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

Primary Purpose

Subjective Cognitive Impairment, Mild Cognitive Impairment, Parkinson Disease

Status
Unknown status
Phase
Not Applicable
Locations
International
Study Type
Interventional
Intervention
exercise
carnosine supplementation
stretching
supplementation with placebo
Sponsored by
Slovak Academy of Sciences
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Subjective Cognitive Impairment

Eligibility Criteria

55 Years - 80 Years (Adult, Older Adult)All SexesAccepts 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

Sites / Locations

  • University Hospital Bratislava, Comenius University
  • Biomedical Research Center, Slovak Academy of SciencesRecruiting
  • Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

exercise and carnosine supplementation

exercise and supplementation with placebo

stretching controls and carnosine supplementation

stretching controls and supplementation with placebo

Arm Description

exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily

exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily

stretching controls: participants will be subjected to 3 months supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily

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

Outcomes

Primary Outcome Measures

glucose tolerance
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
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)
motoric functions - Berg Balance Scale
exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)

Secondary Outcome Measures

habitual physical activity
Habitual physical activity will be determined with accelerometers
physical fitness
Submaximal aerobic capacity will be determined with one mile walk test

Full Information

First Posted
October 17, 2017
Last Updated
September 13, 2018
Sponsor
Slovak Academy of Sciences
Collaborators
Comenius University, University Hospital Bratislava, National Cheng Kung University
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1. Study Identification

Unique Protocol Identification Number
NCT03330470
Brief Title
Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Official Title
Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Unknown status
Study Start Date
January 1, 2017 (Actual)
Primary Completion Date
December 31, 2020 (Anticipated)
Study Completion Date
December 31, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Slovak Academy of Sciences
Collaborators
Comenius University, University Hospital Bratislava, National Cheng Kung University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Subjective Cognitive Impairment, Mild Cognitive Impairment, Parkinson Disease, Healthy Volunteers

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
100 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
exercise and carnosine supplementation
Arm Type
Experimental
Arm Description
exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Arm Title
exercise and supplementation with placebo
Arm Type
Experimental
Arm Description
exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily
Arm Title
stretching controls and carnosine supplementation
Arm Type
Experimental
Arm Description
stretching controls: participants will be subjected to 3 months supervised stretching program carnosine supplementation: participants will be instructed to take carnosine 2 times daily
Arm Title
stretching controls and supplementation with placebo
Arm Type
Experimental
Arm Description
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
Intervention Type
Behavioral
Intervention Name(s)
exercise
Intervention Description
participants will be subjected to 3 months supervised exercise intervention
Intervention Type
Dietary Supplement
Intervention Name(s)
carnosine supplementation
Intervention Description
participants will be instructed to take carnosine 2 times daily
Intervention Type
Behavioral
Intervention Name(s)
stretching
Intervention Description
participants will be subjected to 3 months supervised stretching program
Intervention Type
Dietary Supplement
Intervention Name(s)
supplementation with placebo
Intervention Description
participants will be instructed to take placebo 2 times daily
Primary Outcome Measure Information:
Title
glucose tolerance
Description
changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
Time Frame
up to 36 months
Title
learning/working memory
Description
exercise related changes in learning/working memory will be determined with the aid of Addenbrook's cognitive test (maximum test score 100)
Time Frame
up to 36 months
Title
motoric functions - Berg Balance Scale
Description
exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)
Time Frame
up to 36 months
Secondary Outcome Measure Information:
Title
habitual physical activity
Description
Habitual physical activity will be determined with accelerometers
Time Frame
up to 36 months
Title
physical fitness
Description
Submaximal aerobic capacity will be determined with one mile walk test
Time Frame
up to 36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
55 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Barbara Ukropcová, Assoc. Prof., MD, PhD
Phone
+421 2 32295 2261
Email
barbara.ukropcova@savba.sk
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Peter Turčáni, Prof., MD, PhD
Organizational Affiliation
University Hospital Bratislava, Comenius University, Bratislava,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Peter Valkovič, Prof., MD, PhD
Organizational Affiliation
University Hospital Bratislava, Comenius University, Bratislava,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Barbara Ukropcová, Assoc. Prof., MD, PhD
Organizational Affiliation
Biomedical Research Center, Slovak Academy of Sciences,
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Jozef Ukropec, DrSc, PhD
Organizational Affiliation
Biomedical Research Center, Slovak Academy of Sciences,
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Bratislava, Comenius University
City
Bratislava
ZIP/Postal Code
81369
Country
Slovakia
Individual Site Status
Active, not recruiting
Facility Name
Biomedical Research Center, Slovak Academy of Sciences
City
Bratislava
ZIP/Postal Code
84505
Country
Slovakia
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Barbara Ukropcová, Assoc. Prof., MD, PhD
Phone
+421 2 32295 2261
Email
barbara.ukropcova@savba.sk
First Name & Middle Initial & Last Name & Degree
Jozef Ukropec, DrSC., PhD
First Name & Middle Initial & Last Name & Degree
Lucia Slobodová, Mgr.
First Name & Middle Initial & Last Name & Degree
Martin Schon, MD
Facility Name
Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University
City
Tainan City
State/Province
Tainan
ZIP/Postal Code
701
Country
Taiwan
Individual Site Status
Active, not recruiting

12. IPD Sharing Statement

Plan to Share IPD
No

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

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