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

Healthy Volunteers Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03330470
• Other study ID #: 15-0253
• Status: Recruiting
• Phase: N/A
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: October 2017
• Source: Slovak Academy of Sciences
• Contact: Barbara Ukropcová, Assoc. Prof., MD, PhD
• Phone: +421 2 32295 2261
• Email: barbara.ukropcova[@]savba.sk
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 55 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Cognitive Dysfunction
• Healthy Volunteers
• Mild Cognitive Impairment
• Neurodegenerative Diseases
• Parkinson Disease
• Subjective Cognitive Impairment

Intervention

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

Locations

Country	Name	City	State
Slovakia	Biomedical Research Center, Slovak Academy of Sciences	Bratislava
Slovakia	University Hospital Bratislava, Comenius University	Bratislava
Taiwan	Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University	Tainan City	Tainan

Sponsors (4)

Lead Sponsor	Collaborator
Slovak Academy of Sciences	Comenius University, National Cheng Kung University, University Hospital Bratislava

Countries where clinical trial is conducted

Slovakia,  Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	glucose tolerance	changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)	up to 36 months
Primary	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
Primary	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	habitual physical activity	Habitual physical activity will be determined with accelerometers	up to 36 months
Secondary	physical fitness	Submaximal aerobic capacity will be determined with one mile walk test	up to 36 months