Ignite Creation Date:
2025-12-24 @ 2:31 PM
Ignite Modification Date:
2026-01-08 @ 3:27 AM
Study NCT ID:
NCT03907059
Status:
COMPLETED
Last Update Posted:
2019-04-09
First Post:
2019-04-05
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Plant-based Dietary Protein and Resistance-training Adaptations
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006984', 'term': 'Hypertrophy'}], 'ancestors': [{'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067816', 'term': 'Whey Proteins'}, {'id': 'D030262', 'term': 'Soybean Proteins'}], 'ancestors': [{'id': 'D008894', 'term': 'Milk Proteins'}, {'id': 'D000080224', 'term': 'Animal Proteins, Dietary'}, {'id': 'D004044', 'term': 'Dietary Proteins'}, {'id': 'D011506', 'term': 'Proteins'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000067796', 'term': 'Whey'}, {'id': 'D008892', 'term': 'Milk'}, {'id': 'D003611', 'term': 'Dairy Products'}, {'id': 'D005502', 'term': 'Food'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D019602', 'term': 'Food and Beverages'}, {'id': 'D010940', 'term': 'Plant Proteins'}, {'id': 'D014674', 'term': 'Plant Proteins, Dietary'}, {'id': 'D045730', 'term': 'Soy Foods'}, {'id': 'D000067075', 'term': 'Vegetable Products'}, {'id': 'D014675', 'term': 'Vegetables'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 38}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-03-31', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-04', 'completionDateStruct': {'date': '2018-10-19', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-04-05', 'studyFirstSubmitDate': '2019-04-05', 'studyFirstSubmitQcDate': '2019-04-05', 'lastUpdatePostDateStruct': {'date': '2019-04-09', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-04-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2018-10-16', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Muscle cross-sectional area', 'timeFrame': '12 weeks', 'description': 'assessed by mode-B ultrasound'}, {'measure': 'Muscle strength', 'timeFrame': '12 weeks', 'description': 'assessed by leg-press one-maximum-repetition'}], 'secondaryOutcomes': [{'measure': 'Leg lean mass', 'timeFrame': '12 weeks', 'description': 'assessed by Dual-energy X-ray absorptiometry'}, {'measure': 'fiber cross-sectional area', 'timeFrame': '12 weeks', 'description': 'assessed by muscle biopsy (vastus lateralis)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['protein source', 'hypertrophy', 'resistance training', 'plant-based protein', 'omnivorous'], 'conditions': ['Healthy']}, 'referencesModule': {'references': [{'pmid': '33599941', 'type': 'DERIVED', 'citation': 'Hevia-Larrain V, Gualano B, Longobardi I, Gil S, Fernandes AL, Costa LAR, Pereira RMR, Artioli GG, Phillips SM, Roschel H. High-Protein Plant-Based Diet Versus a Protein-Matched Omnivorous Diet to Support Resistance Training Adaptations: A Comparison Between Habitual Vegans and Omnivores. Sports Med. 2021 Jun;51(6):1317-1330. doi: 10.1007/s40279-021-01434-9. Epub 2021 Feb 18.'}]}, 'descriptionModule': {'briefSummary': 'Dietary protein consumption maximizes the anabolic response during resistance training (RT) by triggering muscle protein synthesis and providing the indispensable amino acids for a net positive protein balance. Leucine is considered the key amino acid in this process, suggesting that differences in protein quality may influence RT-induced gains in muscle mass and strength. In general, plant-based protein sources have lower leucine concentrations than animal-based protein sources and human skeletal muscle. In this respect, despite acute evidence on lower anabolic properties of plant- vs. animal-based protein, the effects of an exclusive plant-based dietary protein diet on RT-induced adaptations are currently unknown.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Healthy young men\n* Vegans ≥ 1 y or omnivorous subjects\n* Physically active but no resistance-trained subjects\n* Without any chronic injury that impairs resistance training performance\n* Protein intake \\> 0.8 g/protein/kg body weight\n\nExclusion Criteria:\n\n* Use of creatine or beta-alanine supplements for the last 3 months\n* Use of proteins and/or amino acids supplements for the last 1 month\n* Engagement in specific dietary restrictions\n* Previous use of anabolic steroids\n* Engagement in any training program'}, 'identificationModule': {'nctId': 'NCT03907059', 'briefTitle': 'Plant-based Dietary Protein and Resistance-training Adaptations', 'organization': {'class': 'OTHER', 'fullName': 'University of Sao Paulo'}, 'officialTitle': 'Does Exclusive Consumption of Plant-based Dietary Protein Impair Resistance Training-induced Muscle Adaptations?', 'orgStudyIdInfo': {'id': '54014116.9.0000.5391'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Omnivorous', 'description': 'Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (whey) + 12 weeks of resistance training', 'interventionNames': ['Dietary Supplement: whey protein']}, {'type': 'EXPERIMENTAL', 'label': 'Vegan', 'description': 'Interventions: Daily protein intake was adjusted to 1.6g/kg/day via supplementation (soy) + 12 weeks of resistance training', 'interventionNames': ['Dietary Supplement: soy protein']}], 'interventions': [{'name': 'whey protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'supplementation individually adjusted to 1.6g/kg/day', 'armGroupLabels': ['Omnivorous']}, {'name': 'soy protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'supplementation individually adjusted to 1.6g/kg/day', 'armGroupLabels': ['Vegan']}]}, 'contactsLocationsModule': {'locations': [{'zip': '05508-030', 'city': 'São Paulo', 'state': 'São Paulo', 'country': 'Brazil', 'facility': 'University of Sao Paulo', 'geoPoint': {'lat': -23.5475, 'lon': -46.63611}}], 'overallOfficials': [{'name': 'Hamilton Roschel, Professor', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Sao Paulo'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Sao Paulo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Bruno Gualano', 'investigatorAffiliation': 'University of Sao Paulo'}}}}