Elderly, Omega 3, Sarcopenia
Conditions
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.
Interventions
DIETARY_SUPPLEMENTOLEP
omega 3 (500 mg), leucine (2,5 g), probiotic Lactobacillus paracasei PS23
COMBINATION_PRODUCTPlacebo
Isocaloric formula
Sponsors
Abiogen Pharma
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
55 Years to No maximum
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Changes on muscle mass | Baseline / 30 days / 60 days | Evaluation of fat free mass (g) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Changes on physical performancy | Baseline / 60 days | 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) |
| Changes on functional status | Baseline / 60 days | 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)) |
| Changes on muscle strength | Baseline / 30 days / 60 days | Evaluation of muscle strength (kg) |
| 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 body composition | Baseline / 30 days / 60 days | Evaluation of fat mass (g) and visceral adipose tissue (g) |
| Changes on blood pressure | Baseline / 60 days | Evaluation of systolic and diastolic pressure (mm/Hg) |
| 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 safety parameters | Baseline / 60 days | Evaluation of creatinine (mg/dl) |
| 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. |
Countries
Italy
Contacts
Primary ContactMariangela Rondanelli
Outcome results
None listed