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

NCT ID: NCT07322653

Last Updated: 2026-01-07

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

75 participants

Study Classification

INTERVENTIONAL

Study Start Date

2025-09-10

Study Completion Date

2027-01-02

Brief Summary

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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

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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

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Sarcopenia in Elderly Malnourished Protein Supplementation Muscle Mass Physical Function Strength

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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MediDrink Platinum+

Base formula containing novel protein blend SPR-01 (Dosed appropriate to nutritional status with a minimum of 1200kcal/day as 600ml)

Group Type ACTIVE_COMPARATOR

MediDrink Platinum+

Intervention Type OTHER

MediDrink Platinum+ containing novel protein blend SPR-01

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

Group Type EXPERIMENTAL

MediDrink Platinum+ and PeptiStrong

Intervention Type OTHER

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

Interventions

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MediDrink Platinum+

MediDrink Platinum+ containing novel protein blend SPR-01

Intervention Type OTHER

MediDrink Platinum+ and PeptiStrong

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

Intervention Type OTHER

Other Intervention Names

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Clinical Nutrition Clinical Nutrition

Eligibility Criteria

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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
Minimum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Medifood Hungary Innovation Kft

UNKNOWN

Sponsor Role collaborator

Nuritas Ltd

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Országos Korányi Pulmonológiai Intézet

Budapest, , Hungary

Site Status RECRUITING

Sóstói Szivárvány Idősek Otthona

Nyíregyháza, , Hungary

Site Status RECRUITING

Countries

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Hungary

Central Contacts

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Edit Nadasi, MD, PhD

Role: CONTACT

+36 20 251 1762

Facility Contacts

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Dr. Gabriella Temesi, Medical Director

Role: primary

+36-1-391-3200

Dr Csaba Kiss, Institutional care physician

Role: primary

+36-70-931-0333

Other Identifiers

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GINOP PLUSZ 2.1.1-21-102200048

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

SPR-K-2024-01

Identifier Type: -

Identifier Source: org_study_id

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