Ignite Creation Date:
2025-12-26 @ 10:34 AM
Ignite Modification Date:
2025-12-31 @ 2:34 PM
Study NCT ID:
NCT01109628
Status:
COMPLETED
Last Update Posted:
2025-04-04
First Post:
2010-02-12
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People
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': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 65}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-04-01', 'studyFirstSubmitDate': '2010-02-12', 'studyFirstSubmitQcDate': '2010-04-21', 'lastUpdatePostDateStruct': {'date': '2025-04-04', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2010-04-23', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2011-07', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in skeletal muscle mass', 'timeFrame': 'Baseline, 3 months and 6 months'}], 'secondaryOutcomes': [{'measure': 'Physical performance', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': 'Blood parameters related to the outcome measures', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': 'Dietary intake', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': 'Physical activity', 'timeFrame': 'Baseline, 3 months and 6 months'}, {'measure': 'Cognitive performance', 'timeFrame': 'Baseline and 6 months'}, {'measure': 'Blood pressure', 'timeFrame': 'Baseline, 3 months and 6 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['sarcopenia', 'frail elderly', 'protein drink', 'skeletal muscle mass', 'muscle mass in elderly'], 'conditions': ['Sarcopenia']}, 'referencesModule': {'references': [{'pmid': '24374288', 'type': 'DERIVED', 'citation': 'van de Rest O, van der Zwaluw NL, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. Effect of resistance-type exercise training with or without protein supplementation on cognitive functioning in frail and pre-frail elderly: secondary analysis of a randomized, double-blind, placebo-controlled trial. Mech Ageing Dev. 2014 Mar-Apr;136-137:85-93. doi: 10.1016/j.mad.2013.12.005. Epub 2013 Dec 27.'}, {'pmid': '24045855', 'type': 'DERIVED', 'citation': 'van der Zwaluw NL, van de Rest O, Tieland M, Adam JJ, Hiddink GJ, van Loon LJ, de Groot LC. The impact of protein supplementation on cognitive performance in frail elderly. Eur J Nutr. 2014 Apr;53(3):803-12. doi: 10.1007/s00394-013-0584-9. Epub 2013 Sep 18.'}, {'pmid': '22889730', 'type': 'DERIVED', 'citation': 'Tieland M, van de Rest O, Dirks ML, van der Zwaluw N, Mensink M, van Loon LJ, de Groot LC. Protein supplementation improves physical performance in frail elderly people: a randomized, double-blind, placebo-controlled trial. J Am Med Dir Assoc. 2012 Oct;13(8):720-6. doi: 10.1016/j.jamda.2012.07.005. Epub 2012 Aug 11.'}]}, 'descriptionModule': {'briefSummary': 'The present study is designed to investigate whether timed protein supplementation will increase skeletal muscle mass in the frail elderly population.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Frail elderly individuals\n* Able to understand and perform the study procedures\n\nExclusion Criteria:\n\n* Type I or type II diabetes (fasted blood glucose level ≥7,0 mmol)\n* No recent history (within 2 years) of participating in any regular resistance exercise training program (general questionnaire)\n* Use of anti-coagulation medication (except of Acetyl Salicyl acid)\n* Renal insufficiency (eGFR \\<60 mL/min/1.73 m2)\n* Allergic or sensitive for milk proteins'}, 'identificationModule': {'nctId': 'NCT01109628', 'acronym': 'ProMuscle', 'briefTitle': 'Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'Protein Supplementation to Promote Muscle Protein Anabolism in Frail Elderly People', 'orgStudyIdInfo': {'id': 'A1002-1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Protein drink', 'interventionNames': ['Dietary Supplement: Protein drink']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo drink', 'interventionNames': ['Dietary Supplement: Placebo drink']}], 'interventions': [{'name': 'Protein drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Twice a day during 6 months', 'armGroupLabels': ['Protein drink']}, {'name': 'Placebo drink', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Twice a day during 6 months', 'armGroupLabels': ['Placebo drink']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6703HD', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'collaborators': [{'name': 'Maastricht University Medical Center', 'class': 'OTHER'}, {'name': 'Top Institute Food and Nutrition', 'class': 'OTHER'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Lisette de Groot', 'investigatorAffiliation': 'Wageningen University'}}}}