NCT04702087
Unknown
N/A
Randomized, Placebo-controlled Clinical Study to Evaluate the Effect of 2 Months of Nutritional Support Based on Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 (OLEP Study) on Muscle Mass in Sarcopenic Subjects
Azienda di Servizi alla Persona di Pavia1 site in 1 country54 target enrollmentJanuary 22, 2021
Overview
- Phase
- N/A
- Intervention
- Not specified
- Conditions
- Sarcopenia
- Sponsor
- Azienda di Servizi alla Persona di Pavia
- Enrollment
- 54
- Locations
- 1
- Primary Endpoint
- Changes on muscle mass
- Last Updated
- 4 years ago
Overview
Brief Summary
The purpose of the study is to evaluate the effect of supplementation with a nutritional blend based on Omega 3 fatty acids, the probiotic leucine Lactobacillus paracasei PS23 (OLEP), on muscle mass recovery in sarcopenic patients.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Sarcopenic patients (diagnosis made according to the criteria Revised European Consensus on Definition and Diagnosis)
- •Body Mass Index between 20 and 30 Kg/m2
Exclusion Criteria
- •severe renal failure (glomerular filtration rate \< 30 mL/min)
- •moderate to severe liver failure (Child-Pugh class B or C)
- •endocrine diseases associated with calcium metabolism disorders (except osteoporosis)
- •known psychiatric disorders
- •cancer (over the past 5 years)
- •hypersensitivity to any component of the investigational nutritional supplement and
- •taking to protein/amino acid supplements (up to 3 months before starting the study)
- •patients unable to take oral therapy
- •receiving or with indication for artificial nutrition
- •who had been included in another clinical nutrition trial
Outcomes
Primary Outcomes
Changes on muscle mass
Time Frame: Baseline / 30 days / 60 days
Evaluation of fat free mass (g)
Secondary Outcomes
- Changes on body composition(Baseline / 30 days / 60 days)
- Changes on muscle strength(Baseline / 30 days / 60 days)
- Changes on functional status(Baseline / 60 days)
- Changes on mood(Baseline / 60 days)
- Changes on plasma free essential amino acids(Baseline / 60 days)
- Changes on safety parameters(Baseline / 60 days)
- Changes on Quality of life(Baseline / 60 days)
- Changes on physical performancy(Baseline / 60 days)
- Changes on blood pressure(Baseline / 60 days)
Study Sites (1)
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