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
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.
Eligibility
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