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出境医 / 临床实验 / Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)

Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis (CARMUS)

Study Description
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.

Condition or disease Intervention/treatment Phase
Multiple Sclerosis Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks Not Applicable

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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 3 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
Actual Study Start Date : June 15, 2019
Actual Primary Completion Date : November 1, 2019
Actual Study Completion Date : December 1, 2019
Arms and Interventions
Arm Intervention/treatment
Experimental: Carnosine
Carnosine, capsulle, 2 g/day, 8 weeks
 Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks
We will administer supplemental carnosine (2 grams per day) for 8 weeks
Outcome Measures
Primary Outcome Measures :
  1. Brain carnosine change [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in brain carnosine levels


Secondary Outcome Measures :
  1. Health-related quality of life with SF36 Questionnaire change [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in health-related quality of life with SF36 Questionnaire

  2. Change in neuromuscular performance for autonomic dysfunction (Ewing) [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)

  3. Change in multidimensional fatigue [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire

  4. Change in blood clinical chemistry panel [ Time Frame: Baseline vs. eight weeks ]
    Lactic acid change in mmol/L


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations

Locations
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Serbia
Applied Bioenergetics Lab at Faculty of Sport and PE
Novi Sad, Vojvodina, Serbia, 21000
Sponsors and Collaborators
University of Novi Sad, Faculty of Sport and Physical Education
CarnoMed
Investigators
Layout table for investigator information
Principal Investigator: Sergej Ostojic, MD, PhD University of Novi Sad
Tracking Information
First Submitted Date  ICMJE June 18, 2019
First Posted Date  ICMJE June 24, 2019
Last Update Posted Date March 24, 2020
Actual Study Start Date  ICMJE June 15, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: June 20, 2019) 		Brain carnosine change [ Time Frame: Baseline vs. eight weeks ]
Monitor change in brain carnosine levels
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: June 20, 2019)
  • Health-related quality of life with SF36 Questionnaire change [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in health-related quality of life with SF36 Questionnaire
  • Change in neuromuscular performance for autonomic dysfunction (Ewing) [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in neuromuscular performance for autonomic dysfunction (Ewing)
  • Change in multidimensional fatigue [ Time Frame: Baseline vs. eight weeks ]
    Monitor change in multidimensional Multidimensional Fatigue Inventory (MFI) 20-item questionnaire
  • Change in blood clinical chemistry panel [ Time Frame: Baseline vs. eight weeks ]
    Lactic acid change in mmol/L
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis
Official Title  ICMJE Oral Carnosine for Neuromuscular Performance, Brain Biomarkers of Carnosine Metabolism and Health-related Quality of Life in Multiple Sclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Condition  ICMJE Multiple Sclerosis
Intervention  ICMJE Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks
We will administer supplemental carnosine (2 grams per day) for 8 weeks
Study Arms  ICMJE Experimental: Carnosine
Carnosine, capsulle, 2 g/day, 8 weeks
Intervention: Dietary Supplement: Carnosine, capsulle, 2 g/day, 8 weeks
Publications *
  • Keytsman C, Blancquaert L, Wens I, Missine M, Noten PV, Vandenabeele F, Derave W, Eijnde BO. Muscle carnosine in experimental autoimmune encephalomyelitis and multiple sclerosis. Mult Scler Relat Disord. 2018 Apr;21:24-29. doi: 10.1016/j.msard.2018.02.013. Epub 2018 Feb 11.
  • Sariev AK, Abaimov DA, Tankevich MV, Pantyukhova EY, Prokhorov DI, Fedorova TN, Lopachev AV, Stvolinskii SL, Konovalova EV, Seifulla RD. [Experimental study of the basic pharmacokinetic characteristics of dipeptide carnosine and its efficiency of penetration into brain tissues]. Eksp Klin Farmakol. 2015;78(3):30-5. Russian.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 20, 2019) 		3
Original Estimated Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE December 1, 2019
Actual Primary Completion Date November 1, 2019   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 65 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Serbia
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03995810
Other Study ID Numbers  ICMJE CM-03CS/2019
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Data will be available after request to PI
Supporting Materials: Study Protocol
Time Frame: Six months after a completion of the study.
Access Criteria: No specific sharing access criteria
Responsible Party Sergej Ostojic, University of Novi Sad, Faculty of Sport and Physical Education
Study Sponsor  ICMJE University of Novi Sad, Faculty of Sport and Physical Education
Collaborators  ICMJE CarnoMed
Investigators  ICMJE
Principal Investigator: Sergej Ostojic, MD, PhD University of Novi Sad
PRS Account University of Novi Sad, Faculty of Sport and Physical Education
Verification Date March 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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