Ignite Creation Date:
2025-12-24 @ 4:44 PM
Ignite Modification Date:
2025-12-27 @ 12:04 AM
Study NCT ID:
NCT05809466
Status:
COMPLETED
Last Update Posted:
2025-04-01
First Post:
2023-03-14
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D055948', 'term': 'Sarcopenia'}, {'id': 'D010024', 'term': 'Osteoporosis'}], 'ancestors': [{'id': 'D009133', 'term': 'Muscular Atrophy'}, {'id': 'D020879', 'term': 'Neuromuscular Manifestations'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D009422', 'term': 'Nervous System Diseases'}, {'id': 'D001284', 'term': 'Atrophy'}, {'id': 'D020763', 'term': 'Pathological Conditions, Anatomical'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D001851', 'term': 'Bone Diseases, Metabolic'}, {'id': 'D001847', 'term': 'Bone Diseases'}, {'id': 'D009140', 'term': 'Musculoskeletal Diseases'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000067269', 'term': 'Diet, Vegan'}, {'id': 'D055070', 'term': 'Resistance Training'}], 'ancestors': [{'id': 'D014676', 'term': 'Diet, Vegetarian'}, {'id': 'D000095500', 'term': 'Diet, Plant-Based'}, {'id': 'D004035', 'term': 'Diet Therapy'}, {'id': 'D044623', 'term': 'Nutrition Therapy'}, {'id': 'D013812', 'term': 'Therapeutics'}, {'id': 'D004032', 'term': 'Diet'}, {'id': 'D009747', 'term': 'Nutritional Physiological Phenomena'}, {'id': 'D000066888', 'term': 'Diet, Food, and Nutrition'}, {'id': 'D010829', 'term': 'Physiological Phenomena'}, {'id': 'D005081', 'term': 'Exercise Therapy'}, {'id': 'D012046', 'term': 'Rehabilitation'}, {'id': 'D000359', 'term': 'Aftercare'}, {'id': 'D003266', 'term': 'Continuity of Patient Care'}, {'id': 'D005791', 'term': 'Patient Care'}, {'id': 'D026741', 'term': 'Physical Therapy Modalities'}, {'id': 'D064797', 'term': 'Physical Conditioning, Human'}, {'id': 'D015444', 'term': 'Exercise'}, {'id': 'D009043', 'term': 'Motor Activity'}, {'id': 'D009068', 'term': 'Movement'}, {'id': 'D009142', 'term': 'Musculoskeletal Physiological Phenomena'}, {'id': 'D055687', 'term': 'Musculoskeletal and Neural Physiological Phenomena'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'PREVENTION', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 72}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-04-04', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-11', 'completionDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-03-25', 'studyFirstSubmitDate': '2023-03-14', 'studyFirstSubmitQcDate': '2023-03-29', 'lastUpdatePostDateStruct': {'date': '2025-04-01', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-04-12', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-09-26', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Change in body weight', 'timeFrame': 'Change after 10 days and after 12 weeks', 'description': 'Body weight (kg) will be measured in a fasted state using a calibrated digital scale'}], 'primaryOutcomes': [{'measure': 'Change in thigh muscle volume', 'timeFrame': '12 weeks', 'description': 'Thigh muscle volume of both legs will be assessed using magnetic resonance imaging before and after the 3-month intervention'}], 'secondaryOutcomes': [{'measure': 'Body composition', 'timeFrame': 'Change after 12 weeks', 'description': 'Other body composition indices will also be measured using magnetic resonance imaging before and after the intervention. These indices include: liver fat fraction, thigh muscle fat infiltration, abdominal subcutaneous adipose tissue, visceral fat tissue.'}, {'measure': 'Change in muscle strength', 'timeFrame': 'Change after 12 weeks', 'description': 'Maximal isometric knee extension and flexion strength of both legs will be measured using Biodex.'}, {'measure': 'Muscle fractional synthesis rates', 'timeFrame': '10 days', 'description': 'Muscle fractional synthesis rates, expressed as daily fractional synthesis rates (FSR, %/day), will be assessed using a deuterium oxide protocol. Daily FSR will be calculated using the 2\\^H-alanine enrichment in plasma and the mixed muscle-bound 2\\^H-alanine enrichment.'}, {'measure': 'Change in bone mineral density', 'timeFrame': 'Change after 12 weeks', 'description': 'Measured using a Dual X-Ray Absorptiometry dual femur scan'}, {'measure': 'Change in fasting bone turnover markers', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Serum procollagen type I N-terminal propeptide (P1NP) will be measured for bone formation and C-terminal telopeptide of type I collagen (CTX) for bone resorption.'