Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 3
- 试验地点
- 1
- 主要终点
- Brain carnosine change
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Supportive Care
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Carnosine
Carnosine, capsulle, 2 g/day, 8 weeks
干预措施: Carnosine, capsulle, 2 g/day, 8 weeks (Dietary Supplement)
结局指标
主要结局
Brain carnosine change
时间窗: Baseline vs. eight weeks
Monitor change in brain carnosine levels
次要结局
- Change in neuromuscular performance for autonomic dysfunction (Ewing)(Baseline vs. eight weeks)
- Change in blood clinical chemistry panel(Baseline vs. eight weeks)
- Change in multidimensional fatigue(Baseline vs. eight weeks)
- Health-related quality of life with SF36 Questionnaire change(Baseline vs. eight weeks)
研究者
Sergej Ostojic
University Professor
University of Novi Sad, Faculty of Sport and Physical Education