Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Multiple Sclerosis

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


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Carnosine<br>Carnosine, capsulle, 2 g/day, 8 weeks | Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks<br>* We will administer supplemental carnosine (2 grams per day) for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Brain carnosine change | Monitor change in brain carnosine levels | Baseline vs. eight weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Health-related quality of life with SF36 Questionnaire change | Monitor change in health-related quality of life with SF36 Questionnaire | Baseline vs. eight weeks | 
| Change in neuromuscular performance for autonomic dysfunction (Ewing) | Monitor change in neuromuscular performance for autonomic dysfunction (Ewing) | Baseline vs. eight weeks | 
| Change in multidimensional fatigue | Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire | Baseline vs. eight weeks | 
| Change in blood clinical chemistry panel | Lactic acid change in mmol/L | Baseline vs. eight weeks |