Metabolic SyndromeNCT04502329
Does the Energy Restriction Intermittent Fasting Diet Alleviate Metabolic Syndrome Biomarkers?
A study testing Diet in people with Metabolic Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
Trial summary
The aim of this randomized controlled study determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic institution in Istanbul,Turkey. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Metabolic Syndrome
- What is being tested?
- Diet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 65 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 30 Jan 2019to 10 Jun 2020
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Being between the ages of 18-65
- Body mass index to be 27 and above
- Clinical diagnosis of metabolic syndrome according to the criteria of IDF 2005 or NCP ATP III.
Who cannot join
- Being in the pre-menopausal or menopause
- Following a special diet (such as Celiac, Type 1 diabetes)
- Using a special nutritional supplement (omega 3, probiotic, vitamin-mineral, teff seed etc.)
- Those who do not comply with the diet, pregnant, being lactating
- Doing heavy physical activity or working in a heavy job
- Presence of liver, kidney or immune deficiency
Show all 9Show fewer
- Conditions that will seriously affect weight management such as having bariatric surgery
- Determined to have had an unintentional sudden weight loss of more than 5% in the last three months
- Not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks before the study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Effect of Intermittent Fasting Diet on Metabolic Syndrome Biomarkers and Weight Management in Individuals With Metabolic Syndrome
The aim of this randomized controlled study determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic institution in Istanbul,Turkey. Subjects were divided into two groups; IER (Intermittent Energy Restriction-intervention group, calori restriction of 300-500kcal/d combined with 16:8 model Intermittent Fasting) and CER (Countinous Energy Restriction- control group continous restriction of 300-500kcal/d). Assessment was ascertained at baseline and 12 weeks. Blood samples were analyzed for lipid profile, fasting plasma glucose, ınsulin, HOMA-IR. Blood pressure and body composition were evaluated.
Read the detailed description
Aim The aim of this study; determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults.
Subjects Participants who referred by clinician, as medical doctors after physical assesment selected in this study were recruited among patients with metabolic syndrome referring to the diet clinic local in Turkey. The criteria of inclusion were metabolic syndrome patients, aged 18-65 years had body mass index (BMI) ≥27 kg/m2 with no history of mental or physical disabilities.Subjects should also not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks before the study. Eligible subjects were approached to participate. Only those who agreed to participate were explained of all the information pertaining to this study and were consented. This study was approved by Istanbul Medipol University Ethics Committee.
Study design The aim of A randomized controlled study was carried out to determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. Subjects were randomly assigned into two groups; intervention IER (Intermittent Energy Restriction) and control CER (Continuous Energy Restriction). Randomization, first participant assigned IER group an each eligible participant was randomly assigned to either CER group or IER group. Those who were assigned to two groups needed to adhere dietary regime, with a reduction of 300-500kcal/d from the habitual energy intake for 12 weeks intervention period. Diet menus were prepared taking into account the individual characteristics. IER participants abide by intermittent fasting which time restricted 16:8 model diet. During 16 hours; such as at 04.00 pm- 08.00 am or 05.00 pm - 09.00 am or 07.00 pm - 11.00 am fasting hours, no food and calorie drink. But participants in fasting hours can drink water, sugar free tea and mineral water, coffee without sauce. On the other 8 hours, need to adhere energy restriction diet. Subjects were also provided with seven-day food menu guidelines. Those who were assigned to two groups need to maintain their present lifestyle. Analysis was carried out at two time points: baseline and week 12. In order to ensure good compliance, subjects were contacted once a week via telephone calls. Food diaries and were fasting log book presumed to the participants during each assessment meeting. Subjects were given detailed instruction verbally and a reference guide on how to fill up the food diaries and fasting log. Individual and group counseling were provided before and during the intervention period.
Body composition, Blood Pressure, Biochemical markers Height was measured using SECA-213 portable stadiometer (SECA, Hamburg, Germany). Body composition was measured using TANITA SC-330, body composition analyzer (TANITA Corp. Tokyo, Japan). All measurements were made in the morning at participants fasted state. This instrument was calibrated each time before measurement. Data from this instrument including body weight, BMI, body fat percentage, fat mass, fat free mass and total body water.
