治験レーダーAI | ||
|---|---|---|
治験 NCT07393360 (MYO-PRESERVE)（対象：Obesity & Overweight）は募集中です。詳細は治験レーダーのタイル表示と AI 発見ツールで確認するか、ここで質問してください。 | ||
フィルター基準に一致する試験が1件見つかりました
タイル表示
Effect of a Food for Special Medical Purposes on Muscle Mass Preservation During GLP-1 RAs Weight Loss Treatment (MYO-PRESERVE) 144
治験（臨床試験）の詳細は主に英語で提供されていますが、治験レーダーAIがサポートします！「治験解説」をクリックして、選択した言語で試験情報を表示し、議論してください。
治験番号 NCT07393360 (MYO-PRESERVE) は 介入研究 臨床試験 で、Obesity & Overweight に関するものです。現在は 募集中 で、2025年12月11日 から開始しています。144 名の参加者 の募集が計画されています。この試験は Pharmanutra S.p.a. によって主導され、2026年12月1日 に完了予定です。ClinicalTrials.gov からの最新更新日は 2026年3月23日 です。
概要
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...もっと見る
詳細説明
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...
もっと見る公式タイトル
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
疾患名
Obesity & Overweightその他の研究識別子
- MYO-PRESERVE
NCT番号
開始日
2025-12-11
最終更新日
2026-03-23
終了予定日
2026-12
目標参加者数
144
試験の種類
介入研究
治験の相・段階
該当なし
状況
募集中
キーワード
Weight Loss
Muscle Mass Preservation
Obesity
Body Composition
BIVA
Muscle Mass Preservation
Obesity
Body Composition
BIVA
主目的
支持療法
割付方法
無作為化
介入モデル
並行割当
盲検化
四重盲検
群（アーム）／介入
| 参加グループ/群 | 介入/治療法 |
|---|---|
実験的Myosave® 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. |
プラセボ対照薬Placebo Participants receive a matching placebo twice daily for 24 weeks, in addition to standard GLP-1 RA or dual GIP/GLP-1 RA therapy. | プラセボ Maching in appearance, taste, and dosing schedule to Myosave®. Two sachets per day for 24 weeks |
主要評価項目
副次評価項目
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
| 評価指標 | 指標の説明 | 時間枠 |
|---|---|---|
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 |
参加アシスタント
適格基準
対象年齢
成人, 高齢者
試験の最低年齢
18 Years
対象性別
全て
- 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 Srl試験中央連絡先
連絡先: Maria Sole Rossato, +390507846500, [email protected]
3 1カ国の場所
IRCCS Auxologico, Milan, 20145, Italy
Simona Bertoli, Prof., 連絡先, +39 349 8130845, [email protected]
Simona Bertoli, Prof., 主任研究者
募集中
IRCCS San Raffaele, Roma, 00163, Italy
Massimiliano Caprio, Prof., 連絡先, +39 06 52253419, [email protected]
Massimiliano Caprio, Prof., 主任研究者
募集中
IRCCS Istituto Clinico Humanitas, Rozzano, 20089, Italy
Roberto Vettor, Prof., 連絡先, +39 3356108167, [email protected]
Roberto Vettor, Prof., 主任研究者
募集中