Conditions Influencing Health StatusSuppWFPBDNCT03976479
Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Plant-Based Diet
An observational study of Conditions Influencing Health Status and Body Weight, run by Boštjan Jakše at 1 site in Slovenia.
Trial summary
There is an objective lack of data on the body composition, nutritional status, cardiovascular status and lifestyle of adults on a plant-based diet (PBD). The aim in this cross-sectional study investigators will document the differences in the body composition, nutritional intake and general health status of healthy… Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Conditions Influencing Health Status, Body Weight, Lipid Metabolism Disorders
- What is being tested?
- Body composition, questionnaires, biochemistry and blood pressure results
- How many people
- 166 participants
- Where
- 1 siteSlovenia
- Study dates
- 28 May 2019to 30 Aug 2019
- 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 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Heatlhy and active long-term PB dieters
Who may be able to join
- Adults, age from 18-80 years, on PBD longer than 0.5 years.
- PB dieters who may have some kind of food intolerance or food restriction (e.g. gluten, tomato, peanuts, citrus, etc.).
- No restriction on participants current BMI
- Knowing (BIA measured) PB dieters baseline BM and fat %
- Currently smoking tobacco products is not an exclusion criterion, but we will record it and report in demographic data
Who cannot join
- Adults on PBD but with active diseases (e.g. cardiovascular diseases, type 2 diabetes, cancer, autoimmune and neurodegenerative disease ect.).
- Adults on PBD with the current use of drugs for measured blood markers (lipids and blood pressure).
- Without major musculoskeletal restrictions
- Pregnant and lactating woman
- Currently competitive or top level athletes
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet
There is an objective lack of data on the body composition, nutritional status, cardiovascular status and lifestyle of adults on a plant-based diet (PBD). The aim in this cross-sectional study investigators will document the differences in the body composition, nutritional intake and general health status of healthy adults aged 18 to 80 years who are on plant-based diet of 0.5-10 years and to determine if their body composition status is associated to the duration of eating with PBD between the 3 groups: those that are 0.5-2 years (short-term), 2-5 years (medium-term) and 5-10 years (long-term) on PBD.
This study will also include the monitoring of other factors of healthy and active lifestyle of PBD participants, namely the status of habitual and organized physical activity, the status of daily long-term seating, the status of stress and hygiene of sleep, socio-economic status and the motive(s)/reasons for starting PBD. Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data from participants, blood analysis to collect their basic biochemistry results, and data on current blood pressure status.
Read more
The investigators hypothesis is that:
(H1): There are no differences in nutritional status between people who are short- (0.5-2 years), the medium- (2-5 years) or the long-term (5-10 years) on PBD.
(H2): At least 80% of the tested subjects have plasma lipid values and blood pressure within the reference values.
(H3): There is difference in lipid profile and body composition between people who are short- and the medium but not between medium and long-term PBD.
Read the detailed description
In the study investigators will voluntarily enroll all participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators will anticipate that for approx. 150-200 healthy adult PBD participants investigators will require approx. 2555 invited and interviewed candidates, of both sexes, aged 18-80 years, without restrictions on current body mass index (BMI) status, that are on PBD for 0.5-10 years and live a healthy and active lifestyle.
The methods to be used are a medically approved bioimpedance body composition monitor (Tanita, 780 S MA, Tokyo, Japan), medically approved body weight scale and body height gauge (MPE 250K100HM), a 3-day dietary record (3-DR), one adopted by NIH: socio-demographic, economic status and motive for PBD questionnaire, and three standardized questionnaires: (1) habitual and organized physical activity, and the frequency of sitting (IPAQ-long), (2) stress (PSQ-30), and (3) quality of sleep (PSQI).