Body mass index (BMI) was calculated as; BMI [kg/m2]= Weight[kg] / (Height[m] x Height[m]) Waist circumference was measured by the same dietician with the help of a standard unstretched tape measure. Blood pressure and heart rate were measured using an automatic oscillometric device (Omron M2 Basic, Japanese) after participants had rested in a seated position for 5 min. A blood sample was drawn at baseline and after 12 weeks. Insulin resistance was estimated with the homeostasis model assessment (HOMA-IR) and calculated as; HOMA-IR= (Fasting plasma glucose [mg/dL] x Serum insulin [IU/L]) / 405
Biochemical markers blood lipids, fasting plasma glucose and Haemoglobin A1c (HbA1c) were performed with standard methods. Serum concentrations of insulin were measured by immunonephelometric methods. Adverse events were monitored by standardized questionnaires, diary and at the last study visit by interview.
- Conditions
- Metabolic Syndrome
- Being tested
- Diet
- Keywords
- intermittent fasting, metabolic syndrome, time restricted diet, energy restriction
- Medical subject headings
- Metabolic Syndrome, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DietOther
Energy Restriction Intermittent Fasting Diet
| Study group | Role | What they receive |
|---|---|---|
| IER | Experimental | Intermittent Energy Restriction Receives: Other: Diet |
| CER | No intervention | Continous Energy Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
Average weight and standard deviation of the participants
Weight in kilograms, was measured with TANİTA SC-330 instrument.
Measured: Change from Baseline Weight at 12 weeks
Average height and standard deviation of the participants
Height measured with SECA-213 instrument.
Measured: Baseline
Average Body Mass Indexand standard deviation of the participants
Weight and Height were combined to report BMI in kg/m^2
Measured: Change from Baseline Body Mass Index at 12 weeks
Average Waist circumference and standard deviation of the participants
Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.
Measured: Change from Baseline Weight at 12 weeks
Concentration of Total Cholesterol
Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Concentration of High-Density Cholesterol
High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Concentration of Low-Density Cholesterol
Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Concentration of Triglyceride
Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Concentration of Fasting plasma glucose
Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Concentration of Insülin
Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Rate of HOMA-IR
HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405
Measured: Change from Baseline Weight at 12 weeks
Concentration of HbA1c
HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.
Measured: Change from Baseline Weight at 12 weeks
Amount of Fat mass
Fat mass in kilograms was measured with TANİTA SC-330 instrument.
Measured: Change from Baseline Weight at 12 weeks
Rate of Body fat percentage
Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.
Measured: Change from Baseline Weight at 12 weeks
Amount of Fat free mass
Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.
Measured: Change from Baseline Weight at 12 weeks
Amount of Total body water
Total body water in kilograms, was measured with TANİTA SC-330 instrument.
Measured: Change from Baseline Weight at 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Aug 2020
- Study start30 Jan 2019
- Primary completion10 Mar 2020
- Study completion10 Jun 2020
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 Metabolic SyndromeStudies 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
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized control trial The first participant assigned Intermittent Energy Restriction Group, the others assigned Continous Energy Restricition group or Intertermittent Energy Restriction Group respectively.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 65 participants (actual)
Sponsor and investigators
- Lead sponsor
- Istanbul Medipol University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, yaseminkunduraci, Istanbul Medipol University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04502329
- Sponsor's protocol ID
- 10840098-604.01.01-E.1866
- Status last verified
- Aug 2020
- First submitted
- 15 Jun 2020
- Last updated
- 6 Aug 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
PubMed 32060194Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.
PubMed 31614992Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
PubMed 28715993Antoni R, Johnston KL, Collins AL, Robertson MD. Effects of intermittent fasting on glucose and lipid metabolism. Proc Nutr Soc. 2017 Aug;76(3):361-368. doi: 10.1017/S0029665116002986. Epub 2017 Jan 16.
