Ignite Creation Date:
2025-12-24 @ 10:55 PM
Ignite Modification Date:
2026-01-03 @ 9:16 PM
Study NCT ID:
NCT03845569
Status:
COMPLETED
Last Update Posted:
2019-02-19
First Post:
2019-02-13
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Habitual Protein Intake on AA Tracer Oxidation
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': 'CROSSOVER', 'interventionModelDescription': 'Randomized crossover trial.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 5}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-02', 'completionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-02-14', 'studyFirstSubmitDate': '2019-02-13', 'studyFirstSubmitQcDate': '2019-02-14', 'lastUpdatePostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-02-19', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-04-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Phenylalanine excretion (F13CO2)', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Expressed as µmol/kg/h; phenylalanine excretion is determined via breath enrichment (F13CO2) of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry'}, {'measure': 'Phenylalanine oxidation (PheOX)', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'Expressed as µmol/kg/h; phenylalanine excretion is determined via breath and urine enrichment of the oral tracer. Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry and urinary L-\\[1-13C\\] phenylalanine was measured by liquid chromatography tandem mass spectrometry'}], 'secondaryOutcomes': [{'measure': 'Phenylalanine Rate of Appearance (PheRa/Flux)', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'In µmol/kg/h; phenylalanine rate of appearance is determined via urinary enrichment of the oral tracer by liquid chromatography tandem mass spectrometry.'}, {'measure': 'Net Protein Balance', 'timeFrame': 'Through study completion, an average of 3 months', 'description': 'In µmol/kg/h; calculated as the difference between whole-body protein synthesis and protein breakdown. ). Breath 13CO2 enrichment was measured by continuous-flow isotope ratio mass spectrometry and urinary L-\\[1-13C\\] phenylalanine was measured by liquid chromatography tandem mass spectrometry.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Amino acids', 'Protein', 'metabolism', 'IAAO', 'Tracer', 'Indicator amino acid', 'Resistance trained'], 'conditions': ['Protein/Amino Acid Metabolism', 'Indicator Amino Acid Oxidation Method']}, 'referencesModule': {'references': [{'pmid': '32391374', 'type': 'DERIVED', 'citation': 'Tinline-Goodfellow CT, West DWD, Malowany JM, Gillen JB, Moore DR. An Acute Reduction in Habitual Protein Intake Attenuates Post Exercise Anabolism and May Bias Oxidation-Derived Protein Requirements in Resistance Trained Men. Front Nutr. 2020 Apr 22;7:55. doi: 10.3389/fnut.2020.00055. eCollection 2020.'}]}, 'descriptionModule': {'briefSummary': "Protein is an essential nutrient that one's diet to maintain important bodily functions and to recover from exercise. Currently, the Indicator Amino Acid Oxidation method (IAAO) has been used to determine protein requirements in a variety of populations including children, neonates, the elderly and recently, resistance trained populations. This study serves to test the robustness of the IAAO method and to determine if high habitual dietary protein intake, as seen in resistance trained males, has the potential to influence the protein requirements determined by the IAAO method. Further, the current study also aims to determine how the body metabolizes or uses dietary protein and how it might change when consuming a protein intake that is less than what is habitually consumed.", 'detailedDescription': "This study employed a two-phase randomized crossover design, where participants performed both a High/Habitual protein phase and a moderate protein phase. The Habitual protein phase is designed to model resistance trained individual's habitual protein consumption by providing 2.2g/kg/d in a controlled diet. The Moderate protein phase is designed to investigate the impact of decreasing dietary protein intake to a moderate amount (1.2g/kg/d) over five days on protein metabolism. Both phases used the stable isotope L-\\[1-13C\\]Phenylalanine and metabolic trails were modelled after the indicator amino acid oxidation (IAAO) technique.