Ignite Creation Date:
2026-03-26 @ 3:19 PM
Ignite Modification Date:
2026-03-31 @ 5:12 AM
Study NCT ID:
NCT07393360
Status:
RECRUITING
Last Update Posted:
2026-03-23
First Post:
2025-12-29
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2026-03-25'}, 'conditionBrowseModule': {'meshes': [{'id': 'D009765', 'term': 'Obesity'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D015431', 'term': 'Weight Loss'}], 'ancestors': [{'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'}, {'id': 'D001836', 'term': 'Body Weight Changes'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR'], 'maskingDescription': 'Active product and placebo are indistinguishable in appearance, packaging, and administration schedule.'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 144}}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2025-12-11', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2026-01', 'completionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2026-03-20', 'studyFirstSubmitDate': '2025-12-29', 'studyFirstSubmitQcDate': '2026-01-30', 'lastUpdatePostDateStruct': {'date': '2026-03-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2026-02-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2026-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in Appendicular Skeletal Muscle Mass (ASMM)', 'timeFrame': 'Baseline, Week 8, Week 16, Week 24', 'description': 'ASMM will be assessed using Bioelectrical Impedance Vector Analysis (BIVA). The primary endpoint is the change in ASMM from baseline to Week 24 to determine whether the Food for Special Medical Purposes (FSMP) preserves skeletal muscle mass compared with placebo.'}], 'secondaryOutcomes': [{'measure': 'Handgrip Strength', 'timeFrame': 'Baseline, Week 8, Week 16, Week 24', 'description': 'Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function.'}, {'measure': 'Change in Fat-Free Mass (FFM)', 'timeFrame': 'Baseline, Week 8, Week 16, Week 24', 'description': 'Change in Fat-Free Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output.'}, {'measure': 'Change in Fat Mass (FM)', 'timeFrame': 'Baseline, Week 8, Week 16, Week 24', 'description': 'Change in Fat Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output.'}, {'measure': 'Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36)', 'timeFrame': 'Baseline, Week 8, Week 16, Week 24', 'description': 'The Short Form-36 Health Survey (SF-36) assesses physical and mental health-related quality of life.\n\nThe scale consists of 36 items scored into 8 domains. Each domain score ranges from 0 to 100, where higher scores indicate better health status.\n\nDomains include: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health.'}, {'measure': 'Change in Body Weight (kg)', 'timeFrame': 'Baseline to Week 24', 'description': 'Change in body weight measured in kilograms from baseline to Week 24. Continuous variable reported according to standard clinical procedures.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Weight Loss', 'Muscle Mass Preservation', 'Obesity', 'Body Composition', 'BIVA'], 'conditions': ['Obesity & Overweight']}, 'descriptionModule': {'briefSummary': 'This study evaluates whether a Food for Special Medical Purposes (FSMP) can help to preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists. Participants will receive the FSMP or a matching placebo for 24 weeks while continuing standard GLP-1-based therapy. ASMM will be measured using Bioelectrical Impedance Vector Analysis (BIVA).', 'detailedDescription': 'This randomized, double-blind, placebo-controlled investigates whether a Food for Special Medical Purposes (FSMP) can help preserve appendicular skeletal muscle mass (ASMM) in adults undergoing weight loss treatment with GLP-1 receptor agonists or dual GIP/GLP-1 receptor agonists.\n\nEligible participants are adults with obesity or overweight with comorbidities who are initiating GLP-1-based therapy as part of standard clinical management. Participants are randomized in a 1:1 ratio to receive either the FSMP or a matching placebo for 24 weeks, in addition to their ongoing GLP-1 RA or dual GIP/GLP-1 RA therapy. Study visits occur at baseline, 8 weeks, 16 weeks, and 24 weeks.