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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04702087
Other study ID # 202000070742
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
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