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

NCT ID: NCT03330470

Last Updated: 2025-05-28

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

26 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-01-01

Study Completion Date

2023-09-30

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Subjective Cognitive Impairment Mild Cognitive Impairment Parkinson Disease Healthy Volunteers

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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exercise and carnosine supplementation

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

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

participants will be subjected to 4 months supervised exercise intervention

carnosine supplementation

Intervention Type DIETARY_SUPPLEMENT

participants will be instructed to take carnosine 2 times daily

exercise and supplementation with placebo

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

Group Type EXPERIMENTAL

exercise

Intervention Type BEHAVIORAL

participants will be subjected to 4 months supervised exercise intervention

supplementation with placebo

Intervention Type DIETARY_SUPPLEMENT

participants will be instructed to take placebo 2 times daily

stretching controls and carnosine supplementation

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

Group Type EXPERIMENTAL

carnosine supplementation

Intervention Type DIETARY_SUPPLEMENT

participants will be instructed to take carnosine 2 times daily

stretching

Intervention Type BEHAVIORAL

participants will be subjected to 4 months supervised stretching program

stretching controls and supplementation with placebo

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

Group Type EXPERIMENTAL

stretching

Intervention Type BEHAVIORAL

participants will be subjected to 4 months supervised stretching program

supplementation with placebo

Intervention Type DIETARY_SUPPLEMENT

participants will be instructed to take placebo 2 times daily

Interventions

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exercise

participants will be subjected to 4 months supervised exercise intervention

Intervention Type BEHAVIORAL

carnosine supplementation

participants will be instructed to take carnosine 2 times daily

Intervention Type DIETARY_SUPPLEMENT

stretching

participants will be subjected to 4 months supervised stretching program

Intervention Type BEHAVIORAL

supplementation with placebo

participants will be instructed to take placebo 2 times daily

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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
Minimum Eligible Age

55 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Comenius University

OTHER

Sponsor Role collaborator

University Hospital Bratislava

OTHER

Sponsor Role collaborator

National Cheng Kung University

OTHER

Sponsor Role collaborator

Slovak Academy of Sciences

OTHER_GOV

Sponsor Role lead

Responsible Party

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Barbara Ukropcová, MD, PhD

Prof. MD, PhD

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Peter Turčáni, Prof., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava, Comenius University, Bratislava,

Peter Valkovič, Prof., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Bratislava, Comenius University, Bratislava,

Barbara Ukropcová, Assoc. Prof., MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center, Slovak Academy of Sciences,

Jozef Ukropec, DrSc, PhD

Role: PRINCIPAL_INVESTIGATOR

Biomedical Research Center, Slovak Academy of Sciences,

Locations

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University Hospital Bratislava, Comenius University

Bratislava, , Slovakia

Site Status

Biomedical Research Center, Slovak Academy of Sciences

Bratislava, , Slovakia

Site Status

Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University

Tainan City, Tainan, Taiwan

Site Status

Countries

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Slovakia Taiwan

Other Identifiers

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15-0253

Identifier Type: -

Identifier Source: org_study_id

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