Clinical trial NCT03995810: Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
Official title: Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Multiple Sclerosis
Lead sponsor: University of Novi Sad, Faculty of Sport and Physical Education
Sponsor class: OTHER
Collaborators: name: CarnoMed
First posted: 2019-06-24
Enrollment: 3
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SUPPORTIVE_CARE

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.

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

Primary outcomes:
measure: Brain carnosine change
timeFrame: Baseline vs. eight weeks
Secondary outcomes:
measure: Health-related quality of life with SF36 Questionnaire change
timeFrame: Baseline vs. eight weeks
measure: Change in neuromuscular performance for autonomic dysfunction (Ewing)
timeFrame: Baseline vs. eight weeks
measure: Change in multidimensional fatigue
timeFrame: Baseline vs. eight weeks
measure: Change in blood clinical chemistry panel
timeFrame: Baseline vs. eight weeks
Other outcomes:
Locations:
city: Novi Sad
country: Serbia
facility: Applied Bioenergetics Lab at Faculty of Sport and PE
state: Vojvodina
Study officials:
affiliation: University of Novi Sad
name: Sergej Ostojic, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.