PubMed 28091348
Study at a glance
From the registry record, last updated by the sponsor on 6 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Intermittent Fasting Diet on Metabolic Syndrome Biomarkers and Weight Management in Individuals With Metabolic Syndrome
- ClinicalTrials.gov ID
- NCT04502329
- Acronym / sponsor ID
- 10840098-604.01.01-E.1866
- Conditions
- Metabolic Syndrome
- Keywords
- intermittent fasting, metabolic syndrome, time restricted diet, energy restriction
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 65 participants (actual)
- Lead sponsor
- Istanbul Medipol University HospitalUniversity, hospital or other
- Study start
- 30 Jan 2019 (actual)
- Primary completion
- 10 Mar 2020 (actual)
- Study completion
- 10 Jun 2020 (actual)
- First posted
- 6 Aug 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.
The aim of this randomized controlled study determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. It was done on metabolic syndrome patients, aged 18-65 years at an academic institution in Istanbul,Turkey. Subjects were divided into two groups; IER (Intermittent Energy Restriction-intervention group, calori restriction of 300-500kcal/d combined with 16:8 model Intermittent Fasting) and CER (Countinous Energy Restriction- control group continous restriction of 300-500kcal/d). Assessment was ascertained at baseline and 12 weeks. Blood samples were analyzed for lipid profile, fasting plasma glucose, ınsulin, HOMA-IR. Blood pressure and body composition were evaluated.
Detailed description
Aim The aim of this study; determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults.
Subjects Participants who referred by clinician, as medical doctors after physical assesment selected in this study were recruited among patients with metabolic syndrome referring to the diet clinic local in Turkey. The criteria of inclusion were metabolic syndrome patients, aged 18-65 years had body mass index (BMI) ≥27 kg/m2 with no history of mental or physical disabilities.Subjects should also not be practicing Muslim Ramadan fasting or had changed their dietary pattern 12 weeks before the study. Eligible subjects were approached to participate. Only those who agreed to participate were explained of all the information pertaining to this study and were consented. This study was approved by Istanbul Medipol University Ethics Committee.
Study design The aim of A randomized controlled study was carried out to determine the efficacy of calorie restriction intermittent fasting diet in metabolic parameters and weight management among metabolic syndromes adults. Subjects were randomly assigned into two groups; intervention IER (Intermittent Energy Restriction) and control CER (Continuous Energy Restriction). Randomization, first participant assigned IER group an each eligible participant was randomly assigned to either CER group or IER group. Those who were assigned to two groups needed to adhere dietary regime, with a reduction of 300-500kcal/d from the habitual energy intake for 12 weeks intervention period. Diet menus were prepared taking into account the individual characteristics. IER participants abide by intermittent fasting which time restricted 16:8 model diet. During 16 hours; such as at 04.00 pm- 08.00 am or 05.00 pm - 09.00 am or 07.00 pm - 11.00 am fasting hours, no food and calorie drink. But participants in fasting hours can drink water, sugar free tea and mineral water, coffee without sauce. On the other 8 hours, need to adhere energy restriction diet. Subjects were also provided with seven-day food menu guidelines. Those who were assigned to two groups need to maintain their present lifestyle. Analysis was carried out at two time points: baseline and week 12. In order to ensure good compliance, subjects were contacted once a week via telephone calls. Food diaries and were fasting log book presumed to the participants during each assessment meeting. Subjects were given detailed instruction verbally and a reference guide on how to fill up the food diaries and fasting log. Individual and group counseling were provided before and during the intervention period.
Body composition, Blood Pressure, Biochemical markers Height was measured using SECA-213 portable stadiometer (SECA, Hamburg, Germany). Body composition was measured using TANITA SC-330, body composition analyzer (TANITA Corp. Tokyo, Japan). All measurements were made in the morning at participants fasted state. This instrument was calibrated each time before measurement. Data from this instrument including body weight, BMI, body fat percentage, fat mass, fat free mass and total body water.
