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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
54
Azienda di Servizi alla Persona
Pavia, Italy
RECRUITINGChanges on muscle mass
Evaluation of fat free mass (g)
Time frame: Baseline / 30 days / 60 days
Changes on body composition
Evaluation of fat mass (g) and visceral adipose tissue (g)
Time frame: 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)
Time frame: 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.
Time frame: 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))
Time frame: 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).
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Time frame: Baseline / 60 days
Changes on muscle strength
Evaluation of muscle strength (kg)
Time frame: 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).
Time frame: 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.
Time frame: Baseline / 60 days
Changes on blood pressure
Evaluation of systolic and diastolic pressure (mm/Hg)
Time frame: Baseline / 60 days
Changes on plasma free essential amino acids
Evaluation of free essential amino acids in plasma (Leucine, Isoleucine, Valine) (micromol/L)
Time frame: Baseline / 60 days
Changes on safety parameters
Evaluation of creatinine (mg/dl)
Time frame: Baseline / 60 days
Changes on safety parameters
Evaluation of alanine aminotransferase and aspartate aminotransferase (IU/L)
Time frame: Baseline / 60 days
Changes on safety parameters
Evaluation of gamma glutamyl transferase (U/L)
Time frame: Baseline / 60 days