CARMUS: Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

Sponsor

University of Novi Sad, Faculty of Sport and Physical Education (Other)

Overall Status

Completed

CT.gov ID

NCT03995810

Collaborator

CarnoMed (Other)

Enrollment

Location

Arm

5.6

Actual Duration (Months)

0.5

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Multiple Sclerosis	Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks	N/A

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

Study Type:

Interventional

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 :

Jun 15, 2019

Actual Primary Completion Date :

Nov 1, 2019

Actual Study Completion Date :

Dec 1, 2019

Arms and Interventions

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

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

Primary Outcome Measures

Brain carnosine change [Baseline vs. eight weeks]
Monitor change in brain carnosine levels

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 65 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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

Locations

	Site	City	State	Country	Postal Code
1	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

Principal Investigator: Sergej Ostojic, MD, PhD, University of Novi Sad

Study Documents (Full-Text)

None provided.

More Information

Publications

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:

Jun 24, 2019

Last Update Posted:

Mar 24, 2020

Last Verified:

Mar 1, 2020

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Multiple Sclerosis

Sclerosis

Study Results

No Results Posted as of Mar 24, 2020