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NCT Number: NCT07322653

The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population

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

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Key information

Conditions

Sarcopenia in Elderly Atrophy Malnourished Malnutrition Muscle Mass Muscular Atrophy Nervous System Diseases Neurologic Manifestations Neuromuscular Manifestations Nutrition Disorders Nutritional and Metabolic Diseases Pathological Conditions, Anatomical Pathological Conditions, Signs and Symptoms Physical Function Protein Supplementation Sarcopenia Signs and Symptoms Strength

Age range

60 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Országos Korányi Pulmonológiai Intézet, Budapest, Hungary

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About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MediDrink Platinum+

Other

MediDrink Platinum+ containing novel protein blend SPR-01

Other names: Clinical Nutrition

MediDrink Platinum+ and PeptiStrong

Other

MediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate

Other names: Clinical Nutrition

Primary outcomes

  1. General well-being via Barthel Index

    Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

    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

Secondary outcomes

  1. Hand Grip Strength via Dynamometer

    Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

    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.

  2. Fat-free body mass via bioelectrical impedance analysis

    Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

    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.

  3. Functional performance via time up & go test

    Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

    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.

Other outcomes

  1. General well-being via Barthel Index (Active control Vs experimental)

    Time frame: Week 2 to Week 12

    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

  2. Hand Grip Strength via Dynamometer ( Active control Vs experimental)

    Time frame: Week 2 to Week 12

    Change in hand grip strength compared from week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong.

  3. Fat-free body mass via bioelectrical impedance analysis

    Time frame: Week 2 to Week 12

    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.

  4. Functional performance via time up & go test (Active control Vs experimental)

    Time frame: Week 2 to Week 12

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Edit Nadasi, MD, PhD

CONTACT

[email protected]

+36 20 251 1762

Sponsors and collaborators

Lead sponsor

Nuritas Ltd

Industry

Collaborators

  • Medifood Hungary Innovation Kft

Registry information

Official study title

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

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Jan 7, 2026
Registry last updated
Jan 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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