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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

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

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

NCT ID

NCT03330470

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

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

Studies a U.S. FDA-regulated Device Product

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

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

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

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

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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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