Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

Multiple Sclerosis Clinical Trial

— CARMUS  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03995810
• Other study ID #: CM-03CS/2019
• Status: Completed
• Phase: N/A
• Start date: June 15, 2019
• Est. completion date: December 1, 2019

Study information

• Verified date: March 2020
• Source: University of Novi Sad, Faculty of Sport and Physical Education
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 3
• Est. completion date: December 1, 2019
• Est. primary completion date: November 1, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

• Multiple Sclerosis
• Sclerosis

Intervention

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

Locations

Country	Name	City	State
Serbia	Applied Bioenergetics Lab at Faculty of Sport and PE	Novi Sad	Vojvodina

Sponsors (2)

Lead Sponsor	Collaborator
University of Novi Sad, Faculty of Sport and Physical Education	CarnoMed

Country where clinical trial is conducted

Serbia, 

References & Publications (2)

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. — View 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. — View Citation

Outcome

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