Omega 3, Leucine, Probiotic Lactobacillus Paracasei PS23 on Muscle Mass in Sarcopenic Subjects

Azienda di Servizi alla Persona di Pavia

Status: Unknown

Conditions: Omega 3; Elderly; Sarcopenia

Treatments: Dietary Supplement: OLEP; Combination Product: Placebo

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04702087

202000070742

Details and patient eligibility

About

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.

Enrollment: 54 estimated patients

Sex: All

Ages: 55+ years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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54 participants in 2 patient groups, including a placebo group

OLEP

Experimental group

Description:

Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23

Treatment:

Dietary Supplement: OLEP

Placebo

Placebo Comparator group

Description:

isocaloric formula

Treatment:

Combination Product: Placebo