Trial | NCT03995810  Report issue

Title

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

  • Phase

    N/A

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    3
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.
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.
Study Started
Jun 15
2019
Primary Completion
Nov 01
2019
Study Completion
Dec 01
2019
Last Update
Mar 24
2020

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

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

Carnosine Experimental

Carnosine, capsulle, 2 g/day, 8 weeks

Criteria 

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
No Results Posted