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Oral Carnosine for Neuromuscular Performance in Multiple Sclerosis

Plain-language guide to NCT03995810: not phased interventional trial of Carnosine, multiple sclerosis, 3 participants. Who took part, design and what was measured.

Key Facts

Registry ID
NCT03995810
Phase
not phased
Status
completed
Start
2019-06-15
Completion (planned or actual)
2019-11-01
Participants
3 (actual)
Design
na, open label (everyone knows who gets what), supportive_care
Conditions studied
Multiple Sclerosis
Results posted
not yet

What This Study Did, in Plain Language

What Was Tested

In this not phased trial, researchers set out to test Carnosine for multiple sclerosis.

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.

No human studies so far evaluated the impact of innovative carnosine formulation (Karnozin EXTRA) in MS.

It had 1 arm (groups): Carnosine (experimental).

The registry classes the interventions as dietary supplement.

More on the Plan

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).

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.

Who Took Part

The registry lists 3 actual participants took part.

It was open to people of any sex aged from 18 years up to 65 years.

Healthy volunteers were not accepted; participants needed the condition being studied.

Examples of who could join: 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.

The full record lists 4 inclusion and 7 exclusion criteria; among the exclusions: psychiatric comorbidity; use of dietary supplements within 4 weeks before study commences; unwillingness to return for follow-up analysis.

How the Study Was Run

The set-up was single-group and open-label.

Being open-label, the Carnosine study did not mask who received what.

Everyone received the same intervention, so there was no separate comparison group inside the trial.

It started in 2019-06-15 with completion listed for 2019-11-01.

It ran at 1 site in Serbia.

Its stated primary purpose is supportive care.

What Was Measured

The main thing measured (primary outcome): Brain carnosine change (time frame: Baseline vs. eight weeks).

It also tracked 4 secondary outcomes, for example Health-related quality of life with SF36 Questionnaire change, Change in neuromuscular performance for autonomic dysfunction (Ewing), Change in multidimensional fatigue and Change in blood clinical chemistry panel.

What This Means in Plain Language

Put simply, this is a not phased trial of Carnosine in 3 people with multiple sclerosis.

Its size is small, so on its own it can only give an early look.

The trial is marked completed; no results are posted to the registry yet, so nothing here describes outcomes.

More context: the Carnosine compound page, Multiple sclerosis research.

Our Notes on the Compound

Carnosine: A dipeptide of beta-alanine and histidine found in muscle and brain; studied as a supplement in human trials.

Related Pages

Source: ClinicalTrials.gov record. This explanation is written by PeptideWhiz from the public record. For research and education only. Not medical advice; no dosing information is given.