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

Inflammation Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05730985
• Other study ID #: 1206/01072022
• Status: Recruiting
• Phase: N/A
• Start date: October 1, 2022
• Est. completion date: September 30, 2023

Study information

• Verified date: February 2023
• Source: Azienda di Servizi alla Persona di Pavia
• Contact: Mariangela Rondanelli, MD
• Phone: 0382381739
• Email: mariangela.rondanelli[@]unipv.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: September 30, 2023
• Est. primary completion date: April 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 55 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Inflammation
• Sarcopenia

Intervention

Dietary Supplement:
• Miotrof® formula
1 sachet per day for 4 months
• Placebo formula
1 sachet per day for 4 months

Locations

Country	Name	City	State
Italy	l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).	Pavia

Sponsors (1)

Lead Sponsor	Collaborator
Azienda di Servizi alla Persona di Pavia

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	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
Primary	Gut permeability.	A blood sample will be collected and analised for indican	At the beginning of the treatment
Primary	Gut permeability.	A blood sample will be collected and analised for indican	After 4 months of treatment