Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

NCT03995810 | Completed

• 1 other identifier: CM-03CS/2019
• Study Type: interventional
• Target: 3
• Locations: 1 country
• Sites: 1

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.

Conditions

Multiple Sclerosis

Outcome Measures

Primary Outcomes (1)

• Brain carnosine change

  Monitor change in brain carnosine levels

  Baseline vs. eight weeks

Secondary Outcomes (4)

• Health-related quality of life with SF36 Questionnaire change

  Baseline vs. eight weeks

• Change in neuromuscular performance for autonomic dysfunction (Ewing)

  Baseline vs. eight weeks

• Change in multidimensional fatigue

  Baseline vs. eight weeks

• Change in blood clinical chemistry panel

  Baseline vs. eight weeks

Study Arms (1)

Carnosine

EXPERIMENTAL

Carnosine, capsulle, 2 g/day, 8 weeks

Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks

Interventions

Carnosine, capsulle, 2 g/day, 8 weeks DIETARY_SUPPLEMENT

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

Carnosine

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Novi Sad, Faculty of Sport and Physical Education: lead
• CarnoMed: collaborator

Study Sites (1)

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

Location

Related 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.

  PMID: 29454153 BACKGROUND

• 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.

  PMID: 26036009 BACKGROUND

MeSH Terms

Conditions

Multiple Sclerosis

Interventions

Carnosine

Condition Hierarchy (Ancestors)

Demyelinating Autoimmune Diseases, CNS; Autoimmune Diseases of the Nervous System; Nervous System Diseases; Demyelinating Diseases; Autoimmune Diseases; Immune System Diseases

Intervention Hierarchy (Ancestors)

Neuropeptides; Peptides; Amino Acids, Peptides, and Proteins; Dipeptides; Oligopeptides; Nerve Tissue Proteins; Proteins

Study Officials

• Sergej Ostojic, MD, PhD

  University of Novi Sad

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: University Professor

Study Record Dates

• First Submitted: June 18, 2019
• First Posted: June 24, 2019
• Study Start: June 15, 2019
• Primary Completion: November 1, 2019
• Study Completion: December 1, 2019
• Last Updated: March 24, 2020

Record last verified: 2020-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Six months after a completion of the study.
• Access Criteria: No specific sharing access criteria

Locations

SE (1)