Effect of Gene Polymorphism on Cognitive Function

May 25, 2023 updated by: Dean-Chuan Wang, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital

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

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.

Study Overview

Status

Recruiting

Detailed 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.

Study Type

Observational

Enrollment (Estimated)

200

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

  • Name: Dean-Chuan Wang, PhD
  • Phone Number: 2737 +886-7-3121101
  • Email: dcw@kmu.edu.tw

Study Contact Backup

Study Locations

      • Kaohsiung, Taiwan, 807
        • Recruiting
        • Kaohsiung Medical University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Non-Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Serum BDNF levels
Time Frame: The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise 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
Change in Serum BDNF levels
Time Frame: The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise 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
Change in Serum Irisin Levels
Time Frame: The blood sample will be collected immediately after the participant has signed the consent to assess pre exercise 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
Change in Serum Irisin Levels
Time Frame: The blood sample will be collected 30 minutes after the participant has completed high intensity exercise to assess post exercise 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
Change in Stroop Reaction time
Time Frame: Baseline
Reaction time for Victorian version of Stroop test
Baseline
Change in Stroop Reaction time
Time Frame: Immediately after the procedure
Reaction time for Victorian version of Stroop test
Immediately after the procedure
Change in Fitlight reaction time
Time Frame: Baseline
Mean Reaction time to Fitlight Trainer complex patterns
Baseline
Change in Fitlight reaction time
Time Frame: Immediately after the procedure
Mean Reaction time to Fitlight Trainer complex patterns
Immediately after the procedure

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Monitor the Heart rate
Time Frame: During the procedure
Effect of gene polymorphism on changes in heart rate variability due to exercise.
During the procedure
Change in Fitlight simple reaction time
Time Frame: Baseline
Reaction time to Fitlight
Baseline
Change in Fitlight simple reaction time
Time Frame: Immediately after the procedure
Reaction time to Fitlight
Immediately after the procedure

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Dean-Chuan Wang, PhD, Kaohsiung Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 10, 2022

Primary Completion (Estimated)

July 1, 2024

Study Completion (Estimated)

July 1, 2024

Study Registration Dates

First Submitted

April 6, 2023

First Submitted That Met QC Criteria

May 25, 2023

First Posted (Actual)

May 30, 2023

Study Record Updates

Last Update Posted (Actual)

May 30, 2023

Last Update Submitted That Met QC Criteria

May 25, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Other Study ID Numbers

  • KMUHIRB-G(I)-20220005

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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