HealthyChroNuCohortNCT04302922
Association Between the Individual Chronotype and Body Composition in German Students - The ChroNu Study
An observational study of Healthy, run by Paderborn University at 1 site in Germany.
Trial summary
Chronotype is defined as the midpoint of sleep and describes a biological construct of an organism's temporal organisation. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon called "social jetlag". Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- How many people
- 327 participants
- Where
- 1 siteGermany
- Study dates
- 1 Sep 2019to 28 Feb 2023
- 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 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: students of Paderborn University (see inclusion criteria)
Who may be able to join
- Healthy students of Paderborn University
- 18-25 years old
Who cannot join
- Students studying nutrition science
- shift work in the past 3 months
- crossing of >1 time zone in the past 3 months
- pregnancy
- lactation
- intake of medication such as antidepressants or sleeping pills
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Observational Study on the Association Between the Individual Chronotype and Body Composition Among German Students Aged 18 to 25 Years- The ChroNu Cohort
Chronotype is defined as the midpoint of sleep and describes a biological construct of an organism's temporal organisation. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon called "social jetlag". Emerging evidence indicates that both, a later chronotype and/or a substantial "social jetlag" adversely affects metabolic health. Young adults may be particularly vulnerable to these exposures since the chronotype progressively delays from adolescence until early adulthood (approx. 20 years of age) before it advances again. Simultaneously, education in institutions or working hours starts early during the day, potentially contribute to substantial "social jetlag". Data on the development of overweight / obesity prevalence in Germany indicates that rates are now constant or declining in most adult age groups, with the clear exception of young adults, in whom rates continue to be on the rise. Nonetheless, the potential contribution of chronotype and/or social jetlag to this secular trend has not been addressed in Germany. Hence, the hypothesis of the ChroNu cohort is that individual chronotype and social jetlag are predictors of (changes in) the body composition in young adulthood (ages 18-25 years) and that changes in chronotype / social jetlag will result in changes in body composition. The ChroNu cohort forms part of the overall ChroNu study, which addresses the hypothesis that timing of food intake which diverges from the individual chronotype constitutes a characteristic of social jetlag which has adverse short- and long-term consequences for metabolic health (see The ChroNustudy). This study will recruit 300 healthy, non-obese students aged 18-25 years enrolled at Paderborn University until February 2020 and follow these up one year later. Chronotype and social jetlag will be determined using the validated MCTQ. Body composition will be assessed by bioimpedance analysis (BIA) The ChroNu cohort study will reveal important information on the relevance of a biologically determined phenomenon, i.e. the chronotype and the potentially resultant social jetlag for body composition development in a population vulnerable to increases in body fat.
Read the detailed description
Background:
The chronotype is defined as the midpoint of sleep and describes biological construct of an organisms temporal organisation. It is itself determined by genetics, age, sex, and environment. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon which has been called "social jetlag". Emerging evidence indicates that a later chronotype and/or "social jetlag" predisposes to weight gain, higher BMI and higher odds for type 2 diabetes. A later chronotype has been also associated with a more adverse body composition. Since the chronotype progressively delays from adolescence until early adulthood (approx. 20 years of age), before it advances again, young adults may be particularly vulnerable to such adverse exposures. These exposures may result of a higher evening energy intake which in turn was observed for a later chronotype at adolescence. A preferred consumption of energy intake in the evening lead to higher total energy intake. Social schedules such as early starting hours at schools and universities, which potentially contribute to substantial "social jetlag", may influence individual meal timing. The chronotype, however, may be the main predictor for meal timing like skipping breakfast or not. However, it is not clear yet whether this affects predominantly early or late chronotypes in young adults.
Data on the development of overweight / obesity prevalence in Germany indicates that rates are now constant or declining in most adult age groups, with the clear exception of young adults, in whom rates continue to be on the rise. Nonetheless, the potential contribution of chronotype and/or social jetlag to this secular trend has not been addressed in Germany.
