InflammationNCT05730985
From the Gut to the Strut: Reducing Inflammation for Healthy Muscles
A study testing Miotrof® formula in people with Inflammation and Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 55 to 85 years
- Conditions the study is for
- Inflammation, Sarcopenia, Gut Permeability
- What is being tested?
- Miotrof® formula
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteItaly
- Study dates
- 1 Oct 2022to 30 Sep 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 55 to 85 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
Pavia, 27100
Mariangela Rondanelli, MD, 0382381739, mariangela.rondanelli@unipv.it
About this study
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
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.
- Conditions
- Inflammation, Sarcopenia, Gut Permeability
- Being tested
- Miotrof® formula, Placebo formula
- Medical subject headings
- Inflammation, Sarcopenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miotrof® formulaDietary supplement
1 sachet per day for 4 months
Placebo formulaDietary supplement
1 sachet per day for 4 months
| Study group | Role | What they receive |
|---|---|---|
| Intevention group | Experimental | Experimental formula (Miotrof®) to take 1 sachet per day for 4 months Receives: Dietary Supplement: Miotrof® formula |
| Placebo group | Placebo comparator | Placebo formula to take 1 sachet per day for 4 months Receives: Dietary Supplement: Placebo formula |
What is being measured
The primary outcome is the main question the study is designed to answer.
Inflammation status
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Measured: 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)
Measured: 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
Measured: 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
Measured: 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).
Measured: 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).
Measured: 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.
Measured: 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.
Measured: After 4 months of treatment
Gut permeability.
A blood sample will be collected and analised for indican
Measured: At the beginning of the treatment
Gut permeability.
A blood sample will be collected and analised for indican
Measured: After 4 months of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2023
- Study start1 Oct 2022
- Primary completion30 Apr 2023 (estimated)
- Study completion30 Sep 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda di Servizi alla Persona di Pavia
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05730985
- Sponsor's protocol ID
- 1206/01072022
- Status last verified
- Feb 2023
- First submitted
- 7 Feb 2023
- Last updated
- 16 Feb 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Feb 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05730985
- Acronym / sponsor ID
- 1206/01072022
- Conditions
- Inflammation, Sarcopenia, Gut Permeability
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Azienda di Servizi alla Persona di PaviaUniversity, hospital or other
- Study start
- 1 Oct 2022 (actual)
- Primary completion
- 30 Apr 2023 (estimated)
- Study completion
- 30 Sep 2023 (estimated)
- First posted
- 16 Feb 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intevention group | Experimental | Dietary Supplement: Miotrof® formulaExperimental formula (Miotrof®) to take 1 sachet per day for 4 months |
| Placebo group | Placebo comparator | Dietary Supplement: Placebo formulaPlacebo formula to take 1 sachet per day for 4 months |
Who may qualify
- Ages
- 55 to 85 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- 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.
Key exclusion criteria (8 listed)
- 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),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Miotrof® formula1 sachet per day for 4 months | Dietary supplement | Intevention group |
| Placebo formula1 sachet per day for 4 months | Dietary supplement | Placebo group |
Primary outcome
Inflammation status
Time frame: At the beginning of the treatment
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Inflammation status
Time frame: After 4 months of treatment
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Muscle strength evaluation
Time frame: At the beginning of the 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
Muscle strength evaluation
Time frame: 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
body composition assessment
Time frame: At the beginning of the treatment
Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).
body composition assessment
Time frame: 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).
Physical performance assessment
Time frame: At the beginning of the 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.
Physical performance assessment
Time frame: 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.
Gut permeability.
Time frame: At the beginning of the treatment
A blood sample will be collected and analised for indican
Gut permeability.
Time frame: After 4 months of treatment
A blood sample will be collected and analised for indican
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Feb 2023.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miotrof® formula in people with Inflammation and Sarcopenia, run by Azienda di Servizi alla Persona di Pavia at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Mariangela Rondanelli, MD (0382381739, mariangela.rondanelli@unipv.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Inflammation status (time frame: At the beginning of the treatment). The study lists 10 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.