Concerning 3-DR, the study participants will weight and record all foods, beverages consumed, as well as leftovers, and dietary supplements over three consecutive days (two weekdays and one weekend) using electronic kitchen scales. The study participants will choose the day of the beginning of dietary recording within a given period (i. e.: Sunday, Monday, Tuesday or Thursday, Friday, Saturday). When exact weighing will not be possible (e.g., in case of eating out), household measures (spoon, cup, glass, etc.) and a picture book with household measures in adults' portion sizes (photos of reference foods with their actual gram weight) (NIJZ, 2016), allowed semi-quantitative recording. For the evaluation of dietary intake, investigators will use dietary software, Open Platform for Clinical Nutrition (OPEN), which is a web-based application (http://opkp.si/) and has been developed by the Jozef Stefan Institute and supported by the EuroFIR AISBL (http://eurofir.org) and the European Federation of the Association of Dietitians (EFAD). Dietary software has been upgraded to 3-DR methodology.
Food intake data (from 3-DR) will be used for assessment of energy, macro- and micronutrients intakes using OPEN. The energy and nutrient contents of commercial food or home prepared foods, will estimated by recipe simulation using labelled ingredients and nutrient contents. OPEN will be continuously updated by adding those products or recopies recorded by study participants on PBD.
In order to assess the nutritional intake from dietary supplements, we will use Res-Pons d.o.o. services, which professionally manages the database with all dietary supplements products on the Slovenian market (Pretehtajte.si, 2018).
Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data taken blood analysis to collect their basic biochemistry results, measured in a standard and comparable method (plasma lipids, uric acid and a hemogram), and data on current blood pressure status.
- Conditions
- Conditions Influencing Health Status, Body Weight, Lipid Metabolism Disorders, Uricemia, Blood Pressure Disorders, Physical Stress
- Being tested
- Body composition, questionnaires, biochemistry and blood pressure results
- Keywords
- Body composition, Nutritional status, Lipids, Blood pressure, Lifestyle factors
- Medical subject headings
- Body Weight, Lipid Metabolism Disorders, Hyperuricemia, Sleep Wake Disorders, Stress, Psychological
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Body composition, questionnaires, biochemistry and blood pressure resultsOther
Body composition status, nutritional status, cardiovasculat status, health status, lifestyle factors
What is being measured
The primary outcome is the main question the study is designed to answer.
Body weight status
Body weight measured with medically approved weighing scale
Measured: Cross-sectional (June-July 2019)
Height status
Height status measured with medically approved weighing scale with height rod
Measured: Cross-sectional (June-July 2019)
Body mass index (BMI) status
Measured weight and height will be combined to report BMI in kg/m^2
Measured: Cross-sectional (June-July 2019)
Lean tissue mass status
Lean tissue mass measured with medically approved bioimpedance analysis
Measured: Cross-sectional (June-July 2019)
Fat tissue mass status
Fat tissue mass measured with medically approved bioimpedance analysis
Measured: Cross-sectional (June-July 2019)
Nutritional status
Nutrititional status measured with 3-day dietary record (3-DR)
Measured: Cross-sectional (June-July 2019)
Serum cholesterol status
Serum total cholesterol concentration
Measured: Cross-sectional (June-July 2019)
Oxidized Low Density Lipoprotein (LDL)-cholesterol status
Serum concentration of oxidized LDL-cholesterol
Measured: Cross-sectional (June-July 2019)
Serum HDL cholesterol status
Serum HDL cholesterol contentration
Measured: Cross-sectional (June-July 2019)
Serum triglyceride status
Serum triglyceride concentrations
Measured: Cross-sectional (June-July 2019)
Blood pressure status
Blood pressure status
Measured: Cross-sectional (June-July 2019)
Secondary outcomes (6)
Socio-economic and demographic status
Socio-economic and demographic status measured using Nutritional behaviours of adults Slovenians from the point of of health prevention questionnaire (Slovenian NIH)
Measured: Cross-sectional (June-July 2019)
Physical activity status
Physical activity status measured by The International Physical Activity Questionnaires (IPAQ)
Measured: Cross-sectional (June-July 2019)
Stress status
Stress status measured with Perceived Stress Questionnaire (PSQ)
Measured: Cross-sectional (June-July 2019)
Sleep status
Sleep status measured with The Pittsburgh Sleep Quality Index (PSQI)
Measured: Cross-sectional (June-July 2019)
Serum uric acid status
Serum uric acid concentration (safety outcome)
Measured: Cross-sectional (June-July 2019)
Hemoglobin status
Hemoglobin concentration (safety outcome)
Measured: Cross-sectional (June-July 2019)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2019
- Study start28 May 2019
- Primary completion30 Jul 2019
- Study completion30 Aug 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (4)Papers the sponsor has linked to this study.
