MediDrink Platinum+ with a new fava bean protein and optional PeptiStrong to improve fitness in older adults with sarcopenia
Prospective, Open-Label, Multicenter Study to Characterise the Effects of Co-administration of MediDrink Platinum+ Formula Containing Novel Protein Blend SPR-01 and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
This trial will see if MediDrink Platinum+ with a novel protein blend, given alone or together with PeptiStrong, improves fitness in malnourished adults aged 60 and older who have sarcopenia.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 75 (estimated) |
| Ages | 60 Years and up |
| Sex | All |
| Sponsor | Nuritas Ltd Industry-sponsored |
| Locations | 2 sites (Budapest and 1 other locations) |
| Trial ID | NCT07322653 on ClinicalTrials.gov |
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.
Who should consider this trial
Good fit: Ideal candidates are ambulatory adults aged 60 or older who are malnourished (MNA < 11), have sarcopenia (SARC-F ≥ 4), a BMI ≤ 25 kg/m², can eat orally, and can provide informed consent.
Not a fit: Patients who cannot eat orally, have acute infection, intestinal obstruction, uncontrolled liver or renal failure, co-morbidities requiring special diets (e.g., uncontrolled diabetes or advanced kidney disease), recent use of certain supplements or metabolic steroids, or known intolerance to the products are unlikely to benefit or are excluded.
Why it matters
Potential benefit: If successful, the intervention could improve daily functioning and muscle mass in malnourished older adults with sarcopenia, potentially lowering care needs and frailty.
How similar studies have performed: General protein supplementation has shown modest benefits for muscle mass and function in older adults, but the specific SRP-01 fava-bean blend and the PeptiStrong peptide combination are novel and not yet proven in large trials.
Eligibility criteria
Show full inclusion / exclusion criteria
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 this trial is running
Budapest and 1 other locations
- 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
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.