\n\nHigh Protein Phase The high protein phase is three days in length, with diet-controlled throughout, and a metabolic trail on day 3. Participants will perform whole-body resistance exercise on days one and three.\n\nModerate protein phase The Moderate protein phase is seven days in length, with MT on days three, five and seven. Dietary intake will be controlled throughout the whole phase providing either 2.2 g/kg/d of protein (days one and two), or 1.2 g/kg/d (days three through seven). Full body resistance exercise will be performed performed on days one, three, five and seven.\n\nThis phase will allow measurement of protein metabolism over five days following a decrease in dietary protein intake, and to determine the effect of dietary changes on the IAAO method."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy, weight-trained individuals that have trained consistently for \\> 1 year\n* Habitually dietary protein consumption of 1.9 to 3.0g/kg/d\n* Train each muscle group (i.e. chest, back, legs) at least twice a week\n* Body mass stable in the last month\n* Meets strength relative-to-weight guidelines (adapted from Morton et al., 2016; Chilibeck et -al., 1997)\n\n * Bench Press: - Bodyweight (kg) \\* 1.25\n * Leg Press: - Bodyweight (kg) \\*4.0\n\nExclusion Criteria:\n\n* Inability to meet health and PA guidelines according to the PAR-Q+\n* Inability to adhere to any of the protocol guidelines (e.g. alcohol and caffeine consumption)\n* Regular tobacco use, screened by questionnaire\n* Illicit drug use (e.g. growth hormone, testosterone, etc.), screened by a survey in training log\n\n * 1 month sedentary in the last 6 months prior to study participation\n * 30 minutes of continuous cardio per exercise session\n* BMI \\> or equal to 35\n* Individual plans to increase or decrease body mass in the next 3 months\n* Use of supplements (excluding whey protein), such as creatine and beta-alanine, in the last 30 days'}, 'identificationModule': {'nctId': 'NCT03845569', 'acronym': 'HPI', 'briefTitle': 'Influence of Habitual Protein Intake on AA Tracer Oxidation', 'organization': {'class': 'OTHER', 'fullName': 'University of Toronto'}, 'officialTitle': 'Impact of Habitual Protein Intake on Estimates of Dietary Protein Requirements in Resistance Trained Athletes', 'orgStudyIdInfo': {'id': 'HPI'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Habitual Protein phase', 'description': "A trial investigating protein oxidation/metabolism that was used to model resistance trained individual's habitual dietary protein intake (2.2g/kg/d).", 'interventionNames': ['Other: Three day Controlled Diet']}, {'type': 'EXPERIMENTAL', 'label': 'Moderate Protein Phase', 'description': 'A series of three trials over a one week period investigating protein oxidation/metabolism that was used to investigate the metabolic response of decreased protein intake (1.2g/kg/d) over a period of five days (trials on days 1, 3, 5 following reduction in protein intake from 2.2g/kg/d to 1.2g/kg/d) relative to the Habitual protein phase trial.', 'interventionNames': ['Other: Dietary protein intake reduction']}], 'interventions': [{'name': 'Dietary protein intake reduction', 'type': 'OTHER', 'description': 'Following two days of controlled diet at 2.2g/kg/d of dietary protein, intake was reduced to 1.2g/kg/d for five days, and protein metabolism was measured on days 1, 3, and 5.', 'armGroupLabels': ['Moderate Protein Phase']}, {'name': 'Three day Controlled Diet', 'type': 'OTHER', 'description': 'Three days of a controlled diet providing 2.2g/kg/d of dietary protein with protein metabolism measured on day 3. This was used to model the habitual intake of this cohort.', 'armGroupLabels': ['Habitual Protein phase']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'M5S 2C9', 'city': 'Toronto', 'state': 'Ontario', 'country': 'Canada', 'facility': 'Goldring Centre for High Performance Sport', 'geoPoint': {'lat': 43.70643, 'lon': -79.39864}}], 'overallOfficials': [{'name': 'Daniel R Moore, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Toronto'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Toronto', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principle Investigator', 'investigatorFullName': 'Daniel Moore', 'investigatorAffiliation': 'University of Toronto'}}}}