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

Azienda di Servizi alla Persona di Pavia

Status: Enrolling

Conditions: Inflammation; Gut Permeability; Sarcopenia

Treatments: Dietary Supplement: Miotrof® formula; Dietary Supplement: Placebo formula

Study type: Interventional

Funder types: Other

Identifiers

NCT05730985

1206/01072022

Details and patient eligibility

About

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.

Enrollment: 60 estimated patients

Sex: All

Ages: 55 to 85 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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60 participants in 2 patient groups, including a placebo group

Intevention group

Experimental group

Description:

Experimental formula (Miotrof®) to take 1 sachet per day for 4 months

Treatment:

Dietary Supplement: Miotrof® formula

Placebo group

Placebo Comparator group

Description:

Placebo formula to take 1 sachet per day for 4 months

Treatment:

Dietary Supplement: Placebo formula