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OpenTrials
Completed

NCT Number: NCT03995810

Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

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.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Applied Bioenergetics Lab at Faculty of Sport and PE

Novi Sad, Vojvodina, 21000, Serbia

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Carnosine, capsulle, 2 g/day, 8 weeks

Dietary Supplement

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

Primary outcomes

  1. Brain carnosine change

    Time frame: Baseline vs. eight weeks

    Monitor change in brain carnosine levels

Secondary outcomes

  1. Health-related quality of life with SF36 Questionnaire change

    Time frame: Baseline vs. eight weeks

    Monitor change in health-related quality of life with SF36 Questionnaire

  2. Change in neuromuscular performance for autonomic dysfunction (Ewing)

    Time frame: Baseline vs. eight weeks

    Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)

  3. Change in multidimensional fatigue

    Time frame: Baseline vs. eight weeks

    Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire

  4. Change in blood clinical chemistry panel

    Time frame: Baseline vs. eight weeks

    Lactic acid change in mmol/L

Sponsors and collaborators

Lead sponsor

University of Novi Sad, Faculty of Sport and Physical Education

Other

Collaborators

  • CarnoMed

Registry information

Official study title

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

Acronym: CARMUS

Important dates

Study start
2019
Primary completion
2019
Study completion
2019
First posted
Jun 24, 2019
Registry last updated
Mar 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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