Health TrialsbyHealthPanel

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

ConditionsSarcopenia in ElderlyMalnourishedProtein SupplementationMuscle MassPhysical FunctionStrength
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age60+
SponsorNuritas Ltd

About this trial

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

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

60 years or older

BMI ≤ 25 kg/m²

Malnourished (mini nutritional assessment MNA <11

Sarcopenic: SARC-F score ≥ 4

Disqualifiers

Patient cannot eat orally

Acute Infection

Proven Intestinal obstruction

Co-morbidities requiring a special diet (diabetes, kidney disease etc.)

Trial design

Design model

Parallel

Treatments tested in this trial

  • MediDrink Platinum+

    Other intervention

    MediDrink Platinum+ containing novel protein blend SPR-01

  • MediDrink Platinum+ and PeptiStrong

    Other intervention

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

Treatment groups

75 Participants
are divided into 2 treatment groups
Group A: MediDrink Platinum+Active comparator 1 intervention
Group B: MediDrink Platinum+ and PeptiStrongExperimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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

1

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
2

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
3

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

Other outcomes

1

General well-being via Barthel Index (Active control Vs experimental)

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

Time frame
Week 2 to Week 12
2

Hand Grip Strength via Dynamometer ( Active control Vs experimental)

Change in hand grip strength compared from week 2 to week 12 in the two investigational groups; MediDrink Platinum+ and MediDrink Platinum+ with PeptiStrong.

Time frame
Week 2 to Week 12
3

Fat-free body mass via bioelectrical impedance analysis

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.

Time frame
Week 2 to Week 12
4

Functional performance via time up & go test (Active control Vs experimental)

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.

Time frame
Week 2 to Week 12

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Nuritas Ltd

Lead sponsor

Medifood Hungary Innovation Kft

Collaborator

Source ClinicalTrials.gov
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