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

Last updated: September 29, 2021
Sponsor: Azienda di Servizi alla Persona di Pavia
Overall Status: Active - Recruiting

Phase

N/A

Condition

Sarcopenia

Aging

Treatment

N/A

Clinical Study ID

NCT04702087
202000070742
  • Ages > 55
  • All Genders
  • Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Sarcopenic patients (diagnosis made according to the criteria Revised EuropeanConsensus on Definition and Diagnosis)
  • Body Mass Index between 20 and 30 Kg/m2

Exclusion

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

Study Design

Total Participants: 54
Study Start date:
January 22, 2021
Estimated Completion Date:
December 31, 2022

Connect with a study center

  • Azienda di Servizi alla Persona

    Pavia, 27100
    Italy

    Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.