Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)

University of Novi Sad, Faculty of Sport and Physical Education

Status: Completed

Conditions: Multiple Sclerosis

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

Study type: Interventional

Funder types: Other

Identifiers

NCT03995810

CM-03CS/2019

Details and patient eligibility

About

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.

Full 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.

Enrollment: 3 patients

Sex: All

Ages: 18 to 65 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

3 participants in 1 patient group

Carnosine

Experimental group

Description:

Carnosine, capsulle, 2 g/day, 8 weeks

Treatment:

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