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| ID | Type | Description | Link |
|---|---|---|---|
| GINOP PLUSZ 2.1.1-21-102200048 | Other Grant/Funding Number | GINOP PLUSZ |
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| Name | Class |
|---|---|
| Medifood Hungary Innovation Kft | UNKNOWN |
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Examining the effects of MediDrink Platinum+ containing novel protein blend SRP-01 alone or when combined with PeptiStrong on clinical responses in elderly adults with sarcopenia
The primary aim of this multicentre randomised active control group study , is to characterise the effect of MediDrink Platinum+ containing a novel protein blend SPR-01, alone and in combination with PeptiStrong on general fitness measured via the Barthel index in malnourished sarcopenic, adults, aged 60 and above. The trial will incorporate a "Y" design whereby all 75 participants begin on the base formula (MediDrink Platinum) for 2 weeks before being randomised into the SPR-01 alone (n=37, dose calculated per individual but at least 1200 kcal/day) or SP1-01 and PeptStrong (n=38, dose calculated per individual but at least 1200 kcal per day and 2.4g/day, respectively) supplementation arms for 10 weeks.
Other clinical endpoints measured as secondary endpoints will include hand grip strength, physical functioning via time up&go test and changes in fat-free body mass.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| MediDrink Platinum+ | Active Comparator | Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml) |
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| MediDrink Platinum+ and PeptiStrong | Experimental | Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml) and 2.4g/day PeptiStrong |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MediDrink Platinum+ | Other | MediDrink Platinum+ containing novel protein blend SPR-01 |
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| Measure | Description | Time Frame |
|---|---|---|
| General well-being via Barthel Index | Time to 5 point change in Barthel Index compared from baseline (visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. The Barthel scale measures the ability to perform basic activities of daily living using 10 variables describing mobility. A higher value is associated with a higher likelihood of independence | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Hand Grip Strength via Dynamometer | Change in hand grip strength compared from baseline (Visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| General well-being via Barthel Index (Active control Vs experimental) | Time to 5 point change in Barthel Index compared from week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. The Barthel scale measures the ability to perform basic activities of daily living using 10 variables describing mobility. A higher value is associated with a higher likelihood of independence |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Edit Nadasi, MD, PhD | Contact | +36 20 251 1762 | clinicaltrials@medifoodinternational.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Országos Korányi Pulmonológiai Intézet | Recruiting | Budapest | 1121 | Hungary |
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All participants begin on the base formula MediDrink Platinum before splitting into one of two arms, the version containing novel protein blend SPR-01, MediDrink Platinum+, or MediDrink Platinum+ and 2.4g of PeptiStrong supplement
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| MediDrink Platinum+ and PeptiStrong | Other | MediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate |
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| Fat-free body mass via bioelectrical impedance analysis |
Change in fat-free body mass compared from baseline (visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. |
| Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 |
| Functional performance via time up & go test | Change in time to up & go compared from baseline (visit 0) to week 2 in the whole patient population versus week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 |
| Week 2 to Week 12 |
| Hand Grip Strength via Dynamometer ( Active control Vs experimental) | Change in hand grip strength compared from week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. | Week 2 to Week 12 |
| Fat-free body mass via bioelectrical impedance analysis | Change in Fat-free body mass compared from week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. | Week 2 to Week 12 |
| Functional performance via time up & go test (Active control Vs experimental) | Change in time to up & go compared from week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. | Week 2 to Week 12 |
| Sóstói Szivárvány Idősek Otthona | Recruiting | Nyíregyháza | 4431 | Hungary |
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| ID | Term |
|---|---|
| D044342 | Malnutrition |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D012816 | Signs and Symptoms |
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