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

NCT03330470 | Completed

• 1 other identifier: 15-0253
• Study Type: interventional
• Target: 26
• Locations: 2 countries
• Sites: 3

Brief Summary

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.

Conditions

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

Keywords

Parkinson's disease; exercise training; motor functions; cognitive functions

Outcome Measures

Primary Outcomes (3)

• glucose tolerance

  changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)

  up to 36 months

• learning/working memory

  exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100)

  up to 36 months

• Balance parameter (Berg Balance Scale)

  Exercise related changes in ballance will be examined with the Berg Balance Scale test (max score 56)

  up to 36 months

Secondary Outcomes (16)

• habitual physical activity

  up to 36 months

• physical fitness

  up to 36 months

• Gait parameters (Walking speed)

  24 months

• Gait parameter (Stance time)

  24 months

• Gait parameter (step length)

  24 months

Study Arms (4)

exercise and carnosine supplementation

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

Behavioral: exercise; Dietary Supplement: carnosine supplementation

exercise and supplementation with placebo

EXPERIMENTAL

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

Behavioral: exercise; Dietary Supplement: supplementation with placebo

stretching controls and carnosine supplementation

EXPERIMENTAL

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

Dietary Supplement: carnosine supplementation; Behavioral: stretching

stretching controls and supplementation with placebo

EXPERIMENTAL

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

Behavioral: stretching; Dietary Supplement: supplementation with placebo

Interventions

exercise BEHAVIORAL

participants will be subjected to 4 months supervised exercise intervention

exercise and carnosine supplementation; exercise and supplementation with placebo

carnosine supplementation DIETARY_SUPPLEMENT

participants will be instructed to take carnosine 2 times daily

exercise and carnosine supplementation; stretching controls and carnosine supplementation

stretching BEHAVIORAL

participants will be subjected to 4 months supervised stretching program

stretching controls and carnosine supplementation; stretching controls and supplementation with placebo

supplementation with placebo DIETARY_SUPPLEMENT

participants will be instructed to take placebo 2 times daily

exercise and supplementation with placebo; stretching controls and supplementation with placebo

Eligibility Criteria

• Age: 55 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• Slovak Academy of Sciences: lead
• Comenius University: collaborator
• University Hospital Bratislava: collaborator
• National Cheng Kung University: collaborator

Study Sites (3)

University Hospital Bratislava, Comenius University

Bratislava, 81369, Slovakia

Location

Biomedical Research Center, Slovak Academy of Sciences

Bratislava, 84505, Slovakia

Location

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

Tainan, Tainan, 701, Taiwan

Location

MeSH Terms

Conditions

Cognitive Dysfunction; Parkinson Disease

Interventions

Exercise; Dietary Supplements

Condition Hierarchy (Ancestors)

Cognition Disorders; Neurocognitive Disorders; Mental Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Movement Disorders; Synucleinopathies; Neurodegenerative Diseases

Intervention Hierarchy (Ancestors)

Motor Activity; Movement; Musculoskeletal Physiological Phenomena; Musculoskeletal and Neural Physiological Phenomena; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Peter Turčáni, Prof., MD, PhD

  University Hospital Bratislava, Comenius University, Bratislava,

  PRINCIPAL INVESTIGATOR

• Peter Valkovič, Prof., MD, PhD

  University Hospital Bratislava, Comenius University, Bratislava,

  PRINCIPAL INVESTIGATOR

• Barbara Ukropcová, Assoc. Prof., MD, PhD

  Biomedical Research Center, Slovak Academy of Sciences,

  PRINCIPAL INVESTIGATOR

• Jozef Ukropec, DrSc, PhD

  Biomedical Research Center, Slovak Academy of Sciences,

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Prof. MD, PhD

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: November 6, 2017
• Study Start: January 1, 2017
• Primary Completion: June 30, 2023
• Study Completion: September 30, 2023
• Last Updated: May 28, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

SL (2); TW (1)