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

Nuritas

Status: Enrolling

Conditions: Physical Function; Muscle Mass; Strength; Malnourished; Sarcopenia in Elderly; Protein Supplementation

Treatments: Other: MediDrink Platinum+; Other: MediDrink Platinum+ and PeptiStrong

Study type: Interventional

Funder types: Industry; Other

Identifiers

NCT07322653

SPR-K-2024-01

GINOP PLUSZ 2.1.1-21-102200048 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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.

Enrollment: 75 estimated patients

Sex: All

Ages: 60+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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75 participants in 2 patient groups

MediDrink Platinum+

Active Comparator group

Description:

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

Treatment:

Other: MediDrink Platinum+

MediDrink Platinum+ and PeptiStrong

Experimental group

Description:

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

Treatment:

Other: MediDrink Platinum+ and PeptiStrong