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

NCT07322653 | Recruiting

• 2 other identifiers: SPR-K-2024-01GINOP PLUSZ 2.1.1-21-102200048
• Study Type: interventional
• Target: 75
• Locations: 1 country
• Sites: 2

Brief 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

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; Nutritional status

Outcome Measures

Primary Outcomes (1)

• 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

  Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Secondary Outcomes (3)

• Hand Grip Strength via Dynamometer

  Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

• Fat-free body mass via bioelectrical impedance analysis

  Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

• Functional performance via time up & go test

  Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Other Outcomes (4)

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

  Week 2 to Week 12

• Hand Grip Strength via Dynamometer ( Active control Vs experimental)

  Week 2 to Week 12

• Fat-free body mass via bioelectrical impedance analysis

  Week 2 to Week 12

Study Arms (2)

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)

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

Other: MediDrink Platinum+ and PeptiStrong

Interventions

MediDrink Platinum+ OTHER

MediDrink Platinum+ containing novel protein blend SPR-01

Also known as: Clinical Nutrition

MediDrink Platinum+

MediDrink Platinum+ and PeptiStrong OTHER

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

Also known as: Clinical Nutrition

MediDrink Platinum+ and PeptiStrong

Eligibility Criteria

• Age: 60 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Nuritas Ltd: lead
• Medifood Hungary Innovation Kft: collaborator

Study Sites (2)

Országos Korányi Pulmonológiai Intézet

Budapest, 1121, Hungary

RECRUITING

Sóstói Szivárvány Idősek Otthona

Nyíregyháza, 4431, Hungary

RECRUITING

MeSH Terms

Conditions

Malnutrition; Sarcopenia

Condition Hierarchy (Ancestors)

Nutrition Disorders; Nutritional and Metabolic Diseases; Muscular Atrophy; Neuromuscular Manifestations; Neurologic Manifestations; Nervous System Diseases; Atrophy; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms; Signs and Symptoms

Central Study Contacts

Edit Nadasi, MD, PhD

CONTACT

+36 20 251 1762; clinicaltrials@medifoodinternational.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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

Study Record Dates

• First Submitted: December 22, 2025
• First Posted: January 7, 2026
• Study Start: September 10, 2025
• Primary Completion (Estimated): October 1, 2026
• Study Completion (Estimated): January 2, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will not share

Locations

HU (2)