Sarcopenia in ElderlyNCT07322653
The Effects of MediDrink Platinum+ and Fava Bean Protein Hydrolysate on Fitness in an Aged Population
A study testing MediDrink Platinum+ and MediDrink Platinum+ and PeptiStrong in people with Sarcopenia in Elderly and Malnourished, run by Nuritas Ltd at 2 sites in Hungary.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 60 years and older
- Conditions the study is for
- Sarcopenia in Elderly, Malnourished, Protein Supplementation
- What is being tested?
- MediDrink Platinum+ and MediDrink Platinum+ and PeptiStrong
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 2 sitesHungary
- Study dates
- 10 Sep 2025to 2 Jan 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 11Show fewer
- 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
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Hungary2 sites, 2 recruiting
- Recruiting
Országos Korányi Pulmonológiai Intézet
Budapest, 1121
Dr. Gabriella Temesi, Medical Director, +36-1-391-3200, temesi@koranyi.hu
- Recruiting
Sóstói Szivárvány Idősek Otthona
Nyíregyháza, 4431
Dr Csaba Kiss, Institutional care physician, +36-70-931-0333, koremed@gmail.com
About this study
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
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
Read the 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.
- Conditions
- Sarcopenia in Elderly, Malnourished, Protein Supplementation, Muscle Mass, Physical Function, Strength
- Being tested
- MediDrink Platinum+, MediDrink Platinum+ and PeptiStrong
- Keywords
- Sarcopenia, Peptide Therapeutics, PeptiStrong, MediDrink Platinum, Malnourished Elderly, Physical functioning, MediDrink Platinum+, Clinical Nurtition, Nutritional status
- Medical subject headings
- Malnutrition, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MediDrink Platinum+Other
Also called Clinical Nutrition
MediDrink Platinum+ containing novel protein blend SPR-01
MediDrink Platinum+ and PeptiStrongOther
Also called Clinical Nutrition
MediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate
| Study group | Role | What they receive |
|---|---|---|
| MediDrink Platinum+ | Active comparator | Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml) Receives: Other: MediDrink Platinum+ |
| MediDrink Platinum+ and PeptiStrong | Experimental | 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 Receives: Other: MediDrink Platinum+ and PeptiStrong |
What is being measured
The primary outcome is the main question the study is designed to answer.
General well-being via Barthel Index
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
Measured: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Secondary outcomes (3)
Hand Grip Strength via Dynamometer
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.
Measured: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Fat-free body mass via bioelectrical impedance analysis
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.
Measured: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Functional performance via time up & go test
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.
Measured: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2026
- Study start10 Sep 2025
- Primary completion1 Oct 2026 (estimated)
- Study completion2 Jan 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Sarcopenia in ElderlyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- All participants begin on the base formula MediDrink Platinum before splitting into one of two arms, the version containing novel protein blend SPR-01, MediDrink Platinum+, or MediDrink Platinum+ and 2.4g of PeptiStrong supplement
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 75 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Nuritas Ltd
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Medifood Hungary Innovation Kft
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07322653
- Sponsor's protocol ID
- SPR-K-2024-01
- Other IDs
- GINOP PLUSZ 2.1.1-21-102200048
- Status last verified
- Dec 2025
- First submitted
- 22 Dec 2025
- Last updated
- 7 Jan 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Jan 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07322653
- Acronym / sponsor ID
- SPR-K-2024-01
- Conditions
- Sarcopenia in Elderly, Malnourished, Protein Supplementation, Muscle Mass, Physical Function, Strength
- Keywords
- Sarcopenia, Peptide Therapeutics, PeptiStrong, MediDrink Platinum, Malnourished Elderly, Physical functioning, MediDrink Platinum+, Clinical Nurtition
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 75 participants (estimated)
- Lead sponsor
- Nuritas LtdIndustry (pharma, biotech, devices)
- Collaborators
- Medifood Hungary Innovation Kft
- Study start
- 10 Sep 2025 (actual)
- Primary completion
- 1 Oct 2026 (estimated)
- Study completion
- 2 Jan 2027 (estimated)
- First posted
- 7 Jan 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
- Model description
- All participants begin on the base formula MediDrink Platinum before splitting into one of two arms, the version containing novel protein blend SPR-01, MediDrink Platinum+, or MediDrink Platinum+ and 2.4g of PeptiStrong supplement
| Arm | Type | Receives |
|---|---|---|
| MediDrink Platinum+ | Active comparator | Other: MediDrink Platinum+Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml) |
| MediDrink Platinum+ and PeptiStrong | Experimental | Other: MediDrink Platinum+ and PeptiStrongBase 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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
Key exclusion criteria (11 listed)
- Patient cannot eat orally
- Acute Infection
- Proven Intestinal obstruction
- Co-morbidities requiring a special diet (diabetes, kidney disease etc.)
- Liver dysfunction
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MediDrink Platinum+Also: Clinical NutritionMediDrink Platinum+ containing novel protein blend SPR-01 | Other | MediDrink Platinum+ |
| MediDrink Platinum+ and PeptiStrongAlso: Clinical NutritionMediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate | Other | MediDrink Platinum+ and PeptiStrong |
Primary outcome
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
3 secondary outcomes
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Jan 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MediDrink Platinum+ and MediDrink Platinum+ and PeptiStrong in people with Sarcopenia in Elderly and Malnourished, run by Nuritas Ltd at 2 sites in Hungary.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 7 Jan 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Hungary. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Edit Nadasi, MD, PhD (+36 20 251 1762, clinicaltrials@medifoodinternational.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
General well-being via Barthel Index (time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Jan 2026.