Ignite Creation Date:
2025-12-25 @ 2:49 AM
Ignite Modification Date:
2025-12-30 @ 2:16 PM
Study NCT ID:
NCT00800033
Status:
COMPLETED
Last Update Posted:
2015-05-27
First Post:
2008-11-26
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D024821', 'term': 'Metabolic Syndrome'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE3'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 87}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2008-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-05', 'completionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-05-26', 'studyFirstSubmitDate': '2008-11-26', 'studyFirstSubmitQcDate': '2008-11-28', 'lastUpdatePostDateStruct': {'date': '2015-05-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2008-12-01', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2010-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Metabolic syndrome score', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}], 'secondaryOutcomes': [{'measure': 'Plasma glucose', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Plasma insulin', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'High density lipoproteins', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Triacylglycerol', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Waist circumference', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'C-reactive protein', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Lean body mass', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Fat mass', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Whole body bone mineral', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Hip bone mineral', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Lumbar spine bone mineral', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Low density lipoproteins', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Total cholesterol', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Blood Pressure', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Aerobic fitness - modified Canadian Test of Fitness', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}, {'measure': 'Strength', 'timeFrame': 'baseline, 2 months, 3 months, 5 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['metabolic syndrome', 'lipids', 'blood pressure', 'body composition'], 'conditions': ['Metabolic Syndrome']}, 'descriptionModule': {'briefSummary': 'The investigators specific objective is to determine the effectiveness of a pulse-based diet combined with an exercise training program for reducing the risk of metabolic syndrome in older adults. The metabolic syndrome is a cluster of risk factors that predispose one to the development of diabetes and cardiovascular disease. These risk factors include increased abdominal obesity, high blood triglyceride levels, low blood high-density lipoproteins, high blood pressure, high blood glucose and insulin levels, and increased inflammation. The investigators hypothesize that a pulse-based diet combined with exercise training will be very effective for reducing the risks of the metabolic syndrome because each intervention acts on different components of the metabolic syndrome.\n\nThe design will involve a randomized single-blind cross-over for the pulse-based diet, and a single blind randomized parallel group assignment for the exercise-based intervention. 100 subjects will be randomized to receive the pulse-based diet or their regular diet for 2 months and then cross-over to receive the opposite diet for 2 months, separated by a one-month "wash out". Subjects will be further randomized to exercise or "exercise placebo" groups for the duration of the trial (i.e. 5 months). The exercise intervention will involve aerobic training as this is most effective for reducing metabolic syndrome risk.\n\nDependent variables will be measured at 4 time points: baseline, after the first 2-month diet, before the second 2-month diet (i.e. after the washout) and at the end of the second 2-month diet. These variables will include: Serum triglycerides, high density lipoproteins, C-reactive protein (as an inflammatory marker), glucose, and insulin, trunk body fat, and blood pressure. A composite metabolic syndrome score will be determined by converting each of these variables into Z-scores and determining the mean of these Z-scores. Secondary variables will include other serum lipids, including low density lipoproteins and total cholesterol.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* men and women over the age of 50y\n\nExclusion Criteria:\n\n* allergies to beans, peas, lentils, chickpeas\n* currently taking medication for blood lipids\n* currently engaged in vigorous aerobic activity greater than 2 times per week'}, 'identificationModule': {'nctId': 'NCT00800033', 'briefTitle': 'Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome', 'organization': {'class': 'OTHER', 'fullName': 'University of Saskatchewan'}, 'officialTitle': 'Effectiveness of Pulse-Based Foods Combined With Exercise for Improving Components of the Metabolic Syndrome', 'orgStudyIdInfo': {'id': 'PRO0822'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Aerobic exercise training', 'interventionNames': ['Behavioral: Aerobic exercise training']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Resistance exercise training', 'interventionNames': ['Behavioral: Aerobic exercise training']}, {'type': 'EXPERIMENTAL', 'label': 'pulse diet', 'description': 'Pulse based diet containing peas, lentils, and beans', 'interventionNames': ['Dietary Supplement: pulse based diet']}, {'type': 'NO_INTERVENTION', 'label': 'Regular diet'}], 'interventions': [{'name': 'Aerobic exercise training', 'type': 'BEHAVIORAL', 'description': 'Walking, jogging, rowing, cycling to be done 5 times per week for 45 minutes per session (3 supervised sessions, 2 sessions at home) for 5 months', 'armGroupLabels': ['Aerobic exercise training', 'Resistance exercise training']}, {'name': 'pulse based diet', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Two pulse-based meals per day (lentils, beans, chickpeas, or peas) for 2 months, followed by 1-month washout and then a normal diet for 2 months (order of diets is randomized)', 'armGroupLabels': ['pulse diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'S7N 5B2', 'city': 'Saskatoon', 'state': 'Saskatchewan', 'country': 'Canada', 'facility': 'College of Kinesiology, University of Saskatchewan', 'geoPoint': {'lat': 52.13238, 'lon': -106.66892}}], 'overallOfficials': [{'name': 'Philip D Chilibeck, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Saskatchewan'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Saskatchewan', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Phil Chilibeck', 'investigatorAffiliation': 'University of Saskatchewan'}}}}