Multiple Sclerosis
Conditions
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.
Interventions
DIETARY_SUPPLEMENTCarnosine, capsulle, 2 g/day, 8 weeks
We will administer supplemental carnosine (2 grams per day) for 8 weeks
Sponsors
CarnoMed
University of Novi Sad, Faculty of Sport and Physical Education
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Brain carnosine change | Baseline vs. eight weeks | Monitor change in brain carnosine levels |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Health-related quality of life with SF36 Questionnaire change | Baseline vs. eight weeks | Monitor change in health-related quality of life with SF36 Questionnaire |
| Change in neuromuscular performance for autonomic dysfunction (Ewing) | Baseline vs. eight weeks | Monitor change in neuromuscular performance for autonomic dysfunction (Ewing) |
| Change in multidimensional fatigue | Baseline vs. eight weeks | Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire |
| Change in blood clinical chemistry panel | Baseline vs. eight weeks | Lactic acid change in mmol/L |
Countries
Serbia
Outcome results
None listed