\n\nThis trial aims to determine whether targeted nutritional support can mitigate the loss of lean mass commonly observed during pharmacologically assisted weight loss, thereby improving functional outcomes and overall patient well-being.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Age ≥18 years and ≤ 65 years old;\n* BMI ≥ 30 Kg/m2 and ≤45 kg/m2\n* BMI from 27 kg/m2 to 30 Kg/m2 with at least one associated co-morbidity related to overweight \\[e.g. dysglycemia (pre-diabetes and/or metabolic syndrome), hypertension, dyslipidemia, obstructive sleep apnea syndrome (OSAS\\], or cardiovascular disease\\]\n* Starting to use a GLP-1 RAs (liraglutide, semaglutide) or dual GIP and GLP-1 RAs (tirzepatide) for weight reduction; patient can be enrolled if they start the treatment at the time of enrollment or up to 2 weeks\n* Diet composition adjusted to provide 0.9-1.1 g/Kg ideal body weight proteins\n* Signed informed consent\n\nExclusion Criteria:\n\n* Type I and Type II diabetes; patients with pre-diabetes and/or metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled\n* Monogenic obesity (Subjects with a known diagnosis of monogenic obesity, including but not limited to pathogenic mutations in LEP, LEPR, MC4R, POMC, PCSK1, or other genes known to cause monogenic forms of early-onset or syndromic obesity)\n* Reduced kidney function, defined as eGFR \\< 60 mL/min/1.73 m², calculated using the CKD-EPI equation (see Appendix 1)\n* Oncologic patients in active treatments\n* Hypersensitivity to any of the constituents of the study product\n* Pregnancy\n* Breastfeeding\n* Use of meal replacements for a diet enriched with aminoacids and/or HMB\n* Use of food supplements containing aminoacids and/or HMB; patients can be included in the study if they undergo a washout period of at least 15 days'}, 'identificationModule': {'nctId': 'NCT07393360', 'acronym': 'MYO-PRESERVE', 'briefTitle': 'Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment', 'organization': {'class': 'INDUSTRY', 'fullName': 'Pharmanutra S.p.a.'}, 'officialTitle': 'Evaluating the Effect of a Food for Special Medical Purposes Containing Essential Amino Acids (EAA), Carnitine, Arginine, and Sucrosomial Minerals on the Preservation of Appendicular Skeletal Muscle Mass (ASMM) During a Weight Loss Program With GLP-1 Receptor Agonists', 'orgStudyIdInfo': {'id': 'MYO-PRESERVE'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myosave®', 'description': 'Participants receive Myosave® twice daily (two sachets/day) for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.', 'interventionNames': ['Dietary Supplement: Myosave®']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy.', 'interventionNames': ['Other: Placebo']}], 'interventions': [{'name': 'Myosave®', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks.', 'armGroupLabels': ['Myosave®']}, {'name': 'Placebo', 'type': 'OTHER', 'description': 'Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '20145', 'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Simona Bertoli, Prof.', 'role': 'CONTACT', 'email': 'simona.bertoli@unimi.it', 'phone': '+39 349 8130845'}, {'name': 'Simona Bertoli, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Auxologico', 'geoPoint': {'lat': 42.78235, 'lon': 12.59836}}, {'zip': '00163', 'city': 'Roma', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Massimiliano Caprio, Prof.', 'role': 'CONTACT', 'email': 'massimiliano.caprio@sanraffaele.it', 'phone': '+39 06 52253419'}, {'name': 'Massimiliano Caprio, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS San Raffaele', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '20089', 'city': 'Rozzano', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Roberto Vettor, Prof.', 'role': 'CONTACT', 'email': 'roberto.vettor@humanitas.it', 'phone': '+39 3356108167'}, {'name': 'Roberto Vettor, Prof.', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'IRCCS Istituto Clinico Humanitas', 'geoPoint': {'lat': 45.38193, 'lon': 9.1559}}], 'centralContacts': [{'name': 'Maria Sole Rossato', 'role': 'CONTACT', 'email': 'ms.rossato@pharmanutra.it', 'phone': '+390507846500'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Pharmanutra S.p.a.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Sintesi Research Srl', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}