Ignite Creation Date:
2024-10-26 @ 3:37 PM
Last Modification Date:
2024-10-26 @ 3:37 PM
Study NCT ID:
NCT06547307
Status:
RECRUITING
Last Update Posted:
None
First Post:
2024-08-01
Brief Title:
CYP1A2 and ADORA2A Genotypes and Endurance Performance
Sponsor:
None
Organization:
None
Study Overview
Official Title:
Effects of Caffeine CYP1A2 and ADORA2A Genotypes on Cycling Endurance Performance
Status:
RECRUITING
Status Verified Date:
2024-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
No
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
The aim of this randomized double-blind placebo-controlled experiment will be to assess the potential effect of the selected gene polymorphism CYP1A2 ADORA2A on performance after caffeine ingestion
Detailed Description:
This randomized double-blinded placebo-controlled within-subjects counter-measured study design will include 60 males and females that fall between the given age range 18-35 years
Participants will complete five visits 90-120 min each 2 visits during the first week3 visit during week 2-4 in the Laboratory at Faculty of Sports Studies of Masaryk University All testing will take place Monday to Friday during morning hours 7-12 to minimize potential diurnal effect on sports performance Participants will be instructed to maintain their regular diet pre-testing meals will be replicated for all visits and sleeping habits avoid strenuous activity 48 hours before each visit and abstain from caffeine one week prior to the first visit and for the duration of the data collection 4 weeks
Sample size calculations We estimated sample size using GPower 31 Version 3194 Effect size 025 the trial would be powered to detect small but still physiologically important effect
Alpha error 0025 Power 1-Beta probability 08 Number of groups 6 - number of stratification required for genotype subgroup analysis number of measurements 3 Sample size based on calculation 60 participants are required
Recruitment
Recruitment will be carried out at Masaryk University by flyers Recruitment will also take place online through sharing on the website and social networks of the Faculty of Sports Studies of Masaryk University
Parameters of Assessment
Physiological data will be collected by a PhD-level exercise physiologist and two doctoral students
Height will be measured to the nearest 01 cm using a wall-mounted stadiometer and body weight will be measured to the nearest 01 kg using a digital scale with participants wearing light clothing without shoes
Body weight value will be measured on each visit and will be used to determine 2 and 4 mg per kilogram of body mass dosages for caffeine treatments plus a placebo dose that will be ingested in random order derived by research assistant and blinded to all investigators during visits 2 3 and 4 over the following three weeks
Body composition will be assessed by dual-energy x-ray absorptiometry DXA Horizon A Hologic Inc Marlborough MA during the first week of the study
Exercise Tests
VO2max test
Each participant will initially perform an incremental exercise test That test will assess Vo2max and maximal workload Wmax which is necessary for subsequent settings Respiratory parameters will be measured breath-by-breath using a CORTEX METALYZER 3B Wmax will be calculated using the following equation
Wmax Wfinal tT x Winc Where Wfinal is the power output of the final completed stage t is the time achieved in the final uncompleted stage s T is the duration of each stage s and Winc is the workload increment
Time trial
The ergometer will be set to linear mode workload increases as the pedalling rate increases Each participant will perform a warm-up at 1 Wkg for 5 minutes After the warm-up participants will be instructed to complete 10 km trial as quickly as possible with no temporal verbal or physiological feedback The primary variable measured will be the time to completion of the 10 km TT The ergometer will be set to linear mode using the following formula
W L x rpm2 where rpm is the pedalling rate and L is a linear factor dependent on the participants Wmax To ensure consistency across participants the resistance on the pedals during the TT will be set so that the participants would achieve 60 of their power output at 80 rpm using the following equation
L 060 x Wmax6400
A familiarization time trial will occur during the first week of a study
Rate of perceived exertion
During the time trial protocol information about the rate of perceived exertion will be collected Participants will be shown a Borgs scale of Perceived Exertion to assess the subjects fatigue This will be performed twice during the time trial protocol 5th and 9th km
Genotyping
Buccal mucosa smears will be collected during the first week of the study Investigators will examine known genetic variations CYP1a2 rs 762551 ADORA2A rs 5451876 that are associated with caffeine metabolism and response to determine if these genes affect response to exercise after subjects ingest caffeine
Caffeine intake questionnaire
Investigators will use a Caffeine intake questionnaire - revised CCQ-R to determine habitual caffeine intake in the week before the study starts and then each week to discover whether the participants comply with the restriction regarding caffeine or whether they have started consuming for example more chocolate
Training status
At the beginning of the study participants with one of the study investigators will complete Training and Performance Caliber A Participant Classification Framework based on the study by McKay et al 2021 to determine the training status of each individual
Statistical analysis
The statistical analysis will be carried out using IBM SPSS software Descriptive data will be reported VO2maxpeak body height body weight body fat lean body mass habitual caffeine intake training status A t-test will determine the comparison between genotypes Potential differences between 10 km TT will be assessed by an ANOVA with treatment as a within-participants factor and genotype as a between-participants factorif the distribution of the data will not be normal we will apply non-parametric equivalent of the test
Experimental procedure
Week 1
There will be three visits to the laboratories of the Faculty of Sports Studies at Masaryk University FSpS MU
i Participants will undergo body composition measurement DXA and a cheek swab for assessing selected gene variants Data about height weight and age will be collected Day 1 approximate duration of visit to FSpS MU 60-90 minutes
ii Participants will undergo maximal load testing using a cycling ergometer test and critical power testing using a cycling ergometer test Day 2 approximate duration of visit to FSpS MU 90 minutes
iii Participants will practice a 10-km time trial on the cycling ergometer Day 3 approximate duration of visit to FSpS MU 60 minutes
Weeks 2 3 4
Participants will undergo a 10-km time trial on the cycling ergometer After arrival participants will be randomly assigned to one of the three conditions They will always ingest same amount of the identical capsules with same colour size After 50 minutes after the capsule ingestion participants will start the warm-up and 60 minutes after the ingestion the TT will start This procedure will be identical for all experimental week 2 3 and 4 Participants may drink water ad libitum throughout the exercise test
Participants will complete five visits 90-120 min each 2 visits during the first week3 visit during week 2-4 in the Laboratory at Faculty of Sports Studies of Masaryk University All testing will take place Monday to Friday during morning hours 7-12 to minimize potential diurnal effect on sports performance Participants will be instructed to maintain their regular diet pre-testing meals will be replicated for all visits and sleeping habits avoid strenuous activity 48 hours before each visit and abstain from caffeine one week prior to the first visit and for the duration of the data collection 4 weeks
Sample size calculations We estimated sample size using GPower 31 Version 3194 Effect size 025 the trial would be powered to detect small but still physiologically important effect
Alpha error 0025 Power 1-Beta probability 08 Number of groups 6 - number of stratification required for genotype subgroup analysis number of measurements 3 Sample size based on calculation 60 participants are required
Recruitment
Recruitment will be carried out at Masaryk University by flyers Recruitment will also take place online through sharing on the website and social networks of the Faculty of Sports Studies of Masaryk University
Parameters of Assessment
Physiological data will be collected by a PhD-level exercise physiologist and two doctoral students
Height will be measured to the nearest 01 cm using a wall-mounted stadiometer and body weight will be measured to the nearest 01 kg using a digital scale with participants wearing light clothing without shoes
Body weight value will be measured on each visit and will be used to determine 2 and 4 mg per kilogram of body mass dosages for caffeine treatments plus a placebo dose that will be ingested in random order derived by research assistant and blinded to all investigators during visits 2 3 and 4 over the following three weeks
Body composition will be assessed by dual-energy x-ray absorptiometry DXA Horizon A Hologic Inc Marlborough MA during the first week of the study
Exercise Tests
VO2max test
Each participant will initially perform an incremental exercise test That test will assess Vo2max and maximal workload Wmax which is necessary for subsequent settings Respiratory parameters will be measured breath-by-breath using a CORTEX METALYZER 3B Wmax will be calculated using the following equation
Wmax Wfinal tT x Winc Where Wfinal is the power output of the final completed stage t is the time achieved in the final uncompleted stage s T is the duration of each stage s and Winc is the workload increment
Time trial
The ergometer will be set to linear mode workload increases as the pedalling rate increases Each participant will perform a warm-up at 1 Wkg for 5 minutes After the warm-up participants will be instructed to complete 10 km trial as quickly as possible with no temporal verbal or physiological feedback The primary variable measured will be the time to completion of the 10 km TT The ergometer will be set to linear mode using the following formula
W L x rpm2 where rpm is the pedalling rate and L is a linear factor dependent on the participants Wmax To ensure consistency across participants the resistance on the pedals during the TT will be set so that the participants would achieve 60 of their power output at 80 rpm using the following equation
L 060 x Wmax6400
A familiarization time trial will occur during the first week of a study
Rate of perceived exertion
During the time trial protocol information about the rate of perceived exertion will be collected Participants will be shown a Borgs scale of Perceived Exertion to assess the subjects fatigue This will be performed twice during the time trial protocol 5th and 9th km
Genotyping
Buccal mucosa smears will be collected during the first week of the study Investigators will examine known genetic variations CYP1a2 rs 762551 ADORA2A rs 5451876 that are associated with caffeine metabolism and response to determine if these genes affect response to exercise after subjects ingest caffeine
Caffeine intake questionnaire
Investigators will use a Caffeine intake questionnaire - revised CCQ-R to determine habitual caffeine intake in the week before the study starts and then each week to discover whether the participants comply with the restriction regarding caffeine or whether they have started consuming for example more chocolate
Training status
At the beginning of the study participants with one of the study investigators will complete Training and Performance Caliber A Participant Classification Framework based on the study by McKay et al 2021 to determine the training status of each individual
Statistical analysis
The statistical analysis will be carried out using IBM SPSS software Descriptive data will be reported VO2maxpeak body height body weight body fat lean body mass habitual caffeine intake training status A t-test will determine the comparison between genotypes Potential differences between 10 km TT will be assessed by an ANOVA with treatment as a within-participants factor and genotype as a between-participants factorif the distribution of the data will not be normal we will apply non-parametric equivalent of the test
Experimental procedure
Week 1
There will be three visits to the laboratories of the Faculty of Sports Studies at Masaryk University FSpS MU
i Participants will undergo body composition measurement DXA and a cheek swab for assessing selected gene variants Data about height weight and age will be collected Day 1 approximate duration of visit to FSpS MU 60-90 minutes
ii Participants will undergo maximal load testing using a cycling ergometer test and critical power testing using a cycling ergometer test Day 2 approximate duration of visit to FSpS MU 90 minutes
iii Participants will practice a 10-km time trial on the cycling ergometer Day 3 approximate duration of visit to FSpS MU 60 minutes
Weeks 2 3 4
Participants will undergo a 10-km time trial on the cycling ergometer After arrival participants will be randomly assigned to one of the three conditions They will always ingest same amount of the identical capsules with same colour size After 50 minutes after the capsule ingestion participants will start the warm-up and 60 minutes after the ingestion the TT will start This procedure will be identical for all experimental week 2 3 and 4 Participants may drink water ad libitum throughout the exercise test
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None