Ignite Creation Date:
2025-12-26 @ 1:19 PM
Ignite Modification Date:
2025-12-26 @ 1:19 PM
Study NCT ID:
NCT06461806
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2024-07-08
First Post:
2024-05-30
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Effect of Protein Source During Ketogenic Weight Loss Intervention
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}], 'ancestors': [{'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT'], 'maskingDescription': 'Participants are provided with unlabelled protein containers in this single-blind study.'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participant are randomized to a plant or animal protein based ketogenic diet for a 12 week period. They are provided with the plant or animal proteins which they consume in the form of a smoothie twice a day. The remaining meal comprises of self selected foods.'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 60}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2022-10-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-03', 'completionDateStruct': {'date': '2024-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2024-07-03', 'studyFirstSubmitDate': '2024-05-30', 'studyFirstSubmitQcDate': '2024-06-11', 'lastUpdatePostDateStruct': {'date': '2024-07-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2024-06-17', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-07-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in weight', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Overall weight loss, kg'}, {'measure': 'Change in BMI', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Height and weight will be combined to report BMI (kg/m\\^2)'}, {'measure': 'Change in fat mass', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Body composition is measured by dual energy x-ray absorptiometry.'}, {'measure': 'Change in overall body fat percentage', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Body composition is measured by dual energy x-ray absorptiometry.'}, {'measure': 'Regional subcutaneous adipose tissue immune cells ( number of cells per gram tissue, percentage of the stromal vascular compartment)', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Changes in various adipose tissue immune cells including M1-like and M2-like macrophages, T helper cells, and cytotoxic T cells will be measured via flow cytometry.'}, {'measure': 'Concentrations of Circulatory cytokines and adipokines', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Changes in cytokines and adipokines will be measured via ELISA. We will measure markers including interleukin 6, tumour necrosis factor a, leptin, and adiponectin.'}, {'measure': 'Resting energy expenditure', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Resting energy expenditure will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the resting energy expenditure.'}, {'measure': 'Substrate oxidation', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Substrate oxidation will be measured in a fasted state by indirect calorimetry. Volume of oxygen and carbon dioxide and water vapor pressure will be taken into consideration to calculate the respiratory exchange ratio.'}, {'measure': 'Lipidomics', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Lipidomics will be measured by mass spectrometry.'}, {'measure': 'Adipocyte size', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Regional adipocyte characteristics will be measured in vitro including adipocyte size,'}, {'measure': 'Rate of pre-adipocyte proliferation', 'timeFrame': 'Baseline and at 12 weeks', 'description': 'Regional adipose tissue pre-adipocyte proliferation rate will be measured in vitro'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Obesity', 'Obesity; Endocrine']}, 'descriptionModule': {'briefSummary': 'This randomized, controlled, single-blinded study will investigate how the protein source in a high-protein ketogenic diet affects metabolic weight loss outcomes after a 12-week dietary intervention', 'detailedDescription': 'This randomized, controlled, single-blinded study will compare how a ketogenic weight loss diet, supplemented with either animal- or plant-based protein affects: (i) metabolic markers (adipokine and cytokine) in adipose tissue and blood, (ii) adipose tissue immune cell profiles, and (iii) adipocyte characteristics and their interaction with other cells (e.g. immune cells and muscle cells). To better determine how tissue characteristics affect the whole body level, the relationships between adipose tissue characteristics and blood lipid and inflammatory markers will also be examined. Participants undergo anthropometric measurements, questionnaires, body composition assessment, energy assessment, blood draws, and adipose tissue biopsies from the abdominal and femoral adipose tissue depots'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults between 18-60 years old\n* BMI: \\>29.99kg/m2\n\nExclusion Criteria:\n\n* Any chronic metabolic conditions (e.g. CVD)\n* Renal impairment (creatinine clearance \\<60 mL/min)\n* Uncontrolled hypothyroidism\n* Pregnant, breastfeeding, or postmenopausal females\n* Past (\\<6 year) or present use of nicotine products\n* Use of cannabis products\n* Use of any other medications that may affect study outcomes (e.g. anti-depressants)\n* Participants who have had a number of CT scans in the course of the year\n* Participants following a vegan diet'}, 'identificationModule': {'nctId': 'NCT06461806', 'briefTitle': 'Effect of Protein Source During Ketogenic Weight Loss Intervention', 'organization': {'class': 'OTHER', 'fullName': 'Concordia University, Montreal'}, 'officialTitle': 'Effect of Protein Source During Ketogenic Weight Loss Intervention on Lipid Metabolism and Inflammation', 'orgStudyIdInfo': {'id': '90000185'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plant-based pea/lupine protein supplement', 'interventionNames': ['Dietary Supplement: Protein supplement - Plant protein']}, {'type': 'EXPERIMENTAL', 'label': 'Animal-based whey protein supplement', 'interventionNames': ['Dietary Supplement: Protein supplement - Animal protein']}], 'interventions': [{'name': 'Protein supplement - Plant protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Pea/lupine protein powder mix', 'armGroupLabels': ['Plant-based pea/lupine protein supplement']}, {'name': 'Protein supplement - Animal protein', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Whey protein powder', 'armGroupLabels': ['Animal-based whey protein supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'H4B 1R6', 'city': 'Montreal', 'state': 'Quebec', 'country': 'Canada', 'facility': 'School of Health, Concordia University', 'geoPoint': {'lat': 45.50884, 'lon': -73.58781}}], 'overallOfficials': [{'name': 'Sylvia Santsa, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Concordia University, Montreal'}]}, 'ipdSharingStatementModule': {'infoTypes': ['STUDY_PROTOCOL', 'SAP', 'ICF'], 'timeFrame': 'The data will be available after the study results have been accepted for publication. The data will be available for 5 y.', 'ipdSharing': 'YES', 'description': 'On request and approval by ethics', 'accessCriteria': 'On request with ethics approval.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Concordia University, Montreal', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}