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Recruiting NCT07322653

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

No phase Interventional Sarcopenia in Elderly Malnourished Protein Supplementation Muscle Mass

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MediDrink Platinum+, MediDrink Platinum+ and PeptiStrong.
Who it may be relevant to
Registry conditions: Sarcopenia in Elderly, Malnourished, Protein Supplementation, Muscle Mass. Basic parameters: from 60 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Hungary
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Official 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

Overview

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

Detailed description

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.

Interventions

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

Primary outcome measures

  • General well-being via Barthel Index [Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12]
Secondary outcome measures (3)
  • Hand Grip Strength via Dynamometer [Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12]
  • Fat-free body mass via bioelectrical impedance analysis [Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12]
  • Functional performance via time up & go test [Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12]

Eligibility 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

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Supportive care

Study locations

Hungary · 2 centers
  • Országos Korányi Pulmonológiai Intézet — Budapest
  • Sóstói Szivárvány Idősek Otthona — Nyíregyháza

Identifiers

NCT: NCT07322653 · SPR-K-2024-01 · GINOP PLUSZ 2.1.1-21-102200048

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