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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intevention group | Experimental | Experimental formula (Miotrof®) to take 1 sachet per day for 4 months |
|
| Placebo group | Placebo Comparator | Placebo formula to take 1 sachet per day for 4 months |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Miotrof® formula | Dietary Supplement | 1 sachet per day for 4 months |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Inflammation status | A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa) | At the beginning of the treatment |
| Inflammation status | A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa) | After 4 months of treatment |
| Muscle strength evaluation | 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 | At the beginning of the treatment |
| Muscle strength evaluation | 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 | After 4 months of treatment |
| body composition assessment | Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA). | At the beginning of the treatment |
| body composition assessment | Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mariangela Rondanelli, MD | Contact | 0382381739 | mariangela.rondanelli@unipv.it |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP). | Recruiting | Pavia | 27100 | Italy |
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| ID | Term |
|---|---|
| D007249 | Inflammation |
| D055948 | Sarcopenia |
| ID | Term |
|---|---|
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009133 | Muscular Atrophy |
| D020879 | Neuromuscular Manifestations |
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| Placebo formula |
| Dietary Supplement |
1 sachet per day for 4 months |
|
| After 4 months of treatment |
| Physical performance assessment | 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. | At the beginning of the treatment |
| Physical performance assessment | 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. | After 4 months of treatment |
| Gut permeability. | A blood sample will be collected and analised for indican | At the beginning of the treatment |
| Gut permeability. | A blood sample will be collected and analised for indican | After 4 months of treatment |
| D009461 | Neurologic Manifestations |
| D009422 | Nervous System Diseases |
| D001284 | Atrophy |
| D020763 | Pathological Conditions, Anatomical |
| D012816 | Signs and Symptoms |