Hypothesis:
The hypothesis of the ChroNu cohort is that individual chronotype and social jetlag are predictors of (changes in) body composition in young adulthood (ages 18-25 years) and that changes in chronotype / social jetlag will result in changes in body composition.
Aim:
Hence, the investigators aim to study the association between the body composition and the chronotype / social jetlag at first stage and in a follow-up after one year the causal relationship between changes in chronotype/social jetlag and body composition.
Methods 1: participants In the ChroNu cohort study, the investigators will recruit at least 300 students from Paderborn University aged 18 -25 years. Students will be contacted via social media, mailing-lists, poster and flyer, and presentation of the study in lectures. The ChroNu cohort study will last from Sept 2019 to approximately Febr 2020. Due to the restrictions caused by the SARS-CoV2 pandemic, participants were recruited again in June 2020 to fill in an online survey consisting of the same questionairies as at baselineThe follow-up is scheduled for May - June 2022.
Methods 2: Methods:
In the screening of participants for ChroNu cohort study, eligible participants are asked to fill in the Munich Chronotype Questionnaire (MCTQ, © Roenneberg \& co-workers 2015), which is a validated questionnaire to calculate the individual chronotype. In this questionnaire, participants are asked about their sleep timing separately for work days and work-free days: when they go to bed (bed time); when they prepare to sleep); how long it takes them to fall asleep (sleep latency); when they wake up (sleep end); and how long it takes them to get out of bed (sleep inertia). The mid-sleep point, which defines the chronotype, is calculated as the time when falling asleep plus half of the sleep duration. If the sleep duration is longer on free days than on work days this oversleep is corrected (corrected mid-sleep point): half of the difference in sleep duration is subtracted. Social jet lag is calculated as the difference between the mid-sleep time on work days and work-free days.
The individual body composition, which is the outcome of this study, is analyzed using Bioimpedance Analysis (BIA) (mBCA 515, SECA). For the analyses, waist circumference, body size and body weight are required: waist circumference is measured midway between the lowest rib and the iliac crest by trained personal following the World Health Organisation (WHO) recommendations and entered in the BIA device. Body size is measured by means of an ultrasonic measuring station (seca 287 dp) from SECA and directly transferred to the BIA device. For measurement of body weight and body composition participants need to stand on the BIA device.
Since the chronotype and potentially resultant social jetlag is affected by environment, participants are asked to fill in additional questionnaires on their daily routines and diurnal patterns in both physical activity and meal timing and food intake. Questions on daily routine include start and end time of both university and work if applicable.
For a following ChroNu nutritional trial, the investigators are looking for the earliest and latest chronotypes among our ChoNu cohort. Participants each with the earliest and the latest mid-sleep points among our cohort seem to be suitable.
Statistical analyses Linear mixed-effects regression models are used to analyze the associations between chronotype (continuously in h:mm) as predictor and BMI, body fat, and visceral fat. The same analyses will be performed for social jetlag as predictor.
Multivariable linear and logistic mixed-effects regression models are performed to investigate associations between the chronotype and the circadian patterns of meal timing and physical activity. In second step, multivariable regression analysis is used to examine if the assocation between chronotype and body composition is mediated by the circadian patterns of both meal timing and physical activity. All basic models will be adjusted for age and additionally adjusted for potentially confounders which were considered as statistically significant.
- Conditions
- Healthy
- Keywords
- Chronotype, social jetlag, body composition, meal timing, timing of physical activity
What is being measured
The primary outcome is the main question the study is designed to answer.
Change of body fat content from pre-post Covid-19 pandemic
Body fat content [kg] is measured by bio-impedance analysis (BIA)
Measured: Body fat will be measured both at baseline after enrolment and post-pandemic (follow up).
Secondary outcomes (7)
Change in weight from pre-post Covid-19 pandemic
Body weight is measured in kilograms simultaneously when participants are measured for body composition on the BIA device.
Measured: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in height from pre-post Covid-19 pandemic
Body height is measured in meters simultaneously when participants are measured for body composition on the BIA device.
