Malnourished, Muscle Mass, Physical Function, Protein Supplementation, Sarcopenia in Elderly, Strength
Conditions
Keywords
Sarcopenia, Peptide Therapeutics, PeptiStrong, MediDrink Platinum, Malnourished Elderly, Physical functioning, MediDrink Platinum+, Clinical Nurtition, Nutritional status
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
Detailed 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.
Interventions
OTHERMediDrink Platinum+
MediDrink Platinum+ containing novel protein blend SPR-01
OTHERMediDrink Platinum+ and PeptiStrong
MediDrink Platinum+ containing novel protein blend SPR-01 and PeptiStrong, fava bean protein hydrolysate
Sponsors
Medifood Hungary Innovation Kft
Nuritas Ltd
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
DOUBLE (Subject, Outcomes Assessor)
Intervention model description
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
Eligibility
Sex/Gender
ALL
Age
60 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| General well-being via Barthel Index | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Hand Grip Strength via Dynamometer | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 | 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. |
| Fat-free body mass via bioelectrical impedance analysis | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 | 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. |
| Functional performance via time up & go test | Whole group Week 0 to Week 2. Investigational arms Week 2 to Week 12 | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Functional performance via time up & go test (Active control Vs experimental) | Week 2 to Week 12 | Change in time to up & go compared from week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. |
| General well-being via Barthel Index (Active control Vs experimental) | Week 2 to Week 12 | Time to 5 point change in Barthel Index compared from 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 |
| Hand Grip Strength via Dynamometer ( Active control Vs experimental) | Week 2 to Week 12 | Change in hand grip strength compared from week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. |
| Fat-free body mass via bioelectrical impedance analysis | Week 2 to Week 12 | Change in Fat-free body mass compared from week 2 to week 12 in the two study groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong. |
Countries
Hungary
Contacts
Primary ContactEdit Nadasi, MD, PhD
Outcome results
None listed