We're building a better ClinicalTrials.gov. Check it out and tell us what you think!
Try the New Site
We're building a modernized ClinicalTrials.gov! Visit Beta.ClinicalTrials.gov to try the new functionality.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03995810
Recruitment Status : Completed
First Posted : June 24, 2019
Last Update Posted : March 24, 2020
Sponsor:
Collaborator:
CarnoMed
Information provided by (Responsible Party):
Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks Not Applicable

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.
Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
Actual Study Start Date : June 15, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 1, 2019

Resource links provided by the National Library of Medicine


Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Carnosine
Carnosine, capsulle, 2 g/day, 8 weeks
 Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks
We will administer supplemental carnosine (2 grams per day) for 8 weeks


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Brain carnosine change [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in brain carnosine levels


Secondary Outcome Measures :
  1. Health-related quality of life with SF36 Questionnaire change [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in health-related quality of life with SF36 Questionnaire

  2. Change in neuromuscular performance for autonomic dysfunction (Ewing) [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)

  3. Change in multidimensional fatigue [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire

  4. Change in blood clinical chemistry panel [ Time Frame: Baseline vs. eight weeks ]
    Lactic acid change in mmol/L


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03995810


Locations
Layout table for location information
Serbia
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
CarnoMed
Investigators
Layout table for investigator information
Principal Investigator: Sergej Ostojic, MD, PhD University of Novi Sad
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Sergej Ostojic, University Professor, University of Novi Sad, Faculty of Sport and Physical Education
ClinicalTrials.gov Identifier: NCT03995810    
Other Study ID Numbers: CM-03CS/2019
First Posted: June 24, 2019    Key Record Dates
Last Update Posted: March 24, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be available after request to PI
Supporting Materials: Study Protocol
Time Frame: Six months after a completion of the study.
Access Criteria: No specific sharing access criteria

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
Layout table for MeSH terms
Multiple Sclerosis
Sclerosis
Pathologic Processes
Demyelinating Autoimmune Diseases, CNS
Autoimmune Diseases of the Nervous System
 Nervous System Diseases
Demyelinating Diseases
Autoimmune Diseases
Immune System Diseases