Measured: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in BMI from pre-post Covid-19 pandemic
Weight and height will be combined to report BMI in kg/m^2
Measured: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in waist circumference from pre-post Covid-19 pandemic
Waist circumference is measured midway between the lowest rib and the iliac crest in centimeters.
Measured: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in daily routine and physical activity from pre-post Covid-19 pandemic
Participants are asked to fill in additional questionnaires on diurnal patterns of physical activity. The scale is the frequency of physical activity with the maximum value being "every day" and the minimum value being "never". All questionnaires are based on the last 4 weeks comparable to the time frame to calculate the chronotype.
Measured: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
Change in meal timing from pre-post Covid-19 pandemic
Participants are asked to fill in additional questionnaires on diurnal patterns of meal timing. Participants are asked to select between breakfast, lunch, dinner and snack times on each day. All questionnaires are based on the last 4 weeks comparable to the time frame to calculate the chronotype.
Measured: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
Change in food choice from pre-post Covid-19 pandemic
Food choice: Participants are asked to fill in additional questionnaires on food intake. Food intake is obtained using a food frequency questionnaire. Questions on beverages are based on the validated German food frequency questionaires (FFQ) "Studie zur Gesundheit Erwachsener in Deutschland" (DEGS). Food intake is based on FFQ, which has not been validated yet, additional to DEGS. Only those questions were selected that ask about the food frequency of different carbohydrate sources. All questionnaires are based on the last 4 weeks comparable to the time frame to calculate the chronotype.
Measured: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2020
- Study start1 Sep 2019
- Primary completion29 Feb 2020
- Study completion28 Feb 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 327 participants (actual)
Sponsor and investigators
- Lead sponsor
- Paderborn University
- Sponsor type
- University, hospital or other
- Collaborators
- German Research Foundation
- Responsible party
- Principal investigator, Anette Buyken, Paderborn University
- Investigators
- Anette E Buyken, Prof. Dr., Principal investigator, Paderborn University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04302922
- Sponsor's protocol ID
- BU 1807/3-2
- Acronym
- ChroNuCohort
- Status last verified
- Apr 2024
- First submitted
- 22 Jan 2020
- Last updated
- 3 Apr 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: It is not yet known if there will be a plan to make IPD available.
Study at a glance
From the registry record, last updated by the sponsor on 3 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Observational Study on the Association Between the Individual Chronotype and Body Composition Among German Students Aged 18 to 25 Years- The ChroNu Cohort
- ClinicalTrials.gov ID
- NCT04302922
- Acronym / sponsor ID
- ChroNuCohort / BU 1807/3-2
- Conditions
- Healthy
- Keywords
- Chronotype, social jetlag, body composition, meal timing, timing of physical activity
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 327 participants (actual)
- Lead sponsor
- Paderborn UniversityUniversity, hospital or other
- Collaborators
- German Research Foundation
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 29 Feb 2020 (actual)
- Study completion
- 28 Feb 2023 (actual)
- First posted
- 10 Mar 2020 (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.
Chronotype is defined as the midpoint of sleep and describes a biological construct of an organism's temporal organisation. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon called "social jetlag". Emerging evidence indicates that both, a later chronotype and/or a substantial "social jetlag" adversely affects metabolic health. Young adults may be particularly vulnerable to these exposures since the chronotype progressively delays from adolescence until early adulthood (approx. 20 years of age) before it advances again. Simultaneously, education in institutions or working hours starts early during the day, potentially contribute to substantial "social jetlag". Data on the development of overweight / obesity prevalence in Germany indicates that rates are now constant or declining in most adult age groups, with the clear exception of young adults, in whom rates continue to be on the rise. Nonetheless, the potential contribution of chronotype and/or social jetlag to this secular trend has not been addressed in Germany. Hence, the hypothesis of the ChroNu cohort is that individual chronotype and social jetlag are predictors of (changes in) the body composition in young adulthood (ages 18-25 years) and that changes in chronotype / social jetlag will result in changes in body composition. The ChroNu cohort forms part of the overall ChroNu study, which addresses the hypothesis that timing of food intake which diverges from the individual chronotype constitutes a characteristic of social jetlag which has adverse short- and long-term consequences for metabolic health (see The ChroNustudy). This study will recruit 300 healthy, non-obese students aged 18-25 years enrolled at Paderborn University until February 2020 and follow these up one year later. Chronotype and social jetlag will be determined using the validated MCTQ. Body composition will be assessed by bioimpedance analysis (BIA) The ChroNu cohort study will reveal important information on the relevance of a biologically determined phenomenon, i.e. the chronotype and the potentially resultant social jetlag for body composition development in a population vulnerable to increases in body fat.
Detailed description
Background:
The chronotype is defined as the midpoint of sleep and describes biological construct of an organisms temporal organisation. It is itself determined by genetics, age, sex, and environment. Misalignment between the individual chronotype and socially determined schedules may result in a phenomenon which has been called "social jetlag". Emerging evidence indicates that a later chronotype and/or "social jetlag" predisposes to weight gain, higher BMI and higher odds for type 2 diabetes. A later chronotype has been also associated with a more adverse body composition. Since the chronotype progressively delays from adolescence until early adulthood (approx. 20 years of age), before it advances again, young adults may be particularly vulnerable to such adverse exposures. These exposures may result of a higher evening energy intake which in turn was observed for a later chronotype at adolescence. A preferred consumption of energy intake in the evening lead to higher total energy intake. Social schedules such as early starting hours at schools and universities, which potentially contribute to substantial "social jetlag", may influence individual meal timing. The chronotype, however, may be the main predictor for meal timing like skipping breakfast or not. However, it is not clear yet whether this affects predominantly early or late chronotypes in young adults.
Data on the development of overweight / obesity prevalence in Germany indicates that rates are now constant or declining in most adult age groups, with the clear exception of young adults, in whom rates continue to be on the rise. Nonetheless, the potential contribution of chronotype and/or social jetlag to this secular trend has not been addressed in Germany.
Hypothesis:
The hypothesis of the ChroNu cohort is that individual chronotype and social jetlag are predictors of (changes in) body composition in young adulthood (ages 18-25 years) and that changes in chronotype / social jetlag will result in changes in body composition.
Aim:
Hence, the investigators aim to study the association between the body composition and the chronotype / social jetlag at first stage and in a follow-up after one year the causal relationship between changes in chronotype/social jetlag and body composition.
Methods 1: participants In the ChroNu cohort study, the investigators will recruit at least 300 students from Paderborn University aged 18 -25 years. Students will be contacted via social media, mailing-lists, poster and flyer, and presentation of the study in lectures. The ChroNu cohort study will last from Sept 2019 to approximately Febr 2020. Due to the restrictions caused by the SARS-CoV2 pandemic, participants were recruited again in June 2020 to fill in an online survey consisting of the same questionairies as at baselineThe follow-up is scheduled for May - June 2022.
Methods 2: Methods:
In the screening of participants for ChroNu cohort study, eligible participants are asked to fill in the Munich Chronotype Questionnaire (MCTQ, © Roenneberg \& co-workers 2015), which is a validated questionnaire to calculate the individual chronotype. In this questionnaire, participants are asked about their sleep timing separately for work days and work-free days: when they go to bed (bed time); when they prepare to sleep); how long it takes them to fall asleep (sleep latency); when they wake up (sleep end); and how long it takes them to get out of bed (sleep inertia). The mid-sleep point, which defines the chronotype, is calculated as the time when falling asleep plus half of the sleep duration. If the sleep duration is longer on free days than on work days this oversleep is corrected (corrected mid-sleep point): half of the difference in sleep duration is subtracted. Social jet lag is calculated as the difference between the mid-sleep time on work days and work-free days.
