Ignite Creation Date:
2025-12-24 @ 11:47 AM
Ignite Modification Date:
2026-02-05 @ 11:45 PM
Study NCT ID:
NCT01847261
Status:
COMPLETED
Last Update Posted:
2019-10-07
First Post:
2013-04-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}], '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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2014-12', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-10-03', 'studyFirstSubmitDate': '2013-04-24', 'studyFirstSubmitQcDate': '2013-05-01', 'lastUpdatePostDateStruct': {'date': '2019-10-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fractional Synthetic Rate (Muscle Protein Synthesis)', 'timeFrame': 'baseline, 3 hrs, 5 hrs', 'description': 'The fractional synthesis rate (FSR) of mixed muscle proteins will be calculated from the incorporation rate of L-\\[ring-13C6\\]Phenylalanine into the mixed muscle proteins, and the free-tissue phenylalanine enrichment.'}], 'secondaryOutcomes': [{'measure': 'Anti-inflammatory and Anti-oxidant Markers', 'timeFrame': 'baseline, 3 hrs, 5 hrs', 'description': 'Proteins will be assessed that are markers of oxidative damage and inflammation (NFkB, IL-1, IL-6) and proteolysis (MuRF, MAFBx).'}, {'measure': 'Intracellular Signalling Genes and Proteins', 'timeFrame': 'baseline, 3 hrs, 5 hrs', 'description': 'Phosphorylation of Mammalian Target of Rapamycin (mTOR) pathway will be measured using Western blot techniques'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['soy', 'whey', 'muscle', 'older', 'mTOR', 'sarcopenia'], 'conditions': ['Muscle Synthesis']}, 'referencesModule': {'references': [{'pmid': '27798330', 'type': 'DERIVED', 'citation': 'Borack MS, Reidy PT, Husaini SH, Markofski MM, Deer RR, Richison AB, Lambert BS, Cope MB, Mukherjea R, Jennings K, Volpi E, Rasmussen BB. Soy-Dairy Protein Blend or Whey Protein Isolate Ingestion Induces Similar Postexercise Muscle Mechanistic Target of Rapamycin Complex 1 Signaling and Protein Synthesis Responses in Older Men. J Nutr. 2016 Dec;146(12):2468-2475. doi: 10.3945/jn.116.231159. Epub 2016 Oct 26.'}]}, 'descriptionModule': {'briefSummary': 'During aging there is a tendency for muscle protein synthesis (growth) to become less efficient and the resulting consequence leads to reduced muscle mass (sarcopenia) which can affect strength and mobility. Protein consumption may be one opportunity to alleviate this problem especially when consumed in appropriate amounts following resistance training. This study is designed to determine if a soy dairy protein blend, shown to be effective in younger adults, will produce beneficial muscle protein synthesis in older healthy adults following resistance exercise.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '55 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n55-70 yr olds Stable Body weight\n\nExclusion Criteria:\n\n1. Exercise training (\\>2 weekly sessions of moderate to high intensity aerobic or resistance exercise)\n2. Significant heart, liver, kidney, blood, respiratory disease or thyroid issues\n3. Peripheral vascular disease\n4. Orthopedic injury that prohibits participation in the exercise training\n5. Diabetes mellitus or other untreated endocrine disease\n6. Active cancer (all groups) and history of cancer\n7. Acute infectious disease or history of chronic infections (e.g. TB, hepatitis, HIV, herpes)\n8. Neurologic Injury or disease\n9. Recent (within 6 months) treatment with anabolic steroids, or corticosteroids.\n10. Alcohol or drug abuse\n11. Tobacco use (smoking or chewing)\n12. Malnutrition (BMI \\< 20 kg/m2, hypoalbuminemia, and/or hypotransferrinemia)\n13. Obesity (BMI \\> 30 kg/m2)\n14. Low hemoglobin levels (below normal values)\n15. Food allergies\n16. Taking dietary supplements such as green tea, omega 3 fatty acids, etc.\n17. Females'}, 'identificationModule': {'nctId': 'NCT01847261', 'briefTitle': 'Effects of Protein Blends on Muscle Protein Synthesis in Healthy Older Adults', 'organization': {'class': 'INDUSTRY', 'fullName': 'DuPont Nutrition and Health'}, 'officialTitle': 'A Randomized, Controlled Double Blind Acute Study: Effects of Protein Blends on Muscle Protein Synthesis and Breakdown in Healthy Older Adults', 'orgStudyIdInfo': {'id': 'IRB #12-226'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Soy Dairy Protein Blend', 'description': '30 grams of Soy Dairy Protein Blend given as a single beverage following leg resistance exercise', 'interventionNames': ['Dietary Supplement: Soy Dairy Protein Blend']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Positive Control (Dairy Whey Protein)', 'description': '30 grams of Dairy Whey Protein will be given as a single beverage following leg resistance exercise', 'interventionNames': ['Dietary Supplement: Positive Control (Dairy Whey Protein)']}], 'interventions': [{'name': 'Soy Dairy Protein Blend', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Soy Dairy Protein Blend']}, {'name': 'Positive Control (Dairy Whey Protein)', 'type': 'DIETARY_SUPPLEMENT', 'armGroupLabels': ['Positive Control (Dairy Whey Protein)']}]}, 'contactsLocationsModule': {'locations': [{'zip': '77555', 'city': 'Galveston', 'state': 'Texas', 'country': 'United States', 'facility': 'University of Texas Medical Branch', 'geoPoint': {'lat': 29.30135, 'lon': -94.7977}}], 'overallOfficials': [{'name': 'Blake Rasmussen, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Texas'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'DuPont Nutrition and Health', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}