Ignite Creation Date:
2025-12-25 @ 1:46 AM
Ignite Modification Date:
2026-03-08 @ 8:59 PM
Study NCT ID:
NCT07142694
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-08-27
First Post:
2025-07-10
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'This trial is a randomized controlled parallel arm feasibility trial'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-10-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-06', 'completionDateStruct': {'date': '2026-05-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-08-19', 'studyFirstSubmitDate': '2025-07-10', 'studyFirstSubmitQcDate': '2025-08-19', 'lastUpdatePostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-08-27', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-04-15', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Eligibility to Randomization Ratio for Feasibility', 'timeFrame': 'Measured upon study completion after 12-weeks', 'description': 'A ratio of eligibility to randomization will be collected at 12 months. The trial will be considered feasible if ratio falls within \\>0.5, calculated as the ratio of individuals who were randomized to the trial to the number eligible to participate who were approached to participate.'}, {'measure': 'Recruitment Rate', 'timeFrame': 'during 12 months', 'description': 'Recruitment rate will be assessed as the average number of new participants enrolled per site per week during the active recruitment period, with a target of ≥0.5 participants per site per week.'}, {'measure': 'Follow up rate', 'timeFrame': 'Measured at end of 12 weeks', 'description': 'Follow-up rate (% of participant outcomes) will be calculated if more than \\>85% of participant outcomes'}, {'measure': 'Adherence to Intervention', 'timeFrame': 'Measured at the end of 12 weeks', 'description': 'Adherence to plant based pudding intervention if more than (75% of dispensed plant based pudding protein is consumed)'}], 'secondaryOutcomes': [{'measure': 'Serum Pre-Albumin', 'timeFrame': 'Measured at Baseline Week 1 and at the end of 12 weeks.', 'description': 'Serum albumin is measured in grams per deciliter (g/dL)'}, {'measure': 'Blood Amino Acid Profile', 'timeFrame': 'Measured at Baseline Week 1 and at the end of week 12', 'description': 'blood amino acid profile'}, {'measure': 'Dry Weight', 'timeFrame': 'Measured at Baseline Week 1 and after the end of week 12', 'description': 'Changes in body weight (Kg)'}, {'measure': 'Waist Circumsference', 'timeFrame': 'Measured at Baseline Week 1 and after the end of week 12', 'description': 'Measured in cm'}, {'measure': 'Lean mass', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured in Kg'}, {'measure': 'Fat Mass', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured in Kg'}, {'measure': 'Physical function; Five rep chair stand time test', 'timeFrame': 'Measured at Baseline Week 1 and after the end of week 12', 'description': 'the amount of time it takes for a participant to get up out of a chair five times measured in seconds'}, {'measure': 'Blood Pressure', 'timeFrame': 'Measured at Baseline Week 1 and after the end of week 12', 'description': 'Systolic and Diastolic Blood Pressure Measured in mmHg'}, {'measure': 'Total Calories intake', 'timeFrame': 'Measured at Baseline Week 1 and after the end of week 12', 'description': 'Using RxFoods- Diet recall change in total calories measured in kcal/day'}, {'measure': 'Carbohydrates', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured as g/day'}, {'measure': 'Protein', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured as g/day'}, {'measure': 'Fat', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured as g/day'}, {'measure': 'Fiber (total dietary fiber)', 'timeFrame': 'At the baseline week 1 and at end of week 12', 'description': 'Measured as g/day'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Feasibility Studies', 'Nutrition Intervention']}, 'descriptionModule': {'briefSummary': 'The goal of this a 12-week randomized controlled parallel arm feasibility trial is to evaluate the feasibility and acceptability of incorporating a plant-based protein pudding into the diets of older adults who attend a medically managed fitness facility. The primary participant population includes older adults, aged 60 years and above, who are generally healthy and engaged in structured fitness programs.\n\nThe main questions it aims to answer are:\n\nIs a plant-based protein pudding acceptable and well-tolerated by older adults? Does regular consumption of the pudding support muscle health and overall well-being in this population?\n\nParticipants will:\n\nConsume a plant-based protein pudding as one arm daily for 7 days per week (experimental) and the other will continue their current lifestyle (control).\n\nThe experimental group will complete surveys or questionnaires to assess acceptability, taste, and ease of integration into daily meals.\n\nUndergo basic physical or health assessments (e.g., muscle function or strength evaluations) to evaluate potential effects.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '60 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Participant is willing and able to give informed consent for participation in the trial\n* Male or female aged ≥60 years\n* Actively attend the Wellness Institute (≥8 times in the past 28 days),\n\nExclusion Criteria:\n\n* Allergy to ingredients in the study treatment\n* Inability to consume treatment product\n* Inability to obtain written informed consent\n* Apart of any physical rehab program at WI (cardiac rehab, kidney fit, etc. )'}, 'identificationModule': {'nctId': 'NCT07142694', 'briefTitle': 'Feasibility of Adding a Plant-Based Protein Pudding to the Diet of Older Adults Who Attend a Medically Managed Fitness Facility', 'organization': {'class': 'NETWORK', 'fullName': 'Seven Oaks Hospital Chronic Disease Innovation Centre'}, 'officialTitle': 'Evaluation of a Plant-based Protein Pudding In Older Adults Attending a Medically Managed Fitness Facility', 'orgStudyIdInfo': {'id': 'HS26887 (B2025:025)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Plant Based Pudding', 'description': 'Participants will consume plant based pudding daily for 7 days per week', 'interventionNames': ['Dietary Supplement: Plant Based pudding']}, {'type': 'NO_INTERVENTION', 'label': 'Continue with their current lifestyle', 'description': 'Participants will continue with their current lifestyle without intervention'}], 'interventions': [{'name': 'Plant Based pudding', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Will consume one high protein plant based pudding daily for 7-days per week for 12 weeks', 'armGroupLabels': ['Plant Based Pudding']}]}, 'contactsLocationsModule': {'locations': [{'zip': 'R2V 3M3', 'city': 'Winnipeg', 'state': 'Manitoba', 'country': 'Canada', 'contacts': [{'name': 'Navdeep Tangri Tangri, MD,PhD', 'role': 'CONTACT', 'email': 'ntangri@sogh.mb.ca', 'phone': '204-631-3834'}, {'name': 'Rebecca Mollard Mollard, PhD', 'role': 'CONTACT', 'email': 'rmollard@sogh.mb.ca', 'phone': '204-631-3834'}, {'name': 'Navdeep Tangri Tangri, MD,PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Rebecca Mollard Mollard, PhD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Clara Bohm Bohm, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Chronic Disease Innovation Centre', 'geoPoint': {'lat': 49.8844, 'lon': -97.14704}}], 'centralContacts': [{'name': 'Navdeep Tangri Dr. Tangri, MD, PhD', 'role': 'CONTACT', 'email': 'ntangri@sogh.mb.ca', 'phone': '204-631-3834'}, {'name': 'Danah Alhattab Dr. Alhattab, MSc, PhD', 'role': 'CONTACT', 'email': 'dalhattab@sogh.mb.ca', 'phone': '204-631-3834'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Seven Oaks Hospital Chronic Disease Innovation Centre', 'class': 'NETWORK'}, 'responsibleParty': {'type': 'SPONSOR'}}}}