Ignite Creation Date:
2025-12-24 @ 2:41 PM
Ignite Modification Date:
2026-01-04 @ 4:56 PM
Study NCT ID:
NCT02971059
Status:
COMPLETED
Last Update Posted:
2018-09-18
First Post:
2016-11-14
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Phenylalanine Requirement of Adults >65 Years.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-09', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-09-14', 'studyFirstSubmitDate': '2016-11-14', 'studyFirstSubmitQcDate': '2016-11-18', 'lastUpdatePostDateStruct': {'date': '2018-09-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-11-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenylalanine Requirement', 'timeFrame': 'Baseline', 'description': 'To determine phenylalanine requirement by measuring the oxidation of 13CO2 in breath in response to graded phenylalanine intakes'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Elderly', 'Phenylalanine', 'Healthy'], 'conditions': ['Older Adults']}, 'referencesModule': {'references': [{'pmid': '31271193', 'type': 'DERIVED', 'citation': 'Martin KE, Pencharz PB, Rafii M, Ball RO, Szwiega S, Elango R, Courtney-Martin G. The Phenylalanine Requirement of Elderly Men and Women Measured by Direct 13C Carbon Oxidation Method Is Similar to That of Young Adults. J Nutr. 2019 Oct 1;149(10):1776-1784. doi: 10.1093/jn/nxz137.'}]}, 'descriptionModule': {'briefSummary': 'Currently there are insufficient published studies on amino acid requirements in the elderly. Phenylalanine is one of the indispensable amino acids. Low levels of phenylalanine has been observed in in the blood of older adults. It is due the increased uptake by the liver and intestine. This decreased levels of phenylalanine could lead to decreased skeletal muscle protein synthesis. Requirement for elderly individuals have been set based on studies conducted in younger adults hence may be inaccurate. The goal of this study is to directly measure the phenylalanine requirement of male and female elderly subjects over 65 years using the direct amino acid oxidation (DAAO) technique.', 'detailedDescription': '1. To determine and compare the phenylalanine requirement of healthy elderly male and female adults over the age of 65 years using the DAAO technique (by measuring the oxidation of L-\\[1-13 C\\] phenylalanine to 13 CO 2 \\[F 13 CO 2\\] ) in response to graded intakes of phenylalanine.\n2. To compare the requirement so derived to that of young healthy adult previously determined in our lab.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n1. Healthy elderly males and females \\> 65 years\n2. Willingness to participate in the study and completed the screening procedures (height, weight, fasting blood sample and medical history questionnaire).\n3. No recent history of weight loss\n4. Absence of chronic disease or acute illness that could affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications.\n5. Non-smoking\n6. Willingness to consume the diet provided\n\nExclusion Criteria:\n\n1. Presence of disease known to affect protein and AA metabolism (diabetes, cancer, liver or kidney disease, HIV, acute cold or flu, hypo or hyperthyroidism, rheumatoid arthritis treated with anti-inflammatory medications).\n2. On medications known to affect protein and amino acid metabolism (steroids).\n3. Recent significant weight loss.\n4. Individual on weight reducing diets.\n5. Inability to tolerate the diet\n6. Unwilling to have blood drawn from a venous access, or using a ventilated hood indirect calorimeter for the purposes of the study.\n7. Significant coffee consumption of more than 2 cups/day\n8. Significant alcohol consumption of more than one drink/day'}, 'identificationModule': {'nctId': 'NCT02971059', 'briefTitle': 'Phenylalanine Requirement of Adults >65 Years.', 'organization': {'class': 'OTHER', 'fullName': 'The Hospital for Sick Children'}, 'officialTitle': 'Phenylalanine Requirement of Healthy Older Adult Males and Females > 65 Years Determined by Direct Amino Acid Oxidation (DAAO) Method.', 'orgStudyIdInfo': {'id': '1000051682'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Adult Males >65 years', 'description': 'Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.', 'interventionNames': ['Dietary Supplement: Phenylalanine intake']}, {'type': 'EXPERIMENTAL', 'label': 'Adult Females >65 years', 'description': 'Participants will be seen initially for pre-study assessment (3 hour). They will then be studied weekly for up to 7 levels of phenylalanine intake (7 Study periods). Each study period will include a period of 3 days. The first 2 days they will consume a liquid milkshake based diet at home. On the 3rd day they will come to the hospital for a total of 8 hours.', 'interventionNames': ['Dietary Supplement: Phenylalanine intake']}], 'interventions': [{'name': 'Phenylalanine intake', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Phenylalanine will be provided as graded intakes ranging from 7-40 mg/kg/day', 'armGroupLabels': ['Adult Females >65 years', 'Adult Males >65 years']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5G1x8', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'The Hospital for Sick Children', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Glenda Courtney-Martin', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Hospital for Sick Children, Toronto, Ontario'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'The Hospital for Sick Children', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Project Investigator', 'investigatorFullName': 'Glenda Courtney-Martin', 'investigatorAffiliation': 'The Hospital for Sick Children'}}}}