The individual body composition, which is the outcome of this study, is analyzed using Bioimpedance Analysis (BIA) (mBCA 515, SECA). For the analyses, waist circumference, body size and body weight are required: waist circumference is measured midway between the lowest rib and the iliac crest by trained personal following the World Health Organisation (WHO) recommendations and entered in the BIA device. Body size is measured by means of an ultrasonic measuring station (seca 287 dp) from SECA and directly transferred to the BIA device. For measurement of body weight and body composition participants need to stand on the BIA device.
Since the chronotype and potentially resultant social jetlag is affected by environment, participants are asked to fill in additional questionnaires on their daily routines and diurnal patterns in both physical activity and meal timing and food intake. Questions on daily routine include start and end time of both university and work if applicable.
For a following ChroNu nutritional trial, the investigators are looking for the earliest and latest chronotypes among our ChoNu cohort. Participants each with the earliest and the latest mid-sleep points among our cohort seem to be suitable.
Statistical analyses Linear mixed-effects regression models are used to analyze the associations between chronotype (continuously in h:mm) as predictor and BMI, body fat, and visceral fat. The same analyses will be performed for social jetlag as predictor.
Multivariable linear and logistic mixed-effects regression models are performed to investigate associations between the chronotype and the circadian patterns of meal timing and physical activity. In second step, multivariable regression analysis is used to examine if the assocation between chronotype and body composition is mediated by the circadian patterns of both meal timing and physical activity. All basic models will be adjusted for age and additionally adjusted for potentially confounders which were considered as statistically significant.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- students of Paderborn University (see inclusion criteria)
Key inclusion criteria (2 listed)
- Healthy students of Paderborn University
- 18-25 years old
Key exclusion criteria (6 listed)
- Students studying nutrition science
- shift work in the past 3 months
- crossing of >1 time zone in the past 3 months
- pregnancy
- lactation
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Change of body fat content from pre-post Covid-19 pandemic
Time frame: Body fat will be measured both at baseline after enrolment and post-pandemic (follow up).
Body fat content [kg] is measured by bio-impedance analysis (BIA)
7 secondary outcomes
Change in weight from pre-post Covid-19 pandemic
Time frame: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in height from pre-post Covid-19 pandemic
Time frame: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in BMI from pre-post Covid-19 pandemic
Time frame: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in waist circumference from pre-post Covid-19 pandemic
Time frame: Anthropometric measurements (weight, height, waist circumference) will be performed together with the BIA measurements both at baseline and post-pandemic (follow-up) and are expected to last approximately 20 minutes each.
Change in daily routine and physical activity from pre-post Covid-19 pandemic
Time frame: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
Change in meal timing from pre-post Covid-19 pandemic
Time frame: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
Change in food choice from pre-post Covid-19 pandemic
Time frame: The questionaires concerning daily routine, physical activity, meal timing and food frequency will be performed at baseline and post-pandemic (follow-up) and are expected to last approximately 45 minutes each.
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 3 Apr 2024.
- Individual participant dataSharing planned: Undecided. It is not yet known if there will be a plan to make IPD available.
Related trials for Healthy
Recruiting
THE EFFECTS OF GAME-BASED EXERCISE PROGRAMS
Physical Activity, Body Image
Not yet recruitingPhase 1
A Phase I Study of GLR2053 Tablets in Chinese Healthy Adult Participants
Atopic Dermatitis
Recruiting
Colon-delivered Riboflavin and Gut Microbiota Composition
Microbiome Dysbiosis, Gut Health
Not yet recruiting
Neuroergonomic Analysis of a Brain-Computer Interface Device (BCI)
Healthy Volunteers - Male and Female
RecruitingPhase 1
First-in-Human Trial to Assess REGN20423 in Healthy Adult Participants and Adult Participants With Atopic Dermatitis
Healthy Volunteer, Atopic Dermatitis
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.
Anette E Buyken, Prof. Dr. principal investigator
Paderborn 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 Healthy, run by Paderborn University at 1 site in Germany.
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 6 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 3 Apr 2024. 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 Germany. 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 of body fat content from pre-post Covid-19 pandemic (time frame: Body fat will be measured both at baseline after enrolment and post-pandemic (follow up).). 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 3 Apr 2024.