PolymorphosisNCT05879341
Effect of Gene Polymorphism on Cognitive Function
An observational study of Polymorphosis and Cognitive Function, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
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… Read more about this study
- Who is it for?
- Ages 20 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Polymorphosis, Cognitive Function
- What is being tested?
- High intensitiy interval training
- How many people
- 200 participants
- Where
- 1 siteTaiwan
- Study dates
- 10 Jun 2022to Jul 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Taiwanese National who perform less than 120 minutes of aerobic exercise per week.
Who may be able to join
- 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
Who cannot join
- Subjects who are diagnosed with
- Hypertension
- Arrhythmia
- Depression
- Color blindness
- Musculoskeletal injury within one year
- Body Mass index higher than 25
- Pregnant females
Trial locations and contacts
1 site in 1 country.
Taiwan1 site, 1 recruiting
- Recruiting
Kaohsiung Medical University
Kaohsiung City, 807
About this study
Official title: 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.
Read more
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.
Read the 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.
- Conditions
- Polymorphosis, Cognitive Function
- Being tested
- High intensitiy interval training
- Keywords
- Irisin, Cognition, Polymorphism, High intensity interval training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High intensitiy interval trainingOther
Also called HIIT, High intensity interval Exercise
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Serum BDNF levels
Serum brain derived neurotrophic factor levels
Measured: 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
Serum brain derived neurotrophic factor levels
Measured: 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
Serum Irisin levels
Measured: 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
Serum Irisin levels
Measured: 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
Reaction time for Victorian version of Stroop test
Measured: Baseline
Change in Stroop Reaction time
Reaction time for Victorian version of Stroop test
Measured: Immediately after the procedure
Change in Fitlight reaction time
Mean Reaction time to Fitlight Trainer complex patterns
Measured: Baseline
Change in Fitlight reaction time
Mean Reaction time to Fitlight Trainer complex patterns
Measured: Immediately after the procedure
Secondary outcomes (3)
Monitor the Heart rate
Effect of gene polymorphism on changes in heart rate variability due to exercise.
Measured: During the procedure
Change in Fitlight simple reaction time
Reaction time to Fitlight
Measured: Baseline
Change in Fitlight simple reaction time
Reaction time to Fitlight
Measured: Immediately after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2023
- Study start10 Jun 2022
- Primary completionJul 2024 (estimated)
- Study completionJul 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PolymorphosisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Responsible party
- Principal investigator, Dean-Chuan Wang, PhD, Kaohsiung Medical University Chung-Ho Memorial Hospital
- Investigators
- Dean-Chuan Wang, PhD, Principal investigator, Kaohsiung Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05879341
- Sponsor's protocol ID
- KMUHIRB-G(I)-20220005
- Status last verified
- May 2023
- First submitted
- 6 Apr 2023
- Last updated
- 30 May 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 May 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Irisin Polymorphism on Cognitive Function and Inter-individual Exercise Response Variability
- ClinicalTrials.gov ID
- NCT05879341
- Acronym / sponsor ID
- KMUHIRB-G(I)-20220005
- Conditions
- Polymorphosis, Cognitive Function
- Keywords
- Irisin, Cognition, Polymorphism, High intensity interval training
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Kaohsiung Medical University Chung-Ho Memorial HospitalUniversity, hospital or other
- Collaborators
- Ministry of Science and Technology, Taiwan
- Study start
- 10 Jun 2022 (actual)
- Primary completion
- Jul 2024 (estimated)
- Study completion
- Jul 2024 (estimated)
- First posted
- 30 May 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Ecologic or community
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 20 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Taiwanese National who perform less than 120 minutes of aerobic exercise per week.
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- Subjects who are diagnosed with
- Hypertension
- Arrhythmia
- Depression
- Color blindness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| High intensitiy interval trainingAlso: HIIT, High intensity interval ExerciseThe 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. | Other | – |
Primary outcome
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
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
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
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
Change in Stroop Reaction time
Time frame: Baseline
Reaction time for Victorian version of Stroop test
Change in Stroop Reaction time
Time frame: Immediately after the procedure
Reaction time for Victorian version of Stroop test
Change in Fitlight reaction time
Time frame: Baseline
Mean Reaction time to Fitlight Trainer complex patterns
Change in Fitlight reaction time
Time frame: Immediately after the procedure
Mean Reaction time to Fitlight Trainer complex patterns
3 secondary outcomes
Monitor the Heart rate
Time frame: During the procedure
Change in Fitlight simple reaction time
Time frame: Baseline
Change in Fitlight simple reaction time
Time frame: Immediately after the procedure
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 May 2023.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dean-Chuan Wang, PhD principal investigator
Kaohsiung Medical University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Polymorphosis and Cognitive Function, run by Kaohsiung Medical University Chung-Ho Memorial Hospital at 1 site in Taiwan.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 May 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Taiwan. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Dean-Chuan Wang, PhD (+886-7-3121101 ext. 2737, dcw@kmu.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 May 2023.