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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

60 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-10-01

Study Completion Date

2023-09-30

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.

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Detailed Description

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Conditions

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Inflammation Sarcopenia Gut Permeability

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Intevention group

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

Group Type EXPERIMENTAL

Miotrof® formula

Intervention Type DIETARY_SUPPLEMENT

1 sachet per day for 4 months

Placebo group

Placebo formula to take 1 sachet per day for 4 months

Group Type PLACEBO_COMPARATOR

Placebo formula

Intervention Type DIETARY_SUPPLEMENT

1 sachet per day for 4 months

Interventions

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Miotrof® formula

1 sachet per day for 4 months

Intervention Type DIETARY_SUPPLEMENT

Placebo formula

1 sachet per day for 4 months

Intervention Type DIETARY_SUPPLEMENT

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

Minimum Eligible Age

55 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No