Body mass index (BMI) was calculated as; BMI [kg/m2]= Weight[kg] / (Height[m] x Height[m]) Waist circumference was measured by the same dietician with the help of a standard unstretched tape measure. Blood pressure and heart rate were measured using an automatic oscillometric device (Omron M2 Basic, Japanese) after participants had rested in a seated position for 5 min. A blood sample was drawn at baseline and after 12 weeks. Insulin resistance was estimated with the homeostasis model assessment (HOMA-IR) and calculated as; HOMA-IR= (Fasting plasma glucose [mg/dL] x Serum insulin [IU/L]) / 405
Biochemical markers blood lipids, fasting plasma glucose and Haemoglobin A1c (HbA1c) were performed with standard methods. Serum concentrations of insulin were measured by immunonephelometric methods. Adverse events were monitored by standardized questionnaires, diary and at the last study visit by interview.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized control trial The first participant assigned Intermittent Energy Restriction Group, the others assigned Continous Energy Restricition group or Intertermittent Energy Restriction Group respectively.
| Arm | Type | Receives |
|---|---|---|
| IER | Experimental | Other: DietIntermittent Energy Restriction |
| CER | No intervention | –Continous Energy Restriction |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Being between the ages of 18-65
- Body mass index to be 27 and above
- Clinical diagnosis of metabolic syndrome according to the criteria of IDF 2005 or NCP ATP III.
Key exclusion criteria (9 listed)
- Being in the pre-menopausal or menopause
- Following a special diet (such as Celiac, Type 1 diabetes)
- Using a special nutritional supplement (omega 3, probiotic, vitamin-mineral, teff seed etc.)
- Those who do not comply with the diet, pregnant, being lactating
- Doing heavy physical activity or working in a heavy job
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 |
|---|---|---|
| DietEnergy Restriction Intermittent Fasting Diet | Other | IER |
Primary outcome
Average weight and standard deviation of the participants
Time frame: Change from Baseline Weight at 12 weeks
Weight in kilograms, was measured with TANİTA SC-330 instrument.
Average height and standard deviation of the participants
Time frame: Baseline
Height measured with SECA-213 instrument.
Average Body Mass Indexand standard deviation of the participants
Time frame: Change from Baseline Body Mass Index at 12 weeks
Weight and Height were combined to report BMI in kg/m^2
Average Waist circumference and standard deviation of the participants
Time frame: Change from Baseline Weight at 12 weeks
Waist circumference in centimeters, was measured by the same dietician with the help of unstretched tape measure.
Concentration of Total Cholesterol
Time frame: Change from Baseline Weight at 12 weeks
Total cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of High-Density Cholesterol
Time frame: Change from Baseline Weight at 12 weeks
High Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Low-Density Cholesterol
Time frame: Change from Baseline Weight at 12 weeks
Low Dansity Cholesterol in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Triglyceride
Time frame: Change from Baseline Weight at 12 weeks
Triglyceride in mg/dL, results was provided from participant's clinician before and 12 weeks after diet.
Concentration of Fasting plasma glucose
Time frame: Change from Baseline Weight at 12 weeks
Fasting plasma glucose in mg/dL, was provided from participant's clinician before and 12 weeks after diet.
Concentration of Insülin
Time frame: Change from Baseline Weight at 12 weeks
Insülin in IU/L, was provided from participant's clinician before and 12 weeks after diet.
Rate of HOMA-IR
Time frame: Change from Baseline Weight at 12 weeks
HOMA-IR was calculated with fasting plasma glucose and insülin levels. HOMA-IR = (Fasting plasma glucose [mg/dL] x Insülin [IU/L] ) / 405
Concentration of HbA1c
Time frame: Change from Baseline Weight at 12 weeks
HbA1c what value was stated as a percentage (%), were provided from participant's clinician before and 12 weeks after diet.
Amount of Fat mass
Time frame: Change from Baseline Weight at 12 weeks
Fat mass in kilograms was measured with TANİTA SC-330 instrument.
Rate of Body fat percentage
Time frame: Change from Baseline Weight at 12 weeks
Body fat percentage was calculated combined with weight and fat mass. Body fat percentage = (Body mass [kg] / Weight [kg]) x 100.
Amount of Fat free mