Actively Recruiting
Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in Older Adults with Sarcopenia A Randomized Study of Protein Supplementation
Led by Nuritas Ltd · Updated on 2026-01-07
75
Participants Needed
2
Research Sites
68 weeks
Total Duration
On this page
Sponsors
N
Nuritas Ltd
Lead Sponsor
M
Medifood Hungary Innovation Kft
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are investigating the effects of MediDrink Platinum+, which contains a novel protein blend called SPR-01, alone or combined with PeptiStrong, a fava bean protein hydrolysate, on general fitness in older adults aged 60 and above who are malnourished and have sarcopenia. This multicenter, randomized study aims to measure improvements in physical function and overall well-being in this population using tools like the Barthel Index. Additional outcomes include hand grip strength, physical performance tests, and changes in fat-free body mass. The study uses a "Y" design where all 75 participants first consume a base formula (MediDrink Platinum) for 2 weeks. After this, they are randomly assigned to one of two groups for 10 weeks: one group receives SPR-01 alone at a personalized dose providing at least 1200 kcal/day, while the other group receives SPR-01 plus PeptiStrong at a dose of at least 1200 kcal/day and 2.4 g/day, respectively. This design allows comparison of the effects of the protein blend with and without the additional supplement. During the study, participants will be assessed on general well-being and fitness, mainly through the Barthel Index over weeks 0 to 12. Other measures include tests of muscle strength and physical function. Participants need to be able to eat orally, walk independently, and complete health questionnaires. The study monitors safety and treatment effects throughout the 12-week period.
CONDITIONS
Official Title
The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 60 years or older
- Body mass index (BMI) of 25 kg/m² or less
- Malnourished with mini nutritional assessment (MNA) score less than 11
- Sarcopenic with SARC-F score 4 or higher
- Able to eat orally, either alone or with assistance
- Able to walk independently with WHO performance status or ECOG 0-3
- Able to complete questionnaires and self-assess health status
- Able to provide informed consent
You will not qualify if you...
- Unable to eat food orally
- Having an acute infection
- Proven intestinal obstruction
- Having co-morbidities requiring special diet such as diabetes or kidney disease
- Liver dysfunction
- Acute or chronic kidney failure
- Uncontrollable nausea or vomiting
- Use of megestrol acetate or metabolic steroids
- Use of dietary supplements in the last 3 months
- Known allergy or intolerance to the study products
- Participation in another clinical trial within the last 3 months
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Országos Korányi Pulmonológiai Intézet
Budapest, Hungary, 1121
Actively Recruiting
2
Sóstói Szivárvány Idősek Otthona
Nyíregyháza, Hungary, 4431
Actively Recruiting
Research Team
E
Edit Nadasi, MD, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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