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

Nuritas Ltd75 enrolled

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

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

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

DOUBLE

Enrollment

Conditions

Sarcopenia in Elderly Malnourished Protein Supplementation Muscle Mass Physical Function Strength

Interventions

MediDrink Platinum+OTHER

MediDrink Platinum+ containing novel protein blend SPR-01

MediDrink Platinum+ and PeptiStrongOTHER

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

Eligibility

Sex: ALLMin age: 60 Years

Medical Language ↔ Plain English

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

Locations (2)

Országos Korányi Pulmonológiai Intézet

Budapest, Hungary

RECRUITING

Sóstói Szivárvány Idősek Otthona

Nyíregyháza, Hungary

RECRUITING

Outcomes

Primary Outcomes

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

Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Secondary Outcomes

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.

Time frame: 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.

Time frame: 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.

Time frame: Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12

Central Contacts

Edit Nadasi, MD, PhD

CONTACT

+36 20 251 1762 clinicaltrials@medifoodinternational.com

Data from ClinicalTrials.gov

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