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

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.

Study Overview

• Status: Unknown
• Conditions: Parkinson Disease; Healthy Volunteers; Mild Cognitive Impairment; Subjective Cognitive Impairment
• Intervention / Treatment: Behavioral: exercise; Dietary supplement: carnosine supplementation; Dietary supplement: supplementation with placebo; Behavioral: stretching

Detailed 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.

Statistical analysis will be employed to address the primary and secondary objectives, as specified in the study protocol.

• Study Type: Interventional
• Enrollment (Anticipated): 100
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Barbara Ukropcová, Assoc. Prof., MD, PhD; Phone Number: +421 2 32295 2261; Email: barbara.ukropcova@savba.sk

Study Locations

• Slovakia
  • Bratislava, Slovakia, 81369
    • Active, not recruiting
    • University Hospital Bratislava, Comenius University
  • Bratislava, Slovakia, 84505
    • Recruiting
    • Biomedical Research Center, Slovak Academy of Sciences
    • Contact: Barbara Ukropcová, Assoc. Prof., MD, PhD; Phone Number: +421 2 32295 2261; Email: barbara.ukropcova@savba.sk
    • Principal Investigator: Jozef Ukropec, DrSC., PhD
    • Sub-Investigator: Lucia Slobodová, Mgr.
    • Sub-Investigator: Martin Schon, MD
• Taiwan
  • Tainan
    • Tainan City, Tainan, Taiwan, 701
      • Active, not recruiting
      • Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 55 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Quadruple

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: exercise and carnosine supplementation; exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily	Behavioral: exercise; participants will be subjected to 3 months supervised exercise intervention; Dietary supplement: carnosine supplementation; participants will be instructed to take carnosine 2 times daily
Experimental: exercise and supplementation with placebo; exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily	Behavioral: exercise; participants will be subjected to 3 months supervised exercise intervention; Dietary supplement: supplementation with placebo; participants will be instructed to take placebo 2 times daily
Experimental: stretching controls and carnosine supplementation; stretching controls: participants will be subjected to 3 months supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily	Dietary supplement: carnosine supplementation; participants will be instructed to take carnosine 2 times daily; Behavioral: stretching; participants will be subjected to 3 months supervised stretching program
Experimental: stretching controls and supplementation with placebo; stretching controls: participants will be subjected to 3 months supervised stretching program supplementation with placebo: participants will be instructed to take placebo 2 times daily	Dietary supplement: supplementation with placebo; participants will be instructed to take placebo 2 times daily; Behavioral: stretching; participants will be subjected to 3 months supervised stretching program

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
motoric functions - Berg Balance Scale	exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)	up to 36 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
habitual physical activity	Habitual physical activity will be determined with accelerometers	up to 36 months
physical fitness	Submaximal aerobic capacity will be determined with one mile walk test	up to 36 months

Collaborators and Investigators

• Sponsor: Slovak Academy of Sciences
• Collaborators: National Cheng Kung University; Comenius University; University Hospital Bratislava
• Investigators: Principal Investigator: 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,

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2017
• Primary Completion (Anticipated): December 31, 2020
• Study Completion (Anticipated): December 31, 2020

Study Registration Dates

• First Submitted: October 17, 2017
• First Submitted That Met QC Criteria: October 30, 2017
• First Posted (Actual): November 6, 2017

Study Record Updates

• Last Update Posted (Actual): September 17, 2018
• Last Update Submitted That Met QC Criteria: September 13, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Mental Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Neurocognitive Disorders; Parkinsonian Disorders; Basal Ganglia Diseases; Movement Disorders; Synucleinopathies; Cognition Disorders; Parkinson Disease; Cognitive Dysfunction; Neurodegenerative Diseases
• Other Study ID Numbers: 15-0253

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No