Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03330470
Recruitment Status : Recruiting
First Posted : November 6, 2017
Last Update Posted : September 17, 2018
Sponsor:
Collaborators:
Comenius University
University Hospital Bratislava
National Cheng Kung University
Information provided by (Responsible Party):
Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences

Tracking Information
First Submitted Date  ICMJE October 17, 2017
First Posted Date  ICMJE November 6, 2017
Last Update Posted Date September 17, 2018
Actual Study Start Date  ICMJE January 1, 2017
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • glucose tolerance [ Time Frame: up to 36 months ]
    changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
  • learning/working memory [ Time Frame: up to 36 months ]
    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 [ Time Frame: up to 36 months ]
    exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)
Original Primary Outcome Measures  ICMJE Same as current
Change History Complete list of historical versions of study NCT03330470 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: October 30, 2017)
  • habitual physical activity [ Time Frame: up to 36 months ]
    Habitual physical activity will be determined with accelerometers
  • physical fitness [ Time Frame: up to 36 months ]
    Submaximal aerobic capacity will be determined with one mile walk test
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
Official Title  ICMJE Molecular Mediators of Physical Exercise and Carnosine Induced Effects in Patients With Preclinical and Early Stage Neurodegenerative Disease
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.

Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE
  • Subjective Cognitive Impairment
  • Mild Cognitive Impairment
  • Parkinson Disease
  • Healthy Volunteers
Intervention  ICMJE
  • 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
  • Behavioral: stretching
    participants will be subjected to 3 months supervised stretching program
  • Dietary Supplement: supplementation with placebo
    participants will be instructed to take placebo 2 times daily
Study Arms  ICMJE
  • 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
    Interventions:
    • Behavioral: exercise
    • Dietary Supplement: carnosine supplementation
  • 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
    Interventions:
    • Behavioral: exercise
    • Dietary Supplement: supplementation with placebo
  • 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
    Interventions:
    • Dietary Supplement: carnosine supplementation
    • Behavioral: stretching
  • 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
    Interventions:
    • Behavioral: stretching
    • Dietary Supplement: supplementation with placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: October 30, 2017)
100
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 55 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE
Contact: Barbara Ukropcová, Assoc. Prof., MD, PhD +421 2 32295 2261 barbara.ukropcova@savba.sk
Listed Location Countries  ICMJE Slovakia,   Taiwan
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT03330470
Other Study ID Numbers  ICMJE 15-0253
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: No
Responsible Party Barbara Ukropcová, MD, PhD, Slovak Academy of Sciences
Study Sponsor  ICMJE Slovak Academy of Sciences
Collaborators  ICMJE
  • Comenius University
  • University Hospital Bratislava
  • National Cheng Kung University
Investigators  ICMJE
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,
PRS Account Slovak Academy of Sciences
Verification Date October 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP