Effect of Gene Polymorphism on Cognitive Function

Cognitive Function Clinical Trial

Official title:

The Effect of Irisin Polymorphism on Cognitive Function and Inter-individual Exercise Response Variability

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05879341
• Other study ID #: KMUHIRB-G(I)-20220005
• Status: Recruiting
• Start date: June 10, 2022
• Est. completion date: July 2024

Study information

• Verified date: May 2023
• Source: Kaohsiung Medical University Chung-Ho Memorial Hospital
• Contact: Dean-Chuan Wang, PhD
• Phone: +886-7-3121101
• Email: dcw[@]kmu.edu.tw
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The goal of this observational study is to study the effect of gene polymorphism on cognitive improvement in response to exercise in healthy participants. The main questions it aims to answer are:

To investigate whether FNDC5/Irisin genotype polymorphism affects cognitive function and inter-individual variability in exercise response.

To explore whether the FNDC5/Irisin gene polymorphism can act alone or interact with the BDNF gene to cause inter-individual differences in cognitive function responses to exercise gain.

Participants will be asked to perform high-intensity interval training( HIIT) on a cycle ergometer. Each high-intensity training period will be 30 seconds followed by a 4-minute rest period.

The participants will also perform cognitive tests (Vistorian stroop test and Fitlight trainer test) before and after the exercise.

Description:

Exercise has a significant effect on improving brain function. It can improve cognitive function, enhance learning effects, and prevent the occurrence of neurodegenerative diseases in the elderly. Exercise's mechanism of action to improve cognitive function includes stimulating the nervous system to secrete brain-derived neurotrophic factor (BDNF) and skeletal muscle to secrete irisin. However, the effect of exercise on improving physical function varies from person to person. This phenomenon is called inter-individual exercise response variability. Genetic differences may be responsible for this phenomenon. The genotype differences of BDNF and Irisin can cause cognitive function. However, the scientific community is still unclear whether the differences between the two genotypes are related to individual differences in exercise responses. The investigators suspect that genotype might be responsible for interindividual variability in motor responses and therefore designed this experiment to test this thesis. This study is expected to recruit 200 healthy adults to complete the genotype sequencing of BDNF and Irisin and use the cognitive function responses before and after a single high-intensity interval aerobic exercise to establish the model that genotype affects the variability of individual exercise responses. The experimental results of this study can help the scientific community understand the influence of genotype on individual differences in exercise response and further explore and refine the design of exercise prescription.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 200
• Est. completion date: July 2024
• Est. primary completion date: July 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 20 Years to 40 Years

Eligibility

Inclusion Criteria:

• Taiwanese National who perform less than 120 minutes of aerobic exercise per week.

The subjects will refrain from drinking alcoholic or caffeinated drinks 24 hours prior to the participation in the study

Exclusion Criteria:

Subjects who are diagnosed with

• Hypertension

• Arrhythmia

• Depression

• Color blindness

• Musculoskeletal injury within one year

Body Mass index higher than 25

Pregnant females

Related Conditions & MeSH terms

• Cognitive Function
• Polymorphosis

Intervention

Other:
• High intensitiy interval training
The participants will perform HIIT at 85% of their heart rate reserve. There will be 8 cycles of high intensity with four minutes of rest intervals in between.

Locations

Country	Name	City	State
Taiwan	Kaohsiung Medical University	Kaohsiung

Sponsors (2)

Lead Sponsor	Collaborator
Kaohsiung Medical University Chung-Ho Memorial Hospital	Ministry of Science and Technology, Taiwan

Country where clinical trial is conducted

Taiwan, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Serum BDNF levels	Serum brain derived neurotrophic factor levels	The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise BDNF levels
Primary	Change in Serum BDNF levels	Serum brain derived neurotrophic factor levels	The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise BDNF levels
Primary	Change in Serum Irisin Levels	Serum Irisin levels	The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise Irisin levels
Primary	Change in Serum Irisin Levels	Serum Irisin levels	The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise Irisin levels
Primary	Change in Stroop Reaction time	Reaction time for Victorian version of Stroop test	Baseline
Primary	Change in Stroop Reaction time	Reaction time for Victorian version of Stroop test	Immediately after the procedure
Primary	Change in Fitlight reaction time	Mean Reaction time to Fitlight Trainer complex patterns	Baseline
Primary	Change in Fitlight reaction time	Mean Reaction time to Fitlight Trainer complex patterns	Immediately after the procedure
Secondary	Monitor the Heart rate	Effect of gene polymorphism on changes in heart rate variability due to exercise.	During the procedure
Secondary	Change in Fitlight simple reaction time	Reaction time to Fitlight	Baseline
Secondary	Change in Fitlight simple reaction time	Reaction time to Fitlight	Immediately after the procedure