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

CompletedNot a drug-phase studyMS (type not specified)NCT03995810

What it found

No results found

We found no results in the registry or in papers.

This trial finished 7 years ago. We found no results in the registry or in any paper that cites it.

What was tested

Treatment tested

  • Carnosine

What it measured

Main measures

  • Brain carnosine change

    Baseline vs. eight weeks

Other measures (4)

  • Health-related quality of life with SF36 Questionnaire change

    Baseline vs. eight weeks

    Quality of life (reported by participants)
  • Change in neuromuscular performance for autonomic dysfunction (Ewing)

    Baseline vs. eight weeks

  • Change in multidimensional fatigue

    Baseline vs. eight weeks

    Fatigue
  • Change in blood clinical chemistry panel

    Baseline vs. eight weeks

Who could take part

MS (type not specified) · 18 to 65

Show the full 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

As registered. Criteria can change, so ask the trial team or your neurologist.

About this trial

In the sponsor's words

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.

Papers

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History

    1. Started

      Jun 2019

    2. Main results due

      Nov 2019

    3. Finished

      Dec 2019

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