}, {'measure': 'Change in plasma insulin growth factor 1 levels', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting serum insulin-like growth factor 1 (IGF-1)'}, {'measure': 'Change in plasma parathyroid hormone (PTH) levels', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting plasma PTH'}, {'measure': 'Change in fasting plasma insulin levels', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting plasma insulin'}, {'measure': 'Change in metabolic profile', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting plasma levels of multiple metabolites'}, {'measure': 'Change in fasting blood pressure', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting systolic and diastolic blood pressure'}, {'measure': 'Change in haemoglobin levels', 'timeFrame': 'Change after 12 weeks', 'description': 'Fasting plasma haemoglobin levels'}, {'measure': 'Change in vitamin B12 status', 'timeFrame': 'Change after 12 weeks', 'description': 'Fasting plasma methylmalonic acid levels'}, {'measure': 'Change in vitamin D status', 'timeFrame': 'Change after 12 weeks', 'description': 'Fasting serum vitamin D levels'}, {'measure': 'Change in gastro-intestinal symptoms', 'timeFrame': 'Change after 12 weeks', 'description': 'Self-reported gastro-intestinal symptoms using the gastro-intestinal symptom rating scale. The questionnaire includes 15 questions covering 5 common symptom clusters on a 7-point likert scale ranging from no symptoms (minimum) to severe symptoms (maximum). A higher score indicates worse symptoms.'}, {'measure': 'Untargeted gut metabolomics', 'timeFrame': 'Change after 12 weeks', 'description': 'Untargeted gut metabolomics will be performed on fasting plasma samples'}, {'measure': 'Change in fasting plasma high-sensitive C-reactive protein (hs-CRP)', 'timeFrame': 'Change after 6 and 12 weeks', 'description': 'Fasting plasma hs-CRP'}, {'measure': 'Change in ferritin levels', 'timeFrame': 'Change after 12 weeks', 'description': 'Fasting plasma ferritin levels'}, {'measure': 'Tryptophan', 'timeFrame': 'Change after 12 weeks', 'description': 'Tryptophan will be assessed using targeted metabolomics on plasma samples'}, {'measure': 'Tyrosine', 'timeFrame': 'Change after 12 weeks', 'description': 'Tyrosine will be assessed using targeted metabolomics on plasma samples'}, {'measure': 'Branch-chained amino acids', 'timeFrame': 'Change after 12 weeks', 'description': 'Branch-chained amino acids will be assessed using targeted metabolomics on plasma samples'}, {'measure': 'Oxidized amino acids', 'timeFrame': 'Change after 12 weeks', 'description': 'Oxidized amino acids will be assessed using targeted metabolomics on plasma samples'}, {'measure': 'Gut metagenomics', 'timeFrame': 'Change after 12 weeks', 'description': 'Microbial DNA will be isolated from the feces samples. The taxonomy and function of specific genes will be assessed via metagenomic sequencing on the microbial DNA.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vegan Diet', 'Sarcopenia', 'Cardiovascular Health', 'Osteoporosis', 'Gut Health']}, 'descriptionModule': {'briefSummary': 'Consumers are increasingly encouraged to consume more plant-based foods and lower their consumption of foods from animal origin. This shift is driven by environmental and health factors. However, the consequences of such a transition on muscle mass still remains to be explored. This is of particular importance in the older population, where the age-related reduction in muscle mass and strength is highly prevalent. Adequate dietary intake, specifically protein intake, is a well-known strategy in promoting muscle mass in older adults. Plant-based foods are currently considered to be inferior to animal-based foods in their protein quality, and are therefore considered to be suboptimal for the maintenance of muscle mass at an older age. On the other hand, combining plant-based foods may improve the protein quality and thereby the anabolic properties of a vegan meal. Evidence regarding the anabolic properties of vegan diets in older adults is scarce. As such, the current study aims to assess 1) the effects of a 12-week self-composed vegan diet in comparison to an omnivorous diet on thigh muscle volume (TMV) in community-dwelling older adults and 2) the effect of a 12-week self-composed vegan diet combined with twice-weekly resistance exercise (RE) on TMV in comparison to a self-composed vegan diet without resistance exercise in community-dwelling older adults.