Actively Recruiting

Phase Not Applicable
Age: 60Years +
All Genders
ID07322653

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

Age: 60Years +
All Genders

Eligibility Criteria

Eligible

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
Not Eligible

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

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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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