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

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

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.

Study Overview

• Status: Recruiting
• Conditions: Inflammation; Sarcopenia; Gut Permeability
• Intervention / Treatment: Dietary supplement: Miotrof® formula; Dietary supplement: Placebo formula

• Study Type: Interventional
• Enrollment (Anticipated): 60
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Mariangela Rondanelli, MD; Phone Number: 0382381739; Email: mariangela.rondanelli@unipv.it

Study Locations

• Italy
  • Pavia, Italy, 27100
    • Recruiting
    • l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
    • Contact: Mariangela Rondanelli, MD; Phone Number: 0382381739; Email: mariangela.rondanelli@unipv.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intevention group; Experimental formula (Miotrof®) to take 1 sachet per day for 4 months	Dietary supplement: Miotrof® formula; 1 sachet per day for 4 months
Placebo Comparator: Placebo group; Placebo formula to take 1 sachet per day for 4 months	Dietary supplement: Placebo formula; 1 sachet per day for 4 months

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Azienda di Servizi alla Persona di Pavia

Study record dates

Study Major Dates

• Study Start (Actual): October 1, 2022
• Primary Completion (Anticipated): April 30, 2023
• Study Completion (Anticipated): September 30, 2023

Study Registration Dates

• First Submitted: February 7, 2023
• First Submitted That Met QC Criteria: February 15, 2023
• First Posted (Estimate): February 16, 2023

Study Record Updates

• Last Update Posted (Estimate): February 16, 2023
• Last Update Submitted That Met QC Criteria: February 15, 2023
• Last Verified: February 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Neurologic Manifestations; Neuromuscular Manifestations; Pathological Conditions, Anatomical; Muscular Atrophy; Atrophy; Inflammation; Sarcopenia
• Other Study ID Numbers: 1206/01072022

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No