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

December 22, 2025 updated by: Nuritas Ltd

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

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

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Estimated)

75

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Hungary
      • Budapest, Hungary, 1121
        • Recruiting
        • Országos Korányi Pulmonológiai Intézet
        • Contact:
          • Dr. Gabriella Temesi, Medical Director
          • Phone Number: +36-1-391-3200
          • Email: temesi@koranyi.hu
      • Nyíregyháza, Hungary, 4431
        • Recruiting
        • Sóstói Szivárvány Idősek Otthona
        • Contact:
          • Dr Csaba Kiss, Institutional care physician
          • Phone Number: +36-70-931-0333
          • Email: koremed@gmail.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: MediDrink Platinum+
Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml)
Other: MediDrink Platinum+
MediDrink Platinum+ containing novel protein blend SPR-01
Other Names:
  • Clinical Nutrition
Experimental: MediDrink Platinum+ and PeptiStrong
Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml) and 2.4g/day PeptiStrong
Other: MediDrink Platinum+ and PeptiStrong
MediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate
Other Names:
  • Clinical Nutrition

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
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
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.
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
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.
Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
Week 2 to Week 12
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.
Week 2 to Week 12
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.
Week 2 to Week 12
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.
Week 2 to Week 12

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nuritas Ltd

Collaborators

Medifood Hungary Innovation Kft

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

September 10, 2025

Primary Completion (Estimated)

October 1, 2026

Study Completion (Estimated)

January 2, 2027

Study Registration Dates

First Submitted

December 22, 2025

First Submitted That Met QC Criteria

December 22, 2025

First Posted (Actual)

January 7, 2026

Study Record Updates

Last Update Posted (Actual)

January 7, 2026

Last Update Submitted That Met QC Criteria

December 22, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SPR-K-2024-01
  • GINOP PLUSZ 2.1.1-21-102200048 (Other Grant/Funding Number: GINOP PLUSZ)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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