interventions': [{'name': 'MyPlate', 'type': 'BEHAVIORAL', 'description': 'To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations for eight weeks.', 'armGroupLabels': ['MyPlate']}, {'name': 'MyPlate + Exercise', 'type': 'BEHAVIORAL', 'description': 'To consume a weight maintenance diet based on the United States Department of Agriculture MyPlate nutrition recommendations and aerobic and resistance training four days per week for eight weeks.', 'armGroupLabels': ['MyPlate + Exercise']}, {'name': 'Paleolithic', 'type': 'BEHAVIORAL', 'description': 'To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations for eight weeks.', 'armGroupLabels': ['Paleolithic']}, {'name': 'Paleolithic + Exercise', 'type': 'BEHAVIORAL', 'description': 'To consume a weight maintenance diet based on alternative (Paleolithic based) nutrition recommendations and aerobic and resistance training four days per week for eight weeks.', 'armGroupLabels': ['Paleolithic + Exercise']}]}, 'contactsLocationsModule': {'locations': [{'zip': '29631', 'city': 'Clemson', 'state': 'South Carolina', 'country': 'United States', 'facility': 'Clemson University', 'geoPoint': {'lat': 34.68344, 'lon': -82.83737}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Clemson University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Assistant Professor', 'investigatorFullName': 'Elliot D. Jesch', 'investigatorAffiliation': 'Clemson University'}}}}