Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)

Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis

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.

Study Overview

• Status: Completed
• Conditions: Multiple Sclerosis
• Intervention / Treatment: Dietary supplement: Carnosine, capsulle, 2 g/day, 8 weeks

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 Type: Interventional
• Enrollment (Actual): 3
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Serbia
  • Vojvodina
    • Novi Sad, Vojvodina, Serbia, 21000
      • Applied Bioenergetics Lab at Faculty of Sport and PE

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 63 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Brain carnosine change	Monitor change in brain carnosine levels	Baseline vs. eight weeks

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Health-related quality of life with SF36 Questionnaire change	Monitor change in health-related quality of life with SF36 Questionnaire	Baseline vs. eight weeks
Change in neuromuscular performance for autonomic dysfunction (Ewing)	Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)	Baseline vs. eight weeks
Change in multidimensional fatigue	Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire	Baseline vs. eight weeks
Change in blood clinical chemistry panel	Lactic acid change in mmol/L	Baseline vs. eight weeks

Collaborators and Investigators

• Sponsor: University of Novi Sad, Faculty of Sport and Physical Education
• Collaborators: CarnoMed
• Investigators: Principal Investigator: Sergej Ostojic, MD, PhD, University of Novi Sad

Publications and helpful links

General Publications

• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): June 15, 2019
• Primary Completion (Actual): November 1, 2019
• Study Completion (Actual): December 1, 2019

Study Registration Dates

• First Submitted: June 18, 2019
• First Submitted That Met QC Criteria: June 20, 2019
• First Posted (Actual): June 24, 2019

Study Record Updates

• Last Update Posted (Actual): March 24, 2020
• Last Update Submitted That Met QC Criteria: March 23, 2020
• Last Verified: March 1, 2020

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Nervous System Diseases; Immune System Diseases; Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Demyelinating Diseases; Autoimmune Diseases; Multiple Sclerosis; Sclerosis
• Other Study ID Numbers: CM-03CS/2019

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD 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
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No