Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)
Primary Purpose
Multiple Sclerosis
Status
Completed
Phase
Not Applicable
Locations
Serbia
Study Type
Interventional
Intervention
Carnosine, capsulle, 2 g/day, 8 weeks
Sponsored by

About this trial
This is an interventional supportive care trial for Multiple Sclerosis
Eligibility Criteria
Inclusion Criteria:
- Age ≥ 18 years
- Body mass index 19 - 30 kg/m2
- Free of major chronic diseases or acute disorders besides MS
- Fulfilled 2017 McDonald Criteria for the diagnosis of MS
Exclusion Criteria:
- Pregnancy
- Psychiatric comorbidity
- Use of dietary supplements within 4 weeks before study commences
- Unwillingness to return for follow-up analysis
- Abnormal values for lab clinical chemistry (> 2 SD)
- Immunotherapy for the past 6 months
- Treated with systemic corticosteroids during the 30 days before study commences
Sites / Locations
- Applied Bioenergetics Lab at Faculty of Sport and PE
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Carnosine
Arm Description
Carnosine, capsulle, 2 g/day, 8 weeks
Outcomes
Primary Outcome Measures
Brain carnosine change
Monitor change in brain carnosine levels
Secondary Outcome Measures
Health-related quality of life with SF36 Questionnaire change
Monitor change in health-related quality of life with SF36 Questionnaire
Change in neuromuscular performance for autonomic dysfunction (Ewing)
Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)
Change in multidimensional fatigue
Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire
Change in blood clinical chemistry panel
Lactic acid change in mmol/L
Full Information
NCT ID
NCT03995810
First Posted
June 18, 2019
Last Updated
March 23, 2020
Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
Collaborators
CarnoMed
1. Study Identification
Unique Protocol Identification Number
NCT03995810
Brief Title
Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
Acronym
CARMUS
Official Title
Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
Study Type
Interventional
2. Study Status
Record Verification Date
March 2020
Overall Recruitment Status
Completed
Study Start Date
June 15, 2019 (Actual)
Primary Completion Date
November 1, 2019 (Actual)
Study Completion Date
December 1, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Novi Sad, Faculty of Sport and Physical Education
Collaborators
CarnoMed
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
Low levels of tissue carnosine and mitochondrial dysfunction appears to accompany multiple sclerosis (MS), with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
Detailed Description
Multiple sclerosis (MS) is a complex autoimmune disorder that affects millions of people around the world, negatively interfering with different aspects of health and everyday life. Being the most frequently seen demyelinating disease, MS prevalence varies considerably, from high levels in North America and Europe (> 100/100,000 inhabitants) to low rates in Eastern Asia and sub-Saharan Africa (2/100,000 population). Due to its rather high prevalence in developed countries, the development of effective and applicable strategies to prevent or manage MS becomes a must for the medical community. Among other factors, it appears that low levels of tissue carnosine and mitochondrial dysfunction accompany MS, with oral carnosine might be applicable to tackle impaired bioenergetics and oxidative stress in MS, and perhaps win back neuromuscular function. However, several formulations of carnosine have shown limited applicability due to restraints in brain delivery or tissue performance thus pushing both industry and researchers to find bioavailable and effective formulation of carnosine. No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS. Here, we will evaluate the impact of supplemental carnosine on neuromuscular performance, brain biomarkers of carnosine metabolism, and health-related quality of life in a case series of patients with MS.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Multiple Sclerosis
7. Study Design
Primary Purpose
Supportive Care
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
3 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Carnosine
Arm Type
Experimental
Arm Description
Carnosine, capsulle, 2 g/day, 8 weeks
Intervention Type
Dietary Supplement
Intervention Name(s)
Carnosine, capsulle, 2 g/day, 8 weeks
Intervention Description
We will administer supplemental carnosine (2 grams per day) for 8 weeks
Primary Outcome Measure Information:
Title
Brain carnosine change
Description
Monitor change in brain carnosine levels
Time Frame
Baseline vs. eight weeks
Secondary Outcome Measure Information:
Title
Health-related quality of life with SF36 Questionnaire change
Description
Monitor change in health-related quality of life with SF36 Questionnaire
Time Frame
Baseline vs. eight weeks
Title
Change in neuromuscular performance for autonomic dysfunction (Ewing)
Description
Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)
Time Frame
Baseline vs. eight weeks
Title
Change in multidimensional fatigue
Description
Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire
Time Frame
Baseline vs. eight weeks
Title
Change in blood clinical chemistry panel
Description
Lactic acid change in mmol/L
Time Frame
Baseline vs. eight weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Age ≥ 18 years
Body mass index 19 - 30 kg/m2
Free of major chronic diseases or acute disorders besides MS
Fulfilled 2017 McDonald Criteria for the diagnosis of MS
Exclusion Criteria:
Pregnancy
Psychiatric comorbidity
Use of dietary supplements within 4 weeks before study commences
Unwillingness to return for follow-up analysis
Abnormal values for lab clinical chemistry (> 2 SD)
Immunotherapy for the past 6 months
Treated with systemic corticosteroids during the 30 days before study commences
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sergej Ostojic, MD, PhD
Organizational Affiliation
University of Novi Sad
Official's Role
Principal Investigator
Facility Information:
Facility Name
Applied Bioenergetics Lab at Faculty of Sport and PE
City
Novi Sad
State/Province
Vojvodina
ZIP/Postal Code
21000
Country
Serbia
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Data will be available after request to PI
IPD Sharing Time Frame
Six months after a completion of the study.
IPD Sharing Access Criteria
No specific sharing access criteria
Citations:
PubMed Identifier
29454153
Citation
Keytsman C, Blancquaert L, Wens I, Missine M, Noten PV, Vandenabeele F, Derave W, Eijnde BO. Muscle carnosine in experimental autoimmune encephalomyelitis and multiple sclerosis. Mult Scler Relat Disord. 2018 Apr;21:24-29. doi: 10.1016/j.msard.2018.02.013. Epub 2018 Feb 11.
Results Reference
background
PubMed Identifier
26036009
Citation
Sariev AK, Abaimov DA, Tankevich MV, Pantyukhova EY, Prokhorov DI, Fedorova TN, Lopachev AV, Stvolinskii SL, Konovalova EV, Seifulla RD. [Experimental study of the basic pharmacokinetic characteristics of dipeptide carnosine and its efficiency of penetration into brain tissues]. Eksp Klin Farmakol. 2015;78(3):30-5. Russian.
Results Reference
background
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Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
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