Back to resultsFrom the Gut to the Strut: Reducing Inflammation for Healthy Muscles
Primary Purpose
Inflammation, Sarcopenia, Gut Permeability
Status
Recruiting
Phase
Not Applicable
Locations
Italy
Study Type
Interventional
Intervention
Miotrof® formula
Placebo formula
Sponsored by
About this trial
This is an interventional treatment trial for Inflammation
Eligibility Criteria
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
Sites / Locations
- l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).Recruiting
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Intevention group
Placebo group
Arm Description
Experimental formula (Miotrof®) to take 1 sachet per day for 4 months
Placebo formula to take 1 sachet per day for 4 months
Outcomes
Primary Outcome Measures
Inflammation status
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Inflammation status
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
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
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
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).
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).
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.
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.
Gut permeability.
A blood sample will be collected and analised for indican
Gut permeability.
A blood sample will be collected and analised for indican
Secondary Outcome Measures
Full Information
NCT ID
NCT05730985
First Posted
February 7, 2023
Last Updated
February 15, 2023
Sponsor
Azienda di Servizi alla Persona di Pavia
1. Study Identification
Unique Protocol Identification Number
NCT05730985
Brief Title
From the Gut to the Strut: Reducing Inflammation for Healthy Muscles
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
April 30, 2023 (Anticipated)
Study Completion Date
September 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Azienda di Servizi alla Persona di Pavia
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Inflammation, Sarcopenia, Gut Permeability
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
60 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Intevention group
Arm Type
Experimental
Arm Description
Experimental formula (Miotrof®) to take 1 sachet per day for 4 months
Arm Title
Placebo group
Arm Type
Placebo Comparator
Arm Description
Placebo formula to take 1 sachet per day for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Miotrof® formula
Intervention Description
1 sachet per day for 4 months
Intervention Type
Dietary Supplement
Intervention Name(s)
Placebo formula
Intervention Description
1 sachet per day for 4 months
Primary Outcome Measure Information:
Title
Inflammation status
Description
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Time Frame
At the beginning of the treatment
Title
Inflammation status
Description
A blood sample will be collected and analised for C-reactive protein and tumor necrosis factor alfa (TNF alfa)
Time Frame
After 4 months of treatment
Title
Muscle strength evaluation
Description
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
Time Frame
At the beginning of the treatment
Title
Muscle strength evaluation
Description
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
Time Frame
After 4 months of treatment
Title
body composition assessment
Description
Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).
Time Frame
At the beginning of the treatment
Title
body composition assessment
Description
Body composition represented by fat free mass and fat mass were measured using a Lunar Prodigy DXA (GE Medical Systems, WI, USA).
Time Frame
After 4 months of treatment
Title
Physical performance assessment
Description
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.
Time Frame
At the beginning of the treatment
Title
Physical performance assessment
Description
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.
Time Frame
After 4 months of treatment
Title
Gut permeability.
Description
A blood sample will be collected and analised for indican
Time Frame
At the beginning of the treatment
Title
Gut permeability.
Description
A blood sample will be collected and analised for indican
Time Frame
After 4 months of treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
85 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Mariangela Rondanelli, MD
Phone
0382381739
Email
mariangela.rondanelli@unipv.it
Facility Information:
Facility Name
l'Istituto di Riabilitazione e cura "Santa Margherita" di Pavia, Azienda di Servizi alla Persona (ASP).
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mariangela Rondanelli, MD
Phone
0382381739
Email
mariangela.rondanelli@unipv.it
12. IPD Sharing Statement
Learn more about this trial
From the Gut to the Strut: Reducing Inflammation for Healthy Muscles
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