Ignite Creation Date:
2025-12-25 @ 2:04 AM
Ignite Modification Date:
2025-12-26 @ 1:39 AM
Study NCT ID:
NCT01692860
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2012-09-21
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-01'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2012-09-21', 'studyFirstSubmitQcDate': '2012-09-21', 'lastUpdatePostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-09-25', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-09', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'weight loss', 'timeFrame': '20 weeks'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['the impact of a higher dairy-based protein diet in', 'combination with energy restriction on muscle health,', 'metabolic health (including blood pressure) in overweight', 'and obese, middle aged adults'], 'conditions': ['Sarcopenia', 'Metabolic Disease', 'High Blood Pressure']}, 'referencesModule': {'references': [{'pmid': '26864362', 'type': 'DERIVED', 'citation': 'Zhou J, Kim JE, Armstrong CL, Chen N, Campbell WW. Higher-protein diets improve indexes of sleep in energy-restricted overweight and obese adults: results from 2 randomized controlled trials. Am J Clin Nutr. 2016 Mar;103(3):766-74. doi: 10.3945/ajcn.115.124669. Epub 2016 Feb 10.'}]}, 'descriptionModule': {'briefSummary': '. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome', 'detailedDescription': 'Currently, over 47 million adults in the United States are known to have metabolic syndrome. Metabolic syndrome is comprised of a cluster of conditions including obesity, elevated cholesterol, high blood sugar, and high blood pressure. People with metabolic syndrome have an increased risk for the development of chronic diseases such as cardiovascular disease and diabetes. Recent studies have shown that a build-up of fat in the muscle of overweight and obese people may partially explain the link between metabolic syndrome and the development of chronic diseases. There is evidence to suggest that diets with a higher amount of protein can improve some aspects of metabolic syndrome, including the build-up of fat in muscle. The purpose of this study is to examine the effects of eating a larger amount of dairy-based protein on risk factors for metabolic syndrome.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '35 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\nBMI: 25-38 ,male or female; age 35-65 y; weight stable (± 3 kg) during last 3 months; no acute illness; not diabetic, pregnant or lactating; not currently (or within last 3 months) following an exercise or weight loss program; non-smoking; not taking BP medication; not lactose intolerant,\n\nExclusion Criteria:\n\nSubjects will be excluded if baseline protein intake is less than 0.6 or greater than 1.6 g•kg-1•d-1 Subjects will also be excluded if they have any chronic or acute condition which will increase risk of illness or injury during study participation as determined by our study physician such as high BP, high fasting glucose, metabolic syndrome, etc.'}, 'identificationModule': {'nctId': 'NCT01692860', 'acronym': 'S28', 'briefTitle': 'Effects of Milk Protein Concentrate on Overall Health During Weight Loss in Overweight/Obese Adults', 'organization': {'class': 'OTHER', 'fullName': 'Purdue University'}, 'officialTitle': 'Effects of Milk Protein Concentrate on Blood Pressure, Inflammation, Muscle Health During Weight Loss in Overweight/Obese Adults', 'orgStudyIdInfo': {'id': '1109011319'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'High protein consumption', 'description': 'Intervention, energy restriction. This arm has a dietary protein intake of 1.5g/kg/d', 'interventionNames': ['Other: Energy Restriction']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Normal protein consumption', 'description': 'Intervention, energy restriction. This arm has a dietary protein intake of .8g/kg/d', 'interventionNames': ['Other: Energy Restriction']}], 'interventions': [{'name': 'Energy Restriction', 'type': 'OTHER', 'description': 'Subjects consume 750 kcal/d of energy below their need', 'armGroupLabels': ['High protein consumption', 'Normal protein consumption']}]}, 'contactsLocationsModule': {'locations': [{'zip': '47907', 'city': 'West Lafayette', 'state': 'Indiana', 'country': 'United States', 'facility': 'Purdue University - Stone Hall 700 W State St', 'geoPoint': {'lat': 40.42587, 'lon': -86.90807}}], 'overallOfficials': [{'name': 'Wayne W Campbell, Ph. D.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Purdue University'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Purdue University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Wayne Campbell, Ph.D.', 'investigatorFullName': 'Wayne Campbell', 'investigatorAffiliation': 'Purdue University'}}}}