From the Gut to the Strut: Reducing Inflammation for Healthy Muscles

Study Overview
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Brief Summary
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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.

Official Title
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Effectiveness of the Intake of a Food Supplement Based on Hydroxymethylbutyrate, Carnosine, Lactoferrin and Magnesium on Reduction of Inflammation and on the Improvement of the Health of the Muscle

Conditions
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Inflammation, Sarcopenia, Gut Permeability

Intervention / Treatment
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* Dietary Supplement: Miotrof® formula
* Dietary Supplement: Placebo formula


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 55 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intevention group<br>Experimental formula (Miotrof®) to take 1 sachet per day for 4 months | Dietary Supplement: Miotrof® formula<br>* 1 sachet per day for 4 months<br>|
| Placebo Comparator: Placebo group<br>Placebo formula to take 1 sachet per day for 4 months | Dietary Supplement: Placebo formula<br>* 1 sachet per day for 4 months<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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). | 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 |