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['OLDER_ADULT'], 'minimumAge': '65 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged ≥65 years old;\n* Community-dwelling;\n* BMI 23-32 kg/m2;\n* Habitual diet contains animal-based food products (i.e. dairy, meat and/or fish) at least 5 days per week;\n\nExclusion Criteria:\n\n* Following a self-reported entirely vegetarian or vegan diet during the six months prior to the study;\n* Following a prescribed high (≥1.2 g/kg/d) or low protein diet (\\<0.8 g/kg/d), and/or or taking protein supplements on medical advice, during the month prior to the study;\n* Participating in a structured progressive resistance exercise training program the during three months prior to the study;\n* ≥4 kg of body weight loss during three months before the start of the study;\n* Being diagnosed with one of the following: diabetes mellitus; renal disease; neurological or neuromuscular disorders; serious cardiovascular diseases; cancer (with the exception of the following types of skin cancer: basal cell carcinoma, squamous cell carcinoma); (very) severe chronic obstructive lung disease (COPD; GOLD stage III or IV); bowel disease.\n* Chronic use of medication that affects muscle function as assessed by the research physician;\n* The use of anticoagulants incompatible for muscle biopsies as assessed by the research physician: acenocoumarol (sintrom); phenprocoumon (marcoumar); dabigatran (pradaxa); apixaban (eliquis); rivaroxaban (xarelto); clopidogrel (plavix); edoxaban (lixiana); combination of acetylsalicylic acid or carbasalate calcium (ascal) with dipyridamole;\n* Having a contra-indication to MRI scanning (including, but not limited to):\n\n * Pacemakers and defibrillators\n * Infraorbital or intraocular metallic fragments\n * Ferromagnetic implants\n * Claustrophobia\n* Having a hip prosthesis\n* Not willing to stop nutritional supplements, with the exception of supplements on medical advice, and vitamin D;\n* Not willing or afraid to give blood, undergo a muscle biopsy or have an MRI scan during the study;\n* Unwilling to eat a self-composed vegan diet or an omnivorous diet with daily consumption of animal-based food sources for 3 months;\n* Unwilling to participate in RE twice a week for 3 months;\n* Currently a research participant in another trial or participated in a clinical trial during one month before the start of the measurement period;\n* Not being able to understand Dutch;\n* Not having a general physician;\n* Working, or having a direct family member that work at the Division of Human Nutrition at Wageningen University during the study.\n* Unwilling to be informed about incidental findings of pathology and approving of reporting this to their general physician.'}, 'identificationModule': {'nctId': 'NCT05809466', 'acronym': 'Vold', 'briefTitle': 'The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults', 'organization': {'class': 'OTHER', 'fullName': 'Wageningen University'}, 'officialTitle': 'The Effect of a 12-week Self-composed Vegan Diet With or Without Concurrent Resistance Exercise on Thigh Muscle Volume in Older Adults', 'orgStudyIdInfo': {'id': 'NL82788.091.22'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Vegan group', 'interventionNames': ['Other: Vegan diet']}, {'type': 'EXPERIMENTAL', 'label': 'Vegan group with resistance exercise', 'interventionNames': ['Other: Vegan diet', 'Other: Resistance exercise']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Omnivorous group', 'interventionNames': ['Other: Omnivorous diet']}], 'interventions': [{'name': 'Vegan diet', 'type': 'OTHER', 'description': 'A self-composed 12 week fully plant-based diet', 'armGroupLabels': ['Vegan group', 'Vegan group with resistance exercise']}, {'name': 'Resistance exercise', 'type': 'OTHER', 'description': 'Biweekly resistance exercise for 12 weeks', 'armGroupLabels': ['Vegan group with resistance exercise']}, {'name': 'Omnivorous diet', 'type': 'OTHER', 'description': 'Habitual diet containing both animal- and plant-based food products', 'armGroupLabels': ['Omnivorous group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '6708 WE', 'city': 'Wageningen', 'state': 'Gelderland', 'country': 'Netherlands', 'facility': 'Wageningen University and Research', 'geoPoint': {'lat': 51.97, 'lon': 5.66667}}], 'overallOfficials': [{'name': 'Lisette de Groot, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Wageningen University and Research'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Wageningen University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Prof. Dr. Ir. L.C.P.G.M. (Lisette) de Groot', 'investigatorFullName': 'Lisette de Groot', 'investigatorAffiliation': 'Wageningen University'}}}}