Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

NCT ID: NCT03995810

Last Updated: 2020-03-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 3 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-06-15
• Study Completion Date: 2019-12-01

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.

Conditions

Multiple Sclerosis

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Carnosine

Carnosine, capsulle, 2 g/day, 8 weeks

Group Type: EXPERIMENTAL

Carnosine, capsulle, 2 g/day, 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

We will administer supplemental carnosine (2 grams per day) for 8 weeks

Interventions

Carnosine, capsulle, 2 g/day, 8 weeks

We will administer supplemental carnosine (2 grams per day) for 8 weeks

Intervention Type: DIETARY_SUPPLEMENT

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

CarnoMed

UNKNOWN

Sponsor Role: collaborator

University of Novi Sad, Faculty of Sport and Physical Education

OTHER

Sponsor Role: lead

Responsible Party

Sergej Ostojic

University Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Sergej Ostojic, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University of Novi Sad

Locations

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, Serbia

Countries

Serbia

References

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.

Reference Type: BACKGROUND

PMID: 29454153 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 26036009 (View on PubMed)

Other Identifiers

CM-03CS/2019

Identifier Type: -

Identifier Source: org_study_id