- Other trials for Conditions Influencing Health StatusStudies 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
- Cross-sectional
- Enrolment
- 166 participants (actual)
Sponsor and investigators
- Lead sponsor
- Boštjan Jakše
- Sponsor type
- University, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Responsible party
- Sponsor-investigator, Boštjan Jakše, Barbara Jakše s.p.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03976479
- Sponsor's protocol ID
- KR3
- Acronym
- SuppWFPBD
- Status last verified
- Nov 2019
- First submitted
- 1 Jun 2019
- Last updated
- 2 Dec 2019
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Publications
Karlsen MC, Rogers G, Miki A, Lichtenstein AH, Folta SC, Economos CD, Jacques PF, Livingston KA, McKeown NM. Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Nutrients. 2019 Mar 14;11(3):625. doi: 10.3390/nu11030625.
PubMed 30875784Melina V, Craig W, Levin S. Position of the Academy of Nutrition and Dietetics: Vegetarian Diets. J Acad Nutr Diet. 2016 Dec;116(12):1970-1980. doi: 10.1016/j.jand.2016.09.025.
PubMed 27886704Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.
PubMed 28728684Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
PubMed 30660336
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Body Composition, Nutritional and Cardiovascular Status and Lifestyle Factors of Adults Who Are on Short-, Medium- and Long-term Plant-Based Diet
- ClinicalTrials.gov ID
- NCT03976479
- Acronym / sponsor ID
- SuppWFPBD / KR3
- Conditions
- Conditions Influencing Health Status, Body Weight, Lipid Metabolism Disorders, Uricemia, Blood Pressure Disorders, Physical Stress
- Keywords
- Body composition, Nutritional status, Lipids, Blood pressure, Lifestyle factors
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 166 participants (actual)
- Lead sponsor
- Boštjan JakšeUniversity, hospital or other
- Collaborators
- University Medical Centre Ljubljana
- Study start
- 28 May 2019 (actual)
- Primary completion
- 30 Jul 2019 (actual)
- Study completion
- 30 Aug 2019 (actual)
- First posted
- 6 Jun 2019 (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.
There is an objective lack of data on the body composition, nutritional status, cardiovascular status and lifestyle of adults on a plant-based diet (PBD). The aim in this cross-sectional study investigators will document the differences in the body composition, nutritional intake and general health status of healthy adults aged 18 to 80 years who are on plant-based diet of 0.5-10 years and to determine if their body composition status is associated to the duration of eating with PBD between the 3 groups: those that are 0.5-2 years (short-term), 2-5 years (medium-term) and 5-10 years (long-term) on PBD.
This study will also include the monitoring of other factors of healthy and active lifestyle of PBD participants, namely the status of habitual and organized physical activity, the status of daily long-term seating, the status of stress and hygiene of sleep, socio-economic status and the motive(s)/reasons for starting PBD. Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data from participants, blood analysis to collect their basic biochemistry results, and data on current blood pressure status.
The investigators hypothesis is that:
(H1): There are no differences in nutritional status between people who are short- (0.5-2 years), the medium- (2-5 years) or the long-term (5-10 years) on PBD.
(H2): At least 80% of the tested subjects have plasma lipid values and blood pressure within the reference values.
(H3): There is difference in lipid profile and body composition between people who are short- and the medium but not between medium and long-term PBD.
Detailed description
In the study investigators will voluntarily enroll all participants within inclusion/exclusion criteria that are willing to participate in the study. Investigators will anticipate that for approx. 150-200 healthy adult PBD participants investigators will require approx. 2555 invited and interviewed candidates, of both sexes, aged 18-80 years, without restrictions on current body mass index (BMI) status, that are on PBD for 0.5-10 years and live a healthy and active lifestyle.
