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

Study Overview
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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.

Official Title
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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

Conditions
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Sarcopenia, Elderly, Omega 3

Intervention / Treatment
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* Dietary Supplement: OLEP
* Combination Product: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: OLEP<br>Omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23 | Dietary Supplement: OLEP<br>* omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23<br>|
| Placebo Comparator: Placebo<br>isocaloric formula | Combination Product: Placebo<br>* Isocaloric formula<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on muscle mass | Evaluation of fat free mass (g) | Baseline / 30 days / 60 days | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes on body composition | Evaluation of fat mass (g) and visceral adipose tissue (g) | Baseline / 30 days / 60 days | 
| 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 | 
| 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 | 
| 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 | 
| 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 | 
| Changes on muscle strength | Evaluation of muscle strength (kg) | Baseline / 30 days / 60 days | 
| 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 | 
| 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 | 
| Changes on blood pressure | Evaluation of systolic and diastolic pressure (mm/Hg) | Baseline / 60 days | 
| Changes on plasma free essential amino acids | Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L) | Baseline / 60 days | 
| Changes on safety parameters | Evaluation of creatinine (mg/dl) | Baseline / 60 days | 
| Changes on safety parameters | Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L) | Baseline / 60 days | 
| Changes on safety parameters | Evaluation of gamma glutamyl transferase (U/L) | Baseline / 60 days |