Ignite Creation Date:
2025-12-25 @ 2:39 AM
Ignite Modification Date:
2025-12-27 @ 11:00 PM
Study NCT ID:
NCT01622634
Status:
COMPLETED
Last Update Posted:
2015-09-25
First Post:
2012-06-15
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'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': 'D000072696', 'term': 'High-Intensity Interval Training'}], 'ancestors': [{'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'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': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 49}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-02'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-09', 'completionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-09-24', 'studyFirstSubmitDate': '2012-06-15', 'studyFirstSubmitQcDate': '2012-06-15', 'lastUpdatePostDateStruct': {'date': '2015-09-25', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-06-19', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-03', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic Syndrome Risk Factors', 'timeFrame': 'Change [Baseline to 6 Weeks]', 'description': '1. Post-Prandial Lipemia (and/or metabolic responses including insulin, glucose, triglycerides and free-fatty acids) to: a) a high fat meal challenge and b) a meal challenge similar to the higher protein or carbohydrate treatment arm. After an overnight fast and baseline blood draws, participants will consume a small meal and have their blood sampled every 30 minutes for 3 hours.\n2. Biomarkers for Cardiovascular Disease and Diabetes Mellitus. Fasting blood samples for serum lipids, glucose, insulin and systemic inflammation (C-reactive protein) will be taken after an overnight fast.'}], 'secondaryOutcomes': [{'measure': 'Satiety', 'timeFrame': 'Change [Baseline to 6 weeks]', 'description': 'Satiety will be assessed using questionnaires'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['cardiovascular disease', 'diabetes mellitus'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The objective of this study is to determine the combined effects of a high-protein diet and high-intensity training on metabolic syndrome risk factors in women aged 30-65.', 'detailedDescription': 'High-protein diet interventions have been shown to be effective in reducing triglycerides and increasing high-density lipoprotein cholesterol concentrations. Low-volume, high-intensity cycling exercise has shown to elicit positive effects on metabolic syndrome risk factors such as triglyceride concentrations. The objective of this study was to determine the combined effects of a high-protein, reduced carbohydrate diet and high-intensity interval training on metabolic syndrome risk factors in women. The second primary aim is to investigate the effect of the macronutrient content of the post-exercise meal consumed following an acute bout of interval training on postprandial metabolism.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Women aged 30-65 yrs of age, inclusive\n* Waist circumference \\> 88 cm.\n* Weight stable (within 2 kg) for past 6 mo\n* Sedentary/Low-active (defined as \\<300minutes/wk light or moderate activity, with no vigorous activity in last 6 months)\n* At risk for MetS \\[defined as having 2 of the following 4 factors: 1) hypertriglyceridemia defined as \\> 150 mg/mL, 2) low HDL cholesterol defined \\< 50 or on medication, 3) elevated blood pressure defined as \\> 130/\\>85 Hg or taking medications or 4) hyperglycemia defined as fasting blood glucose \\> 100 or glycated hemoglobin \\> 6.5 or taking medications.\n* Willing to be randomized to the four treatment groups\n\nExclusion Criteria:\n\n* Any chronic disease/condition that would not permit exercise or dietary restriction (including egg allergy or refusal to incorporate eggs into the diet) or alter interpretation of data. Examples include, but are not limited to:\n\n 1. cardiopulmonary disease (e.g. recent myocardial infarction, unstable angina, stroke) or unstable disease; 2) severe orthopedic, musculoskeletal or neuromuscular impairments that would contradict exercise; 3) sensory impairments that interfere with following directions; 4) diagnosis of dementia; 5) history of malignancy during the past 5 yr; 6) medication use that impacts primary outcomes of interest (e.g. statins); 7) weight greater than 400 pounds due to DXA weight and size limitations; 8) Uncontrolled blood pressure defined as \\> 160/\\>100 Hg.'}, 'identificationModule': {'nctId': 'NCT01622634', 'acronym': 'EPHIT', 'briefTitle': 'Effect of a High-Protein Diet and/or High-Intensity Training on Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Georgia'}, 'officialTitle': 'The E-PHIT Study: Eggs, Protein, and High-Intensity Training: A Diabetes Prevention Program for Women', 'orgStudyIdInfo': {'id': 'EPHIT'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Higher Protein Diet (PRO)', 'interventionNames': ['Other: Higher PRO Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Higher Carbohydrate Diet (CARB)', 'interventionNames': ['Other: Higher CARB Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'PRO & Interval Exercise (PRO+EX)', 'interventionNames': ['Behavioral: Sprint Interval Exercise', 'Other: Higher PRO Diet']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'CARB & Interval Exercise (CARB+EX)', 'interventionNames': ['Behavioral: Sprint Interval Exercise', 'Other: Higher CARB Diet']}], 'interventions': [{'name': 'Sprint Interval Exercise', 'type': 'BEHAVIORAL', 'otherNames': ['High Intensity Training', 'Sprint Interval Cycling'], 'description': 'Participants will undergo sprint interval training on a cycle ergometer 3 times weekly for 6 weeks. Each training session begins with a 5-minute active warm-up. The warm-up is followed by 4-7 bouts of 30 seconds of all-out sprints and 4 minutes of active recovery.', 'armGroupLabels': ['CARB & Interval Exercise (CARB+EX)', 'PRO & Interval Exercise (PRO+EX)']}, {'name': 'Higher PRO Diet', 'type': 'OTHER', 'otherNames': ['Higher Protein Reduced Carbohydrate Diet'], 'description': 'Participants in the PRO and PRO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the high protein diet.', 'armGroupLabels': ['Higher Protein Diet (PRO)', 'PRO & Interval Exercise (PRO+EX)']}, {'name': 'Higher CARB Diet', 'type': 'OTHER', 'otherNames': ['Conventional Higher Carbohydrate Diet'], 'description': 'Participants in the CHO and CHO+EX groups will meet weekly with a diet specialist on staff to monitor their intake and compliance with the higher carbohydrate diet.', 'armGroupLabels': ['CARB & Interval Exercise (CARB+EX)', 'Higher Carbohydrate Diet (CARB)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '30602', 'city': 'Athens', 'state': 'Georgia', 'country': 'United States', 'facility': 'Body Composition and Metabolism Lab, Ramsey Center, University of Georgia', 'geoPoint': {'lat': 33.96095, 'lon': -83.37794}}], 'overallOfficials': [{'name': 'Ellen M. Evans, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}, {'name': 'Kirk J. Cureton, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Georgia'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Georgia', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Principal Investigator', 'investigatorFullName': 'Ellen Evans', 'investigatorAffiliation': 'University of Georgia'}}}}