Ignite Creation Date:
2025-12-24 @ 9:11 PM
Ignite Modification Date:
2025-12-25 @ 7:00 PM
Study NCT ID:
NCT00700804
Status:
COMPLETED
Last Update Posted:
2018-07-02
First Post:
2008-06-18
Is NOT Gene Therapy:
False
Has Adverse Events:
True
Brief Title:
Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D000073600', 'term': 'Diet, High-Protein'}, {'id': 'D018753', 'term': 'Diet, Protein-Restricted'}], 'ancestors': [{'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'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'janetrhunt@gmail.com', 'phone': '701-795-8353', 'title': 'Janet Hunt, PhD', 'organization': 'United States Department of Agriculture (USDA) Grand Forks Human Nutrition Reserch Center'}, 'certainAgreement': {'piSponsorEmployee': True}}, 'adverseEventsModule': {'eventGroups': [{'id': 'EG000', 'title': 'High Calcium Diet', 'description': 'Women consumed diets containing 1500 milligrams of calcium daily', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}, {'id': 'EG001', 'title': 'Low Calcium Diet', 'description': 'Women consumed diets containing 600 milligrams of calcium daily', 'otherNumAtRisk': 17, 'otherNumAffected': 0, 'seriousNumAtRisk': 17, 'seriousNumAffected': 0}], 'frequencyThreshold': '4'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'SECONDARY', 'title': 'Serum Insulin-like Growth Factor 1 (IGF-1)', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Calcium Diet', 'description': 'Women consumed diets containing 1500 milligrams of calcium daily'}, {'id': 'OG001', 'title': 'Low Calcium Diet', 'description': 'Women consumed diets containing 600 milligrams of calcium daily'}], 'classes': [{'title': 'High Protein Diet', 'categories': [{'measurements': [{'value': '5.23', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '5.07', 'spread': '0.12', 'groupId': 'OG001'}]}]}, {'title': 'Low Protein Diet', 'categories': [{'measurements': [{'value': '4.96', 'spread': '0.12', 'groupId': 'OG000'}, {'value': '4.87', 'spread': '0.12', 'groupId': 'OG001'}]}]}], 'paramType': 'GEOMETRIC_MEAN', 'timeFrame': '7 weeks', 'unitOfMeasure': 'nanomoles per liter (nmols/L)', 'dispersionType': 'Standard Error', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Calcium Absorption', 'denoms': [{'units': 'Participants', 'counts': [{'value': '14', 'groupId': 'OG000'}, {'value': '13', 'groupId': 'OG001'}]}], 'groups': [{'id': 'OG000', 'title': 'High Calcium Diet', 'description': 'Women consumed diets containing 1500 milligrams of calcium daily'}, {'id': 'OG001', 'title': 'Low Calcium Diet', 'description': 'Women consumed diets containing 600 milligrams of calcium daily'}], 'classes': [{'title': 'High Protein Diet', 'categories': [{'measurements': [{'value': '18.1', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '29.5', 'spread': '2.5', 'groupId': 'OG001'}]}]}, {'title': 'Low Protein Diet', 'categories': [{'measurements': [{'value': '18.0', 'spread': '2.5', 'groupId': 'OG000'}, {'value': '26', 'spread': '2.5', 'groupId': 'OG001'}]}]}], 'analyses': [{'pValue': '0.05', 'groupIds': ['OG000', 'OG001'], 'paramType': 'Mean Difference (Final Values)', 'paramValue': '9.7', 'dispersionType': 'STANDARD_DEVIATION', 'dispersionValue': '2.5', 'estimateComment': 'Reported analysis is the main effect of Calcium (High vs Low) from the Mixed Model Analysis which averages across the two levels of dietary protein. The main effect of protein and the calcium x protein interaction were not statistically significant.', 'statisticalMethod': 'Mixed Models Analysis', 'nonInferiorityType': 'SUPERIORITY_OR_OTHER', 'statisticalComment': 'Effects of calcium (Ca), protein \\& their interaction were tested using repeated measures analysis of variance (subjects nested under High or Low Ca)'}], 'paramType': 'MEAN', 'timeFrame': '17 weeks', 'description': 'Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time', 'unitOfMeasure': 'percentage of Calcium absorbed', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED', 'populationDescription': 'Only participants which completed both protein diet periods were included in the statistical analysis'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'High Calcium Diet', 'description': 'Women consumed diets containing 1500 milligrams of calcium daily'}, {'id': 'FG001', 'title': 'Low Calcium Diet', 'description': 'Women consumed diets containing 600 milligrams of calcium daily'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '17'}, {'groupId': 'FG001', 'numSubjects': '17'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '14'}, {'groupId': 'FG001', 'numSubjects': '13'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '3'}, {'groupId': 'FG001', 'numSubjects': '4'}]}], 'dropWithdraws': [{'type': 'Withdrawal by Subject', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '2'}]}, {'type': 'Protocol Violation', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}, {'type': 'Loose Stools', 'reasons': [{'groupId': 'FG000', 'numSubjects': '1'}, {'groupId': 'FG001', 'numSubjects': '1'}]}]}], 'recruitmentDetails': 'Post menopausal women willing to eat controlled diet at United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center for 14 weeks', 'preAssignmentDetails': 'Subjects were assigned to either the High or Low Calcium diets. The subjects then consumed the high and low protein diets in random order, i.e. half of the subjects consumed high protein, then low protein while the other half consumed low protein, then the high protein diet. Drop-outs were replaced.