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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

54 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-01-22

Study Completion Date

2022-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Sarcopenia Elderly Omega 3

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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OLEP

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

Group Type EXPERIMENTAL

OLEP

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

isocaloric formula

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type COMBINATION_PRODUCT

Isocaloric formula

Interventions

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OLEP

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

Isocaloric formula

Intervention Type COMBINATION_PRODUCT

Eligibility Criteria

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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

Minimum Eligible Age

55 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes