Exercise TrainingPreExNCT05874986
Why do People Respond Differently to Resistance Training?
A study testing Resistance training in people with Exercise Training and Healthy, run by University of Jyvaskyla at 1 site in Finland.
Trial summary
It is well known that regular resistance training (RT) can have health benefits. However, considerable heterogeneity in RT responses has been observed. The mechanisms underlying an individual's ability to respond to RT are mainly unknown but involve a complex network of genomic and non-genomic factors. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Exercise Training, Healthy, Skeletal Muscle Hypertrophy
- What is being tested?
- Resistance training
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 393 participants
- Where
- 1 siteFinland
- Study dates
- 22 Feb 2023to 21 Aug 2024
- Phase
- Interventional
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- age 18-50
- healthy (e.g., no diagnosed type 2 diabetes, cardiovascular disease, musculoskeletal disorders, etc.)
- limited experience in resistance training
Who cannot join
- medication affecting the cardiovascular system or metabolism
- metabolic, musculoskeletal, cardiovascular, or other diseases or disorders which may preclude the ability to perform exercise training and testing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Precision Exercise (PreEx): Identifying the Determinants of Inter-individual Variation in Resistance Training Responses
It is well known that regular resistance training (RT) can have health benefits. However, considerable heterogeneity in RT responses has been observed. The mechanisms underlying an individual's ability to respond to RT are mainly unknown but involve a complex network of genomic and non-genomic factors. The investigators aim to examine heterogeneity in physiological responses to RT while closely monitoring other environmental factors (e.g., physical activity levels, nutrition, sleep, and stress). Participants are healthy sedentary males and females aged 18-50 (n=400). A controlled 12-week RT intervention will be conducted in two separate data collection periods due to our sample size to characterize RT response. Data will be collected before, during, and after the study period by using measurements of muscle size, physical fitness characteristics, and body composition, as well as by collecting blood samples and questionnaires. The investigators will identify the underlying factors contributing to why people differ in their physiological responses to RT. For this, comprehensive background data will be collected to identify common denominators underlying individual differences in response to RT. The investigators will use sophisticated analytical methods to reveal new predictors of training response for different traits. This research project aims to gain insight into the sources of individual variation in physiological responses to RT. On this basis, exercise training can be personalized to optimize the benefits of RT for all individuals. Ultimately, the investigators will also be able to justify better using RT as part of individualized healthcare strategies in the future.
Read the detailed description
The benefits of regular resistance training (RT) are well acknowledged, but it is also well known that tremendous inter-individual variability can be detected in responses to RT. The reason(s) for individual variations in responses to RT is a very complex physiological phenomenon and is still poorly known. The individual variation in trainability suggests genetic diversity, but also non-genetic determinants potentially contribute significantly to RT responses.
The investigators hypothesize that in this study, a broad spectrum of adaptive responses to RT is detected. By scrutinizing participants' backgrounds, it can be elucidated why individuals respond differently to regular RT. Furthermore, it is hypothesized that the investigators can identify specific predictive markers for RT responsiveness. That is possible by combining information on training responsiveness with the personal characteristics of the participant.
Healthy young adults aged 18-50 will be recruited to the study in two periods to understand the biological basis of heterogeneity in RT responses by minimizing potential age and health-related physiological confounders. They are premised to respond positively to the study's primary outcome, which is the cross-sectional area (CSA) of the m. vastus lateralis (VL). To collect comprehensive data, the number of participants is maximized within the practical limitations based on our previous and extensive RT studies. Therefore, of the 400 recruited participants, 240 will first undergo 12 weeks of RT (data collection I), after which 160 participants will perform an RT period with a similar design (data collection II). Thus, an RT period will be conducted in two separate periods for both of these subsamples, as 240 is the maximum number of participants that can be supervised with our comprehensive and time-consuming physiological measures within the allocated data collection timeframe. Participants comprise an equal proportion of males and females, and sex differences in RT responsiveness will be investigated as a secondary aim of the study. Combined, data collection I and II are referred to as intervention I.
The study design of the data collection I is a single-arm trial (ethical statement number 60/13.00.04.00/2023). After assessing eligibility, participants engage in the baseline measurements and the 12-week fully supervised RT intervention. Additionally, we employ a randomized dual-trial design in data collection II (ethical statement number 1394/13.00.04.00/2023) in which one arm performs a non-RT control period before an RT period, whilst the other arm only performs RT. Moreover, test-retest baseline measurements will be performed in data collection II. The RT protocol is similar for both data collections. The participants will train two times a week, and the program will target all major muscle groups. Each training session includes exercises for the lower (leg press, knee extension) and upper body (bench press, biceps curl, and seated row). The participants will perform ~10 repetitions per set (approximately 60-80% of 1RM, 8-12 RM zone) and three working sets per exercise. The last set of each exercise is performed to momentary failure in each session. Loads are increased progressively in each exercise, session to session, during the RT period using double progression based on the final set of each exercise. A questionnaire on perceived exertion after each exercise session (sRPE) will be obtained to evaluate the participant's intrinsic effort in performing exercises. The training is executed in a local university gym with a standardized time of day, and training diaries are used to track the training loads.
The measurements are obtained at baseline and after the intervention in data collection I. Furthermore, mid-measurements are also performed in data collection II. Participants are informed of the study goals and are carefully familiarized with study protocols. All the tests are carried out at the same time of day. The participants are given feedback on their test results during the project. In addition to genetics, environmental factors are essential in explaining individuality in training responses. In this project, the investigators focus on gathering comprehensive data on variables of participants' background, nutrition, health status, and physical activity that can potentially influence the heterogeneity of RT adaptations.
- Conditions
- Exercise Training, Healthy, Skeletal Muscle Hypertrophy
- Being tested
- Resistance training
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Resistance trainingOther
Also called Exercise training
12-week resistance training intervention
| Study group | Role | What they receive |
|---|---|---|
| Training group (n=362) | Other | All the participants from data collection I and data collection II. Receives: Other: Resistance training |
| Control group (n=75) | Other | The control group consists of the participants from the training group who undergo a control period before the intervention. Receives: Other: Resistance training |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in m. vastus lateralis (VL) cross-sectional area (CSA) after 6 and 12-week resistance training
VL CSA (cm^2) is determined at mid-thigh using a B-mode axial plane ultrasound (model SSD-α10, Aloka, Tokyo, Japan) with a 13 MHz linear-array probe (60 mm width) in extended-field-of-view mode (23 Hz sampling frequency).
However, since Aloka US began to show signs of malfunctioning before the onset of data collection II (approximately four months after the end of data collection I), another US device (Venue Fit R4, GE Medical Systems, USA) was used in data collection II. Due to this US-device change, test-retest measurements at baseline were performed with both devices in data collection II to enable statistical comparison of these devices later.
GE-US was used with a L4-20t-RS linear-array probe (48,43 mm width) in extended-field-of-view mode (6/12 MHz, 39 frames per second).
Measured: Baseline (test and retest), week 7, week 13
Secondary outcomes (16)
Change in lower limb maximal strength after 6 and 12-week resistance training
Maximal voluntary concentric muscle strength of leg extensors (kg) is determined in horizontal leg press device (David 210) via one-repetition maximum (1RM) test according to the NCSA guidelines. 1RM is determined with an accuracy of 2.5 kilograms.
Measured: Baseline (test and retest), week 7, week 13
Change in whole-body volume (cm^3) after 6 and 12-weeks of resistance training
The 3D optical body (3DO) scan is used to measure whole-body volume, the volume of the body segments, and waist, hip, and thigh circumference. For 3DO, Fit3D ProScanner (Redwood City, CA, USA) is used.
Measured: Baseline (test and retest), week 7, week 13
Change in whole body fat-free mass after 6 and 12-week resistance training
Fat-free body mass (kg) is measured at morning after overnight fasting by bioimpedance device (InBody 770, Biospace Co. Seoul, Korea)
Measured: Baseline (test and retest), week 7, week 13
Change in whole body fat mass after 6 and 12-week resistance training
Fat body mass (kg) is measured at morning after overnight fasting by bioimpedance device (InBody 770, Biospace Co. Seoul, Korea)
Measured: Baseline (test and retest), week 7, week 13
Change in waist circumference after 6 and 12-week resistance training
Waist circumference is measured by measuring tape horizontally around the waist above hipbones after exhaling in standing position
Measured: Baseline (test and retest), week 7, week 13
Change in grip strength after 6 and 12-week resistance training
The maximal isometric grip strength is measured on dominant side at 90 degree elbow angle in a sitting position using a dynamometer chair (Good Strength, Metitur, Palokka, Finland)
Measured: Baseline (test and retest), week 7, week 13
Change in maximal vertical jump height after 6 and 12-week resistance training
The countermovement jump height is calculated by measurement of flight time by jump mat
Measured: Baseline (test and retest), week 7, week 13
Change in blood count determined from the venous blood sample obtained at morning after overnight fasting before, and after 12-week resistance training
Full blood count is measured by hematology analyzer (Sysmex KX-21N, Sysmex Corp., Japan)
Measured: Baseline, week 13
Change in C-reactive protein (CRP) determined from the venous blood sample obtained at morning after overnight fasting before and after 12-week resistance training
Serum CRP is measured by high-sensitivity ELISA kit (Quantikine HS, R\&D Systems, Minneapolis, USA).
Measured: Baseline, week 13
Change in metabolomics determined from the venous blood sample obtained at morning after overnight fasting before and after 12-week resistance training
A high-throughput serum Nuclear Magnetic Resonance (NMR) metabolomics platform will be used for the absolute quantification of serum lipids and metabolite profile.
Measured: Baseline, week 13
Self-reported measure of physical activity
Investigated by the Global Physical Activity Questionnaire (GPAQ), a standardized 16-question questionnaire that assesses categories of low, moderate, and vigorous physical activity (in MET minutes per week) in three different domains: activity at work, travel to and from places, and leisure activities. Also, sedentary behavior (minutes per week) is assessed.
Measured: Baseline and after 12-weeks of RT
Sleep self-assessment
Investigated by The Pittsburgh Sleep Quality Index (PSQI) questionnaire which consists of questions of a four-point Likert scale (0-3), with higher scores representing greater sleep difficulties.
Measured: Baseline and after 12-weeks of RT
Self-report of eating disorder behaviors and attitudes
Investigated by the Eating Disorder Examination Questionnaire (EDE-Q), which assesses the extent, frequency, and severity of eating disorder-related behaviors on a seven-point Likert scale or occurrence over a 28-day period. Higher scores represent higher levels of eating disorders.
Measured: Baseline and after 12-weeks of RT
Self-estimated dietary intake
Investigated by a food frequency questionnaire (FFQ) which consists of a finite list of foods and beverages with response categories to indicate usual frequency of consumption over the time period queried.
Measured: Baseline and after 12-weeks of RT
Self-estimated energy availability
Investigated by the Low Energy Availability Questionnaire (LEAF-Q for females, LEAM-Q for men) which identifies persons at risk for low energy availability by utilizing subsets of gastrointestinal symptoms, injury frequency, and menstrual dysfunction (in women). A score ≥8 indicates that an individual is at risk for low energy availability.
Measured: Baseline and after 12-weeks of RT
Self-measure of perceived stress
Investigated by Perceived Stress Scale (14 items); from 0 (never) to 4 (very often)
Measured: Baseline and after 12-weeks of RT
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 May 2023
- Study start22 Feb 2023
- Primary completion21 Aug 2024
- Study completion21 Aug 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Exercise TrainingStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 393 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jyvaskyla
- Sponsor type
- University, hospital or other
- Collaborators
- Academy of Finland
- Responsible party
- Principal investigator, Juha Ahtiainen, University of Jyvaskyla
- Investigators
- Juha P Ahtiainen, Assoc.Prof., Principal investigator, University of Jyväskylä, Faculty of Sport and Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05874986
- Sponsor's protocol ID
- 60/13.00.04.00/2023
- Acronym
- PreEx
- Status last verified
- Apr 2025
- First submitted
- 23 Feb 2023
- Last updated
- 16 Apr 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All of the individual participant data collected during the trial, after deidentification.
Study at a glance
From the registry record, last updated by the sponsor on 16 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Precision Exercise (PreEx): Identifying the Determinants of Inter-individual Variation in Resistance Training Responses
- ClinicalTrials.gov ID
- NCT05874986
- Acronym / sponsor ID
- PreEx / 60/13.00.04.00/2023
- Conditions
- Exercise Training, Healthy, Skeletal Muscle Hypertrophy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 393 participants (actual)
- Lead sponsor
- University of JyvaskylaUniversity, hospital or other
- Collaborators
- Academy of Finland
- Study start
- 22 Feb 2023 (actual)
- Primary completion
- 21 Aug 2024 (actual)
- Study completion
- 21 Aug 2024 (actual)
- First posted
- 25 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.
It is well known that regular resistance training (RT) can have health benefits. However, considerable heterogeneity in RT responses has been observed. The mechanisms underlying an individual's ability to respond to RT are mainly unknown but involve a complex network of genomic and non-genomic factors. The investigators aim to examine heterogeneity in physiological responses to RT while closely monitoring other environmental factors (e.g., physical activity levels, nutrition, sleep, and stress). Participants are healthy sedentary males and females aged 18-50 (n=400). A controlled 12-week RT intervention will be conducted in two separate data collection periods due to our sample size to characterize RT response. Data will be collected before, during, and after the study period by using measurements of muscle size, physical fitness characteristics, and body composition, as well as by collecting blood samples and questionnaires. The investigators will identify the underlying factors contributing to why people differ in their physiological responses to RT. For this, comprehensive background data will be collected to identify common denominators underlying individual differences in response to RT. The investigators will use sophisticated analytical methods to reveal new predictors of training response for different traits. This research project aims to gain insight into the sources of individual variation in physiological responses to RT. On this basis, exercise training can be personalized to optimize the benefits of RT for all individuals. Ultimately, the investigators will also be able to justify better using RT as part of individualized healthcare strategies in the future.
Detailed description
The benefits of regular resistance training (RT) are well acknowledged, but it is also well known that tremendous inter-individual variability can be detected in responses to RT. The reason(s) for individual variations in responses to RT is a very complex physiological phenomenon and is still poorly known. The individual variation in trainability suggests genetic diversity, but also non-genetic determinants potentially contribute significantly to RT responses.
The investigators hypothesize that in this study, a broad spectrum of adaptive responses to RT is detected. By scrutinizing participants' backgrounds, it can be elucidated why individuals respond differently to regular RT. Furthermore, it is hypothesized that the investigators can identify specific predictive markers for RT responsiveness. That is possible by combining information on training responsiveness with the personal characteristics of the participant.
Healthy young adults aged 18-50 will be recruited to the study in two periods to understand the biological basis of heterogeneity in RT responses by minimizing potential age and health-related physiological confounders. They are premised to respond positively to the study's primary outcome, which is the cross-sectional area (CSA) of the m. vastus lateralis (VL). To collect comprehensive data, the number of participants is maximized within the practical limitations based on our previous and extensive RT studies. Therefore, of the 400 recruited participants, 240 will first undergo 12 weeks of RT (data collection I), after which 160 participants will perform an RT period with a similar design (data collection II). Thus, an RT period will be conducted in two separate periods for both of these subsamples, as 240 is the maximum number of participants that can be supervised with our comprehensive and time-consuming physiological measures within the allocated data collection timeframe. Participants comprise an equal proportion of males and females, and sex differences in RT responsiveness will be investigated as a secondary aim of the study. Combined, data collection I and II are referred to as intervention I.
The study design of the data collection I is a single-arm trial (ethical statement number 60/13.00.04.00/2023). After assessing eligibility, participants engage in the baseline measurements and the 12-week fully supervised RT intervention. Additionally, we employ a randomized dual-trial design in data collection II (ethical statement number 1394/13.00.04.00/2023) in which one arm performs a non-RT control period before an RT period, whilst the other arm only performs RT. Moreover, test-retest baseline measurements will be performed in data collection II. The RT protocol is similar for both data collections. The participants will train two times a week, and the program will target all major muscle groups. Each training session includes exercises for the lower (leg press, knee extension) and upper body (bench press, biceps curl, and seated row). The participants will perform ~10 repetitions per set (approximately 60-80% of 1RM, 8-12 RM zone) and three working sets per exercise. The last set of each exercise is performed to momentary failure in each session. Loads are increased progressively in each exercise, session to session, during the RT period using double progression based on the final set of each exercise. A questionnaire on perceived exertion after each exercise session (sRPE) will be obtained to evaluate the participant's intrinsic effort in performing exercises. The training is executed in a local university gym with a standardized time of day, and training diaries are used to track the training loads.
The measurements are obtained at baseline and after the intervention in data collection I. Furthermore, mid-measurements are also performed in data collection II. Participants are informed of the study goals and are carefully familiarized with study protocols. All the tests are carried out at the same time of day. The participants are given feedback on their test results during the project. In addition to genetics, environmental factors are essential in explaining individuality in training responses. In this project, the investigators focus on gathering comprehensive data on variables of participants' background, nutrition, health status, and physical activity that can potentially influence the heterogeneity of RT adaptations.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Training group (n=362) | Other | Other: Resistance trainingAll the participants from data collection I and data collection II. |
| Control group (n=75) | Other | Other: Resistance trainingThe control group consists of the participants from the training group who undergo a control period before the intervention. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- age 18-50
- healthy (e.g., no diagnosed type 2 diabetes, cardiovascular disease, musculoskeletal disorders, etc.)
- limited experience in resistance training
Key exclusion criteria (2 listed)
- medication affecting the cardiovascular system or metabolism
- metabolic, musculoskeletal, cardiovascular, or other diseases or disorders which may preclude the ability to perform exercise training and testing
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 |
|---|---|---|
| Resistance trainingAlso: Exercise training12-week resistance training intervention | Other | Control group (n=75), Training group (n=362) |
Primary outcome
Change in m. vastus lateralis (VL) cross-sectional area (CSA) after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
VL CSA (cm^2) is determined at mid-thigh using a B-mode axial plane ultrasound (model SSD-α10, Aloka, Tokyo, Japan) with a 13 MHz linear-array probe (60 mm width) in extended-field-of-view mode (23 Hz sampling frequency). However, since Aloka US began to show signs of malfunctioning before the onset of data collection II (approximately four months after the end of data collection I), another US device (Venue Fit R4, GE Medical Systems, USA) was used in data collection II. Due to this US-device change, test-retest measurements at baseline were performed with both devices in data collection II to enable statistical comparison of these devices later. GE-US was used with a L4-20t-RS linear-array probe (48,43 mm width) in extended-field-of-view mode (6/12 MHz, 39 frames per second).
16 secondary outcomes
Change in lower limb maximal strength after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in whole-body volume (cm^3) after 6 and 12-weeks of resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in whole body fat-free mass after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in whole body fat mass after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in waist circumference after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in grip strength after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in maximal vertical jump height after 6 and 12-week resistance training
Time frame: Baseline (test and retest), week 7, week 13
Change in blood count determined from the venous blood sample obtained at morning after overnight fasting before, and after 12-week resistance training
Time frame: Baseline, week 13
Change in C-reactive protein (CRP) determined from the venous blood sample obtained at morning after overnight fasting before and after 12-week resistance training
Time frame: Baseline, week 13
Change in metabolomics determined from the venous blood sample obtained at morning after overnight fasting before and after 12-week resistance training
Time frame: Baseline, week 13
Self-reported measure of physical activity
Time frame: Baseline and after 12-weeks of RT
Sleep self-assessment
Time frame: Baseline and after 12-weeks of RT
Self-report of eating disorder behaviors and attitudes
Time frame: Baseline and after 12-weeks of RT
Self-estimated dietary intake
Time frame: Baseline and after 12-weeks of RT
Self-estimated energy availability
Time frame: Baseline and after 12-weeks of RT
Self-measure of perceived stress
Time frame: Baseline and after 12-weeks of RT
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Apr 2025.
- Individual participant dataSharing planned: Yes. All of the individual participant data collected during the trial, after deidentification.
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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.
Juha P Ahtiainen, Assoc.Prof. principal investigator
University of Jyväskylä, Faculty of Sport and Health Sciences
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Resistance training in people with Exercise Training and Healthy, run by University of Jyvaskyla at 1 site in Finland.
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 3 inclusion and 2 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: finished, as of the sponsor's last update on 16 Apr 2025. 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 Finland. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in m. vastus lateralis (VL) cross-sectional area (CSA) after 6 and 12-week resistance training (time frame: Baseline (test and retest), week 7, week 13). 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 16 Apr 2025.