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

Not Applicable

Recruiting

• Conditions: Sarcopenia; Gut Permeability; Inflammation
• Interventions: Dietary Supplement: Miotrof® formula; Dietary Supplement: Placebo formula

• Registration Number: NCT05730985
• Lead Sponsor: Azienda di Servizi alla Persona di Pavia

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2022-10-01
• Status Verified: 2023-02
• Study First Submitted: 2023-02-07
• Study First Submitted QC: 2023-02-15
• Last Update Submitted: 2023-02-15
• Study First Posted: 2023-02-16
• Last Update Posted: 2023-02-16
• Primary Completion: 2023-04-30
• Study Completion: 2023-09-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 60

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Intevention group	Miotrof® formula	Experimental formula (Miotrof®) to take 1 sachet per day for 4 months
Placebo group	Placebo formula	Placebo formula to take 1 sachet per day for 4 months

Primary Outcome Measures

Name	Time	Method
Muscle strength evaluation	After 4 months of 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
Inflammation status	After 4 months of treatment	A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
body composition assessment	After 4 months of treatment	Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).
Gut permeability.	After 4 months of treatment	A blood sample will be collected and analised for indican
Physical performance assessment	After 4 months of 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.

Trial Locations

Locations (1)

l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).; 🇮🇹 Pavia, Italy