Ignite Creation Date:
2025-12-24 @ 7:59 PM
Ignite Modification Date:
2025-12-25 @ 5:33 PM
Study NCT ID:
NCT06366204
Status:
COMPLETED
Last Update Posted:
2025-07-30
First Post:
2024-04-10
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Lysine Requirements During Lactation
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001942', 'term': 'Breast Feeding'}], 'ancestors': [{'id': 'D005247', 'term': 'Feeding Behavior'}, {'id': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'SINGLE_GROUP', 'interventionModelDescription': 'Single day interventions; Repeated measures design.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 19}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2024-01-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-07', 'completionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-07-28', 'studyFirstSubmitDate': '2024-04-10', 'studyFirstSubmitQcDate': '2024-04-10', 'lastUpdatePostDateStruct': {'date': '2025-07-30', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-04-15', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-17', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Carbon 13 Oxidation', 'timeFrame': '8 hours', 'description': 'Urine and breath samples will be collected to measure the rate of L-\\[1-13C\\]phenylalanine oxidation.'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Dietary Reference Intake', 'Lysine', 'Lactation', 'Indicator Amino Acid Oxidation', 'Lysine Requirements', 'Stable Isotopes'], 'conditions': ['Lactation', 'Breastfeeding, Exclusive', 'Breastfeeding']}, 'descriptionModule': {'briefSummary': "The study aims to establish lysine requirements using the indicator amino acid oxidation (IAAO) method in women exclusively breastfeeding a single infant aged 3-4 months, and how maternal lysine needs change once infant transition to complimentary feeding at a later age of 9-10 months. Each 8-hour study day will have an assigned test lysine intake ranging from deficient to excess. The diets will be provided in a complete protein shake format, meeting all nutrient requirements except for the test lysine intake. Breath samples evaluate the indicator's oxidation to determine protein synthesis in response to lysine intake. Urine and one blood sample will be collected to assess metabolite concentrations.", 'detailedDescription': 'This study is a single-day intervention study where participants will be studied in a repeated measures design, with an individual having the option of participating in up 4 test lysine intakes for each lactation stage. A minimum of 10 women will be recruited, and the investigators hope to retain the same women for 8 study days to minimize data variability.\n\nPotential participants will meet the researchers for a 1-hour preliminary assessment, where the investigators will evaluate their eligibility to participate in the study. During each study day, the participants will randomly receive a lysine test intake ranging from deficient to excess. The study day diets will consist of 8 hourly isocaloric and isonitrogenous meals in a protein shake, each presenting 1/12 of the daily energy requirement. The diets are composed of crystalline amino acid mixtures based on the composition of egg protein.\n\nA Carbon-13 (13C) stable isotope tracer ( L-\\[1-13C\\]phenylalanine) will be added to the 5th-8th meal. The investigators will measure the rate of oxidation of this tracer expired in breath and the flux of this tracer by its enrichment in urine. The investigators will also collect a single blood sample to measure lysine metabolites. Lysine requirements will be determined by a two-phase linear regression crossover model on L-\\[1-13C\\]phenylalanine tracer oxidation using mixed-models regression to take repeated measures into account. The oxidation rate of the indicator amino acid exhibits a linear increase as the lysine intake rises until it reaches a plateau. The point at which this steady state is reached signifies that the test amino acid is predominantly utilized for protein synthesis. The primary endpoint is the lysine intake level at which the transition occurs from indicator oxidation (linear increase) to protein synthesis (plateau).'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '40 Years', 'minimumAge': '20 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Healthy\n* Female\n* 20-40 years\n* Had a singleton pregnancy and is breastfeeding a single child.\n* Exclusively breastfeeding an infant 3 - 4 months of age OR complimentary. feeding an infant 9-10 months of age.\n\nExclusion Criteria:\n\n* Participants not in good health or have a history of metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders.\n* Participants that had major pregnancy or delivery complications (e.g., preeclampsia/ eclampsia, placenta previa, postpartum haemorrhage, neonatal intensive care, gestational diabetes).\n* Participants with substance dependence issues (e.g., nicotine, alcohol, marijuana, illicit drugs).\n* Participants that have had breast surgery that may impact lactation, lactogenesis or breastfeeding.\n* Participants that use medications that affect lactation (e.g. estrogenic birth control, anti-dopaminergic drugs, Methyldopa) or other continuous prescription medication.\n* Participants with a pre-pregnancy BMI below 18 kg/m² or above 28 kg/m².\n* Participants who are below 20 years of age or greater than 40 years of age.\n* Infants' weight and length are under 3rd or above the 97th percentile, using the World Health Organization (WHO) percentile growth chart.\n* Infants born before 38 weeks or after 42 weeks of gestation.\n* Infants who use infant formula milk.\n* Infants with known metabolic, cardiovascular, neurological, genetic, endocrine, immune, or physical mobility disorders."}, 'identificationModule': {'nctId': 'NCT06366204', 'briefTitle': 'Lysine Requirements During Lactation', 'organization': {'class': 'OTHER', 'fullName': 'University of British Columbia'}, 'officialTitle': 'Determining Dietary Lysine Requirements in Healthy Lactating Women Using the Indicator Amino Acid Oxidation Technique', 'orgStudyIdInfo': {'id': 'H23-03119'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Test Lysine Intake', 'description': 'Randomly assigned one of 7 test lysine intakes that range from deficient to excess (12mg/kg/d to 84mg/kg/d). Participants may complete up to 4 study days, at different randomly assigned intakes.', 'interventionNames': ['Other: Dietary Lysine Intakes']}], 'interventions': [{'name': 'Dietary Lysine Intakes', 'type': 'OTHER', 'description': "Participants consume 8 hourly meals that contain the assigned test lysine intake. Each meal will provide one-twelfth of the participants' daily energy requirements as estimated by 1.7 x Resting Energy Expenditure (REE) and adequate protein at 1.5 g.kg.d, to maintain a metabolic steady state. The meals are in the form of a crystalline amino acid protein shake, and nitrogenous free cookies.", 'armGroupLabels': ['Test Lysine Intake']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'V5Z 4H4', 'city': 'Vancouver', 'state': 'British Columbia', 'country': 'Canada', 'facility': "BC Children's Hospital Research Institute", 'geoPoint': {'lat': 49.24966, 'lon': -123.11934}}], 'overallOfficials': [{'name': 'Rajavel Elango', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of British Columbia'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of British Columbia', 'class': 'OTHER'}, 'collaborators': [{'name': 'Canadian Institutes of Health Research (CIHR)', 'class': 'OTHER_GOV'}], 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Rajavel Elango, PhD', 'investigatorAffiliation': 'University of British Columbia'}}}}