Inflammation, Sarcopenia, Gut Permeability
Conditions
Brief summary
This research aims to evaluate the effectiveness of a dietary supplement on reducing inflammation and improving muscle health. The product is a food supplement notified to the Ministry of Health consisting of: hydroxymethylbutyrate, carnosine, lactoferrin and magnesium, which help reduce inflammation and intestinal permeability and to improve muscle health.
Interventions
DIETARY_SUPPLEMENTMiotrof® formula
1 sachet per day for 4 months
DIETARY_SUPPLEMENTPlacebo formula
1 sachet per day for 4 months
Sponsors
Azienda di Servizi alla Persona di Pavia
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)
Eligibility
Sex/Gender
ALL
Age
55 Years to 85 Years
Healthy volunteers
No
Inclusion criteria
* sarcopenic patients aged 55-85. Sarcopenia will be diagnosed according to the European Working Group on Sarcopenia in Older People (EWSGOP-2) criteria by muscle strength or chair stand test.
Exclusion criteria
* severe kidney disease (glomerular filtration rate \<30 mL/min), * moderate-to-severe hepatic failure (Child-Pugh Class of B or C), * endocrine diseases associated with disorders of calcium metabolism (with the exception of osteoporosis), * psychiatric disorders, * cancer (in the previous 5 years), * hypersensitivity to any investigational food component * subjects taking protein/amino acid supplements (up to 3 months prior to the study). * patients not capable of taking oral therapy and those receiving or having indication for artificial nutrition or included in another clinical nutrition trial
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Inflammation status | At the beginning of the treatment | A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa) |
| Muscle strength evaluation | At the beginning of the treatment | Muscle strength was measured by handgrip strength according to standard procedures by a hydraulic hand dynamometer (Jamar 5030 J1, Sammons Preston Rolyan, Bolingbrook, Canada with an accuracy of 0.6 N). The subject holds the dy-namometer in the hand to be tested, with the arm at right angles and the elbow by the side of the body, applying an isometric contraction |
| body composition assessment | At the beginning of the treatment | Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA). |
| Physical performance assessment | At the beginning of the treatment | Physical performance was assessed using the Short Physical Performance battery test (SPPB) which comprised of gait speed, chair-stand test, and balance (three different tests that assess the ability to stand with the feet together in the side-by-side, semi-tandem, and tandem positions); each component was scored from 0 (not possible) to 4 (best performance) and the scores were added up to a total score ranging from 0 to 12. |
| Gut permeability. | At the beginning of the treatment | A blood sample will be collected and analised for indican |
Countries
Italy
Contacts
Primary ContactMariangela Rondanelli, MD
Outcome results
None listed