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}], 'groups': [{'id': 'BG000', 'title': 'High Calcium Diet', 'description': 'Women consumed diets containing 1500 milligrams of calcium daily'}, {'id': 'BG001', 'title': 'Low Calcium Diet', 'description': 'Women consumed diets containing 600 milligrams of calcium daily'}, {'id': 'BG002', 'title': 'Total', 'description': 'Total of all reporting groups'}], 'measures': [{'title': 'Age, Categorical', 'classes': [{'categories': [{'title': '<=18 years', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}, {'title': 'Between 18 and 65 years', 'measurements': [{'value': '16', 'groupId': 'BG000'}, {'value': '14', 'groupId': 'BG001'}, {'value': '30', 'groupId': 'BG002'}]}, {'title': '>=65 years', 'measurements': [{'value': '1', 'groupId': 'BG000'}, {'value': '3', 'groupId': 'BG001'}, {'value': '4', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Age, Continuous', 'classes': [{'categories': [{'measurements': [{'value': '57', 'spread': '5', 'groupId': 'BG000'}, {'value': '58', 'spread': '6', 'groupId': 'BG001'}, {'value': '57', 'spread': '5', 'groupId': 'BG002'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'categories': [{'title': 'Female', 'measurements': [{'value': '17', 'groupId': 'BG000'}, {'value': '17', 'groupId': 'BG001'}, {'value': '34', 'groupId': 'BG002'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}, {'value': '0', 'groupId': 'BG001'}, {'value': '0', 'groupId': 'BG002'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'FACTORIAL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 34}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2003-06'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2005-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-24', 'studyFirstSubmitDate': '2008-06-18', 'resultsFirstSubmitDate': '2008-12-30', 'studyFirstSubmitQcDate': '2008-06-18', 'lastUpdatePostDateStruct': {'date': '2018-07-02', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2009-04-09', 'studyFirstPostDateStruct': {'date': '2008-06-19', 'type': 'ESTIMATED'}, 'resultsFirstPostDateStruct': {'date': '2009-06-02', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2004-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Calcium Absorption', 'timeFrame': '17 weeks', 'description': 'Retention of Calcium-47 was monitored for 28 days by whole body scintillation counting. The percentage of Calcium-47 absorbed was estimated from the y-intercept of the linear portion of a semilogarithmic retention plot of percent Calcium-47 retained vs time'}], 'secondaryOutcomes': [{'measure': 'Serum Insulin-like Growth Factor 1 (IGF-1)', 'timeFrame': '7 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Calcium retention', 'dietary protein', 'dietary calcium'], 'conditions': ['Dietary Proteins']}, 'descriptionModule': {'briefSummary': 'The primary objective is to determine whether meat interacts positively with calcium to improve calcium retention. The secondary objective is to determine whether any interaction between dietary protein and calcium affects biomarkers of bone metabolism.', 'detailedDescription': 'This study tests the effects of dietary protein and calcium on calcium retention and indices of bone metabolism. It is a controlled feeding trial with a randomized crossover design (2x2 Factorial), studying 34 healthy post-menopausal women. The women are blocked on Body Mass Index (weight in kilograms divided by height in meters squared)and randomly assigned to a high calcium (HC,1500 milligrams per day) or low calcium (LC, 600 milligrams per day) group, and consume both low protein (LP,10% protein) and high protein (HP, 20% protein) diets for 7 weeks each. There is a 3-week "washout" between dietary periods, during which the subjects consume self-selected diets. After 3 week equilibration to each diet, the 2-day rotating menu is extrinsically labeled with a Calcium-47 radiotracer and retention is monitored for 28 days by whole body scintillation counting. In addition to Calcium retention, other endpoints include urinary indices of acid excretion and urine serum indices of bone resorption.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '50 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* at least 3 years since last menses\n* bone mineral density equal to or greater than 2.5 standard deviations from average bone mineral density for young adults,\n* body mass index equal to or less than 35 kilograms/meter squared\n\nExclusion Criteria:\n\n* taking prescription medication other than hormone replacement therapy'}, 'identificationModule': {'nctId': 'NCT00700804', 'briefTitle': 'Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?', 'organization': {'class': 'FED', 'fullName': 'USDA Grand Forks Human Nutrition Research Center'}, 'officialTitle': 'Meat Protein and Calcium: Do They Interact Synergistically or Antagonistically?', 'orgStudyIdInfo': {'id': 'GFHNRC064'}, 'secondaryIdInfos': [{'id': 'IRB-200307-010'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High Calcium Diet', 'interventionNames': ['Behavioral: High Protein Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Low Calcium Diet', 'interventionNames': ['Behavioral: Low Protein Diet']}], 'interventions': [{'name': 'High Protein Diet', 'type': 'BEHAVIORAL', 'description': 'High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm', 'armGroupLabels': ['High Calcium Diet']}, {'name': 'Low Protein Diet', 'type': 'BEHAVIORAL', 'description': 'High and low protein diets with meat as a primary protein source, tested in a cross-over design for each arm', 'armGroupLabels': ['Low Calcium Diet']}]}, 'contactsLocationsModule': {'locations': [{'zip': '58202', 'city': 'Grand Forks', 'state': 'North Dakota', 'country': 'United States', 'facility': 'United States Department of Agriculture (USDA) Grand Forks Human Nutrition Research Center', 'geoPoint': {'lat': 47.92526, 'lon': -97.03285}}], 'overallOfficials': [{'name': 'Janet R Hunt, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'USDA Grand Forks Human Nutrition Research Center'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'USDA Grand Forks Human Nutrition Research Center', 'class': 'FED'}, 'collaborators': [{'name': "National Cattlemen's Beef Association, a contractor to the Beef Checkoff", 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}