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

Slovak Academy of Sciences

Status: Completed

Conditions: Healthy Volunteers; Mild Cognitive Impairment; Subjective Cognitive Impairment; Parkinson Disease

Treatments: Behavioral: exercise; Dietary Supplement: supplementation with placebo; Dietary Supplement: carnosine supplementation; Behavioral: stretching

Study type: Interventional

Funder types: Other

Identifiers

NCT03330470

15-0253

Details and patient eligibility

About

The purpose of this study is to investigate the beneficial effects of regular exercise and the impact of food supplement carnosine on cognitive, motoric and metabolic functions as well as on specific biologically active substances in volunteers with subjective (SCI) or mild (MCI) cognitive impairment, as well as in patients in early stages of Parkinson's disease. The investigators assume the immediate intervention-associated health benefit for volunteers.

Full description

Standard Operating Procedures for patient recruitment, data collection, data management, data analysis routinely used in Biomedical Research Center, Slovak Academy of Sciences, University Hospital Bratislava and Comenius University, Bratislava will be employed. Gait and balance parameters will be examined and analysed at the Department of Behavioural Neuroscience, Centre of Experimental Medicine, Slovak Academy of Sciences, Bratislava, Slovakia Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

Enrollment: 26 patients

Sex: All

Ages: 55 to 80 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

• 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

Exclusion criteria

• Serious systemic cardiovascular, hepatic, renal disease, cancer
• Lack of compliance

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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26 participants in 4 patient groups

exercise and carnosine supplementation

Experimental group

Description:

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

Treatment:

Dietary Supplement: carnosine supplementation

Behavioral: exercise

exercise and supplementation with placebo

Experimental group

Description:

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

Treatment:

Dietary Supplement: supplementation with placebo

Behavioral: exercise

stretching controls and carnosine supplementation

Experimental group

Description:

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

Treatment:

Behavioral: stretching

Dietary Supplement: carnosine supplementation

stretching controls and supplementation with placebo

Experimental group

Description:

stretching controls: participants will be subjected to 4 months of supervised stretching program supplementation with placebo: participants will be instructed to take placebo 2 times daily

Treatment:

Behavioral: stretching

Dietary Supplement: supplementation with placebo