رادار التجارب AI | ||
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حالة التجربة السريرية NCT07393360 (MYO-PRESERVE) لـ Obesity & Overweight هي يقبل مشاركين. اطلعوا على جميع التفاصيل في عرض البطاقة الخاص برادار التجارب السريرية وأدوات اكتشاف الذكاء الاصطناعي. أو يمكنكم طرح أي سؤال هنا. | ||
دراسة واحدة تطابق معايير الفلتر
عرض البطاقة
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment (MYO-PRESERVE) ١٤٤
تفاصيل التجربة السريرية متاحة بشكل أساسي باللغة الإنجليزية. ومع ذلك، يمكن لـ رادار التجارب AI مساعدتك؛ ما عليك سوى النقر على «وصف الدراسة» لعرض ومناقشة معلومات الدراسة باللغة التي اخترتها.
التجربة السريرية NCT07393360 (MYO-PRESERVE) هي دراسة تدخُّلية لـObesity & Overweight وهي يقبل مشاركين. بدأت في ٢٠ جمادى الآخرة ١٤٤٧ هـ مع خطة لتجنيد ١٤٤ مشاركًا. يقودها Pharmanutra S.p.a.، ومن المتوقع اكتمالها بحلول ٢١ جمادى الآخرة ١٤٤٨ هـ. تم تحديث البيانات الأخيرة من ClinicalTrials.gov في ٤ شوال ١٤٤٧ هـ.
الملخص
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 A...عرض المزيد
وصف مفصل
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.
Eligible participants are adults with obesity or overweight with comorbidities who are initiating GLP-1-based therapy as part of standard...
عرض المزيدالعنوان الرسمي
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
الحالات الطبية
Obesity & Overweightمعرّفات دراسة أخرى
- MYO-PRESERVE
NCT معرّف
تاريخ البدء (فعلي)
2025-12-11
آخر تحديث مُنشور
2026-03-23
تاريخ الاكتمال (المقدر)
2026-12
عدد المشاركين المخطط لهم
١٤٤
نوع الدراسة
تدخُّلية
المرحلة
غ/م
الحالة
يقبل مشاركين
الكلمات الرئيسية
Weight Loss
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Muscle Mass Preservation
Obesity
Body Composition
BIVA
الغرض الأساسي
الرعاية الداعمة
طريقة توزيع المشاركين
عشوائي
نموذج التدخل
التصميم المتوازي
التعمية
رباعي
مجموعات/التدخلات
| مجموعة المشاركين/الذراع | التدخل/العلاج |
|---|---|
تجريبيةMyosave® 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. | Myosave® A Food for Special Medical Purposes. Two sachets per day (morning and afternoon), taken on an empty stomach for 24 weeks. |
مقارن بالدواء الوهميPlacebo Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy. | دواء وهمي Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks |
النتيجة الرئيسية
النتيجة الثانوية
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Change in Appendicular Skeletal Muscle Mass (ASMM) | 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. | Baseline, Week 8, Week 16, Week 24 |
| مقياس النتيجة | وصف القياس | الإطار الزمني |
|---|---|---|
Handgrip Strength | Handgrip strength will be measured with a calibrated dynamometer on both dominant and non-dominant hands to evaluate changes in muscle function. | Baseline, Week 8, Week 16, Week 24 |
Change in Fat-Free Mass (FFM) | Change in Fat-Free Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output. | Baseline, Week 8, Week 16, Week 24 |
Change in Fat Mass (FM) | Change in Fat Mass measured using Bioelectrical Impedance Vector Analysis (BIVA). Continuous variable reported according to device output. | Baseline, Week 8, Week 16, Week 24 |
Change in Health-Related Quality of Life (Short Form-36 Health Survey, SF-36) | The Short Form-36 Health Survey (SF-36) assesses physical and mental health-related quality of life.
The scale consists of 36 items scored into 8 domains. Each domain score ranges from 0 to 100, where higher scores indicate better health status.
Domains include: Physical Functioning, Role Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role Emotional, and Mental Health. | Baseline, Week 8, Week 16, Week 24 |
Change in Body Weight (kg) | Change in body weight measured in kilograms from baseline to Week 24. Continuous variable reported according to standard clinical procedures. | Baseline to Week 24 |
مساعد المشاركة
معايير الأهلية
الأعمار المؤهلة للدراسة
بالغ, كبار السن
العمر الأدنى للدراسة
18 Years
الجنس المؤهل
الكل
- Age ≥18 years and ≤ 65 years old;
- BMI ≥ 30 Kg/m2 and ≤45 kg/m2
- 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]
- 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
- Diet composition adjusted to provide 0.9-1.1 g/Kg ideal body weight proteins
- Signed informed consent
- Type I and Type II diabetes; patients with pre-diabetes and/or metabolic syndrome and assuming Metformin and SGLT-2 inhibitors can be enrolled
- 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)
- Reduced kidney function, defined as eGFR < 60 mL/min/1.73 m², calculated using the CKD-EPI equation (see Appendix 1)
- Oncologic patients in active treatments
- Hypersensitivity to any of the constituents of the study product
- Pregnancy
- Breastfeeding
- Use of meal replacements for a diet enriched with aminoacids and/or HMB
- 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
Pharmanutra S.p.a.Sintesi Research Srlجهة اتصال مركزية للدراسة
جهة اتصال: Maria Sole Rossato, +390507846500, [email protected]
3 مواقع الدراسة في 1 بلدان
IRCCS Auxologico, Milan, 20145, Italy
Simona Bertoli, Prof., جهة اتصال, +39 349 8130845, [email protected]
Simona Bertoli, Prof., المحقق الرئيسي
يقبل مشاركين
IRCCS San Raffaele, Roma, 00163, Italy
Massimiliano Caprio, Prof., جهة اتصال, +39 06 52253419, [email protected]
Massimiliano Caprio, Prof., المحقق الرئيسي
يقبل مشاركين
IRCCS Istituto Clinico Humanitas, Rozzano, 20089, Italy
Roberto Vettor, Prof., جهة اتصال, +39 3356108167, [email protected]
Roberto Vettor, Prof., المحقق الرئيسي
يقبل مشاركين