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

Sarcopenia Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04702087
• Other study ID #: 202000070742
• Status: Recruiting
• Phase: N/A
• Start date: January 22, 2021
• Est. completion date: December 2022

Study information

• Verified date: September 2021
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: Mariangela Rondanelli
• Phone: +390382381749
• Email: mariangela.rondanelli[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 54
• Est. completion date: December 2022
• Est. primary completion date: January 30, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Elderly
• Omega 3
• Sarcopenia

Intervention

Dietary Supplement:
• OLEP
omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23

Combination Product:
• Placebo
Isocaloric formula

Locations

Country	Name	City	State
Italy	Azienda di Servizi alla Persona	Pavia

Sponsors (2)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia	Abiogen Pharma

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes on muscle mass	Evaluation of fat free mass (g)	Baseline / 30 days / 60 days
Secondary	Changes on body composition	Evaluation of fat mass (g) and visceral adipose tissue (g)	Baseline / 30 days / 60 days
Secondary	Changes on physical performancy	Evaluation of Tinetti scale (point scale) that measures characteristics associated with falls, assessing balance (14 items; 24 points), and gait (10 items; 16 points) for a total score up to 40 (the higher the score, the better the performance)	Baseline / 60 days
Secondary	Changes on physical performancy	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.	Baseline / 60 days
Secondary	Changes on functional status	Evaluation of Barthel Index (point scale) (covering all the aspects of self-care independence in daily living activities, including transfer, walking, stairs, toilet use, dressing, feeding, bladder, bowel, grooming, and bathing; score range, 0 (completely dependent) -100 (complete self-sufficiency))	Baseline / 60 days
Secondary	Changes on functional status	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).	Baseline / 60 days
Secondary	Changes on muscle strength	Evaluation of muscle strength (kg)	Baseline / 30 days / 60 days
Secondary	Changes on Quality of life	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).	Baseline / 60 days
Secondary	Changes on mood	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.	Baseline / 60 days
Secondary	Changes on blood pressure	Evaluation of systolic and diastolic pressure (mm/Hg)	Baseline / 60 days
Secondary	Changes on plasma free essential amino acids	Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)	Baseline / 60 days
Secondary	Changes on safety parameters	Evaluation of creatinine (mg/dl)	Baseline / 60 days
Secondary	Changes on safety parameters	Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L)	Baseline / 60 days
Secondary	Changes on safety parameters	Evaluation of gamma glutamyl transferase (U/L)	Baseline / 60 days