The methods to be used are a medically approved bioimpedance body composition monitor (Tanita, 780 S MA, Tokyo, Japan), medically approved body weight scale and body height gauge (MPE 250K100HM), a 3-day dietary record (3-DR), one adopted by NIH: socio-demographic, economic status and motive for PBD questionnaire, and three standardized questionnaires: (1) habitual and organized physical activity, and the frequency of sitting (IPAQ-long), (2) stress (PSQ-30), and (3) quality of sleep (PSQI).
Concerning 3-DR, the study participants will weight and record all foods, beverages consumed, as well as leftovers, and dietary supplements over three consecutive days (two weekdays and one weekend) using electronic kitchen scales. The study participants will choose the day of the beginning of dietary recording within a given period (i. e.: Sunday, Monday, Tuesday or Thursday, Friday, Saturday). When exact weighing will not be possible (e.g., in case of eating out), household measures (spoon, cup, glass, etc.) and a picture book with household measures in adults' portion sizes (photos of reference foods with their actual gram weight) (NIJZ, 2016), allowed semi-quantitative recording. For the evaluation of dietary intake, investigators will use dietary software, Open Platform for Clinical Nutrition (OPEN), which is a web-based application (http://opkp.si/) and has been developed by the Jozef Stefan Institute and supported by the EuroFIR AISBL (http://eurofir.org) and the European Federation of the Association of Dietitians (EFAD). Dietary software has been upgraded to 3-DR methodology.
Food intake data (from 3-DR) will be used for assessment of energy, macro- and micronutrients intakes using OPEN. The energy and nutrient contents of commercial food or home prepared foods, will estimated by recipe simulation using labelled ingredients and nutrient contents. OPEN will be continuously updated by adding those products or recopies recorded by study participants on PBD.
In order to assess the nutritional intake from dietary supplements, we will use Res-Pons d.o.o. services, which professionally manages the database with all dietary supplements products on the Slovenian market (Pretehtajte.si, 2018).
Investigators will also record their maximum (lifetime) body weight, body weight upon entering the PBD lifestyle, and using data taken blood analysis to collect their basic biochemistry results, measured in a standard and comparable method (plasma lipids, uric acid and a hemogram), and data on current blood pressure status.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Heatlhy and active long-term PB dieters
Key inclusion criteria (5 listed)
- Adults, age from 18-80 years, on PBD longer than 0.5 years.
- PB dieters who may have some kind of food intolerance or food restriction (e.g. gluten, tomato, peanuts, citrus, etc.).
- No restriction on participants current BMI
- Knowing (BIA measured) PB dieters baseline BM and fat %
- Currently smoking tobacco products is not an exclusion criterion, but we will record it and report in demographic data
Key exclusion criteria (5 listed)
- Adults on PBD but with active diseases (e.g. cardiovascular diseases, type 2 diabetes, cancer, autoimmune and neurodegenerative disease ect.).
- Adults on PBD with the current use of drugs for measured blood markers (lipids and blood pressure).
- Without major musculoskeletal restrictions
- Pregnant and lactating woman
- Currently competitive or top level athletes
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 |
|---|---|---|
| Body composition, questionnaires, biochemistry and blood pressure resultsBody composition status, nutritional status, cardiovasculat status, health status, lifestyle factors | Other | – |
Primary outcome
Body weight status
Time frame: Cross-sectional (June-July 2019)
Body weight measured with medically approved weighing scale
Height status
Time frame: Cross-sectional (June-July 2019)
Height status measured with medically approved weighing scale with height rod
Body mass index (BMI) status
Time frame: Cross-sectional (June-July 2019)
Measured weight and height will be combined to report BMI in kg/m^2
Lean tissue mass status
Time frame: Cross-sectional (June-July 2019)
Lean tissue mass measured with medically approved bioimpedance analysis
Fat tissue mass status
Time frame: Cross-sectional (June-July 2019)
Fat tissue mass measured with medically approved bioimpedance analysis
Nutritional status
Time frame: Cross-sectional (June-July 2019)
Nutrititional status measured with 3-day dietary record (3-DR)
Serum cholesterol status
Time frame: Cross-sectional (June-July 2019)
Serum total cholesterol concentration
Oxidized Low Density Lipoprotein (LDL)-cholesterol status
Time frame: Cross-sectional (June-July 2019)
Serum concentration of oxidized LDL-cholesterol
Serum HDL cholesterol status
Time frame: Cross-sectional (June-July 2019)
Serum HDL cholesterol contentration
Serum triglyceride status
Time frame: Cross-sectional (June-July 2019)
Serum triglyceride concentrations
Blood pressure status
Time frame: Cross-sectional (June-July 2019)
Blood pressure status
6 secondary outcomes
Socio-economic and demographic status
Time frame: Cross-sectional (June-July 2019)
Physical activity status
Time frame: Cross-sectional (June-July 2019)
Stress status
Time frame: Cross-sectional (June-July 2019)
Sleep status
Time frame: Cross-sectional (June-July 2019)
Serum uric acid status
Time frame: Cross-sectional (June-July 2019)
Hemoglobin status
Time frame: Cross-sectional (June-July 2019)
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 2 Dec 2019.
- Background: PubMed 30875784Karlsen MC, Rogers G, Miki A, Lichtenstein AH, Folta SC, Economos CD, Jacques PF, Livingston KA, McKeown NM. Theoretical Food and Nutrient Composition of Whole-Food Plant-Based and Vegan Diets Compared to Current Dietary Recommendations. Nutrients. 2019 Mar 14;11(3):625. doi: 10.3390/nu11030625.
- Background: PubMed 27886704Melina V, Craig W, Levin S. Position of the Academy of Nutrition and Dietetics: Vegetarian Diets. J Acad Nutr Diet. 2016 Dec;116(12):1970-1980. doi: 10.1016/j.jand.2016.09.025.
- Background: PubMed 28728684Satija A, Bhupathiraju SN, Spiegelman D, Chiuve SE, Manson JE, Willett W, Rexrode KM, Rimm EB, Hu FB. Healthful and Unhealthful Plant-Based Diets and the Risk of Coronary Heart Disease in U.S. Adults. J Am Coll Cardiol. 2017 Jul 25;70(4):411-422. doi: 10.1016/j.jacc.2017.05.047.
- Background: PubMed 30660336Willett W, Rockstrom J, Loken B, Springmann M, Lang T, Vermeulen S, Garnett T, Tilman D, DeClerck F, Wood A, Jonell M, Clark M, Gordon LJ, Fanzo J, Hawkes C, Zurayk R, Rivera JA, De Vries W, Majele Sibanda L, Afshin A, Chaudhary A, Herrero M, Agustina R, Branca F, Lartey A, Fan S, Crona B, Fox E, Bignet V, Troell M, Lindahl T, Singh S, Cornell SE, Srinath Reddy K, Narain S, Nishtar S, Murray CJL. Food in the Anthropocene: the EAT-Lancet Commission on healthy diets from sustainable food systems. Lancet. 2019 Feb 2;393(10170):447-492. doi: 10.1016/S0140-6736(18)31788-4. Epub 2019 Jan 16. No abstract available.
- NIJZ, Slikovno-gradivo-za-dolocanje-vnosa-zivil, 2016. Available at: http://www.nijz.si/sl/publikacije/slikovno-gradivo-za-dolocanje-vnosa-zivil , assesed 30.05.2019Link provided by the sponsor.
- OPEN Platform for Clinical NutritionLink provided by the sponsor.
- EuroFIR AISBLLink provided by the sponsor.
- Res Pons d.o.o.Link provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Conditions Influencing Health Status and Body Weight, run by Boštjan Jakše at 1 site in Slovenia.
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 5 inclusion and 5 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 2 Dec 2019. 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 Slovenia. 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?
Body weight status (time frame: Cross-sectional (June-July 2019)). The study lists 11 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03976479, which also lists 4 linked publications.
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 2 Dec 2019.