Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease

What Was Tested

In this not phased trial, researchers set out to test Carnosine for parkinson's disease.

It had four arms (groups): exercise and carnosine supplementation (experimental), exercise and supplementation with placebo (experimental), stretching controls and carnosine supplementation (experimental) and stretching controls and supplementation with placebo (experimental).

Exercise: participants will be subjected to 4 months of supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily.

Exercise: participants will be subjected to 4 months of supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily.

Stretching controls: participants will be subjected to 4 months of supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily.

The registry classes the interventions as behavioral and dietary supplement.

Who Took Part

The registry lists 26 actual participants took part.

It was open to people of any sex aged from 55 years up to 80 years.

Healthy volunteers could join, not only people with the condition.

Examples of who could join: Signed informed consent. Age 55 - 80 years. Presence of Subjective Cognitive Impairment (SCI), Mild Cognitive Impairment (MCI) or early stage of Parkinson's Disease (Hoehn-Yahr 1st-2nd stage), assessed by experienced neurologist.

The full record lists 3 inclusion and 2 exclusion criteria; among the exclusions: serious systemic cardiovascular, hepatic, renal disease, cancer; lack of compliance.

How the Study Was Run

It was run as a randomized, parallel-group and quadruple-blind study.

The parkinson's disease participants were allocated by chance, so the Carnosine group and the comparison group should start out alike.

Groups ran in parallel: each of the parkinson's disease participants stayed in one arm throughout.

Neither the parkinson's disease participants nor the staff measuring them knew who was on Carnosine, so expectations could not easily colour the readings.

Those kept unaware of assignments: participant, care provider, investigator and outcomes assessor.

It started in 2017-01-01 with completion listed for 2023-06-30.

It ran at 3 sites in Slovakia (2) and Taiwan (1).

Its stated primary purpose is basic science.

What Was Measured

Researchers chose this as the main measure: glucose tolerance (time frame: up to 36 months). learning/working memory (time frame: up to 36 months). Balance parameter (Berg Balance Scale) (time frame: up to 36 months).

It also tracked 16 secondary outcomes, for example habitual physical activity, physical fitness, Gait parameters (Walking speed), Gait parameter (Stance time), Gait parameter (step length) and Postural parameter (magnitude of CoP displacement).

What This Means in Plain Language

Put simply, this is a not phased, randomized trial of Carnosine in 26 people with parkinson's disease.

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, Parkinson's disease research.