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

Not Applicable

• Conditions: Sarcopenia; Omega 3; Elderly
• Interventions: Combination Product: Placebo; Dietary Supplement: OLEP

• Registration Number: NCT04702087
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2021-01-05
• Study First Submitted QC: 2021-01-07
• Study First Posted: 2021-01-08
• Study Start: 2021-01-22
• Primary Completion: 2021-01-30
• Status Verified: 2021-09
• Last Update Submitted: 2021-09-29
• Last Update Posted: 2021-10-05
• Study Completion: 2022-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 54

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo	Placebo	isocaloric formula
OLEP	OLEP	Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23

Primary Outcome Measures

Name	Time	Method
Changes on muscle mass	Baseline / 30 days / 60 days	Evaluation of fat free mass (g)

Secondary Outcome Measures

Name	Time	Method
Changes on safety parameters	Baseline / 60 days	Evaluation of gamma glutamyl transferase (U/L)
Changes on body composition	Baseline / 30 days / 60 days	Evaluation of fat mass (g) and visceral adipose tissue (g)
Changes on muscle strength	Baseline / 30 days / 60 days	Evaluation of muscle strength (kg)
Changes on functional status	Baseline / 60 days	Evaluation of activities of daily living score (point scale): a simplified scale that provides for the assignment of a point for each independent function in order to obtain a total performance result ranging from 0 (complete dependence) to 6 (independence in all functions).
Changes on mood	Baseline / 60 days	Evaluation of Geriatric Depression Scale (point scale). a 30-question test with yes/no answers. 10 - 15 Points: Probable presence of depression; 6 - 9 Points: Depression possible; 0 - 5 Points: Unlikely Depression.
Changes on plasma free essential amino acids	Baseline / 60 days	Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)
Changes on Quality of life	Baseline / 60 days	Evaluation of Short-Form 12-Item Health Survey (poin survey): a generic health-status measure (physical component summary score and the mental component summary score) by addressing eight health domains (physical functioning, role physical, bodily pain, general health, vitality, social functioning, role emotional, and mental health. Score from 0 (bad quality) to 100 (high quality).
Changes on physical performancy	Baseline / 60 days	Evaluation of Short Physical Performance Battery (point scale) which consists of three components: gait speed, chair-stand test, timed up and go (TUG) test (which assesses the time taken to rise from an arm chair, walk 3 m, turn, walk back, and sit down again), and balance (three different tests assessing ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); accordingly, each component was scored from 0 (not possible) to 4 (best performance) and the scores add up to a total score ranging from 0 to 12.
Changes on blood pressure	Baseline / 60 days	Evaluation of systolic and diastolic pressure (mm/Hg)

Trial Locations

Locations (1)

Azienda di Servizi alla Persona; 🇮🇹 Pavia, Italy