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

Not Applicable

• Conditions: Subjective Cognitive Impairment; Mild Cognitive Impairment; Parkinson Disease; Healthy Volunteers
• Interventions: Behavioral: exercise; Dietary Supplement: carnosine supplementation; Behavioral: stretching; Dietary Supplement: supplementation with placebo

• Registration Number: NCT03330470
• Lead Sponsor: Slovak Academy of Sciences

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 Timeline

• Study Start: 2017-01-01
• Status Verified: 2017-10
• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-30
• Study First Posted: 2017-11-06
• Last Update Submitted: 2018-09-13
• Last Update Posted: 2018-09-17
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 100

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
exercise and carnosine supplementation	exercise	exercise: participants will be subjected to 3 months supervised exercise intervention carnosine supplementation: participants will be instructed to take carnosine 2 times daily
exercise and carnosine supplementation	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
stretching controls and carnosine supplementation	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
stretching controls and carnosine supplementation	stretching	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 and supplementation with placebo	stretching	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
stretching controls and supplementation with placebo	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
exercise and supplementation with placebo	exercise	exercise: participants will be subjected to 3 months supervised exercise intervention supplementation with placebo: participants will be instructed to take placebo 2 times daily
exercise and supplementation with placebo	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

Primary Outcome Measures

Name	Time	Method
learning/working memory	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)
glucose tolerance	up to 36 months	changes in glucose tolerance will be determined with oral glucose tolerance test (2h glucose, mmol/l)
motoric functions - Berg Balance Scale	up to 36 months	exercise related changes in motoric functions will be determined with the aid of Berg Balance Scale (maximum score 56)

Secondary Outcome Measures

Name	Time	Method
physical fitness	up to 36 months	Submaximal aerobic capacity will be determined with one mile walk test
habitual physical activity	up to 36 months	Habitual physical activity will be determined with accelerometers

Trial Locations

Locations (3)

Biomedical Research Center, Slovak Academy of Sciences; 🇸🇰 Bratislava, Slovakia

University Hospital Bratislava, Comenius University; 🇸🇰 Bratislava, Slovakia

Laboratory of Cognitive Neurophysiology, Institute of Physical Education, Health & Leisure Studies, National Cheng Kung University; 🇨🇳 Tainan City, Tainan, Taiwan