MediDrink Platinum+ with a new fava bean protein and optional PeptiStrong to improve fitness in older adults with sarcopenia

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a multicentre, randomized active-control study enrolling 75 malnourished, sarcopenic adults aged 60+ using a 'Y' design where everyone starts on the base MediDrink Platinum formula for two weeks and then is randomized to receive the SRP-01 protein blend alone (n=37) or SRP-01 plus PeptiStrong (n=38) for 10 weeks. Dosing is individualized but provides at least 1200 kcal/day from the drink, with PeptiStrong dosed at 2.4 g/day when used. The primary outcome is change in general fitness measured by the Barthel Index, with secondary endpoints including hand-grip strength, the timed up-and-go test, and changes in fat-free body mass. The trial is sponsored by Nuritas Ltd in collaboration with Medifood Hungary and conducted at sites in Hungary.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 60 years or older
* BMI ≤ 25 kg/m²
* Malnourished (mini nutritional assessment MNA \<11
* Sarcopenic: SARC-F score ≥ 4
* Capable or oral feeding either alone or assisted
* Ambulatory (WHO PS/ECOG 0-3)
* Ability to complete questionnaires and self assess health status
* Ability to provide consent

Exclusion Criteria:

* Patient cannot eat orally
* Acute Infection
* Proven Intestinal obstruction
* Co-morbidities requiring a special diet (diabetes, kidney disease etc.)
* Liver dysfunction
* Acute or chronic renal failure
* Uncontrollable nausea or vomiting
* Use of megestrol acetate or metabolic steroids
* Dietary supplement use in the last 3 months
* Known intolerance or allergy to the investigational products
* Participation in any clinical trial within the last 3 months

Where it's running

• Országos Korányi Pulmonológiai Intézet
  Budapest, Hungary Recruiting
• Sóstói Szivárvány Idősek Otthona
  Nyíregyháza, Hungary Recruiting

Study contacts

• Study coordinator: Edit Nadasi, MD, PhD
• Email: clinicaltrials@medifoodinternational.com
• Phone: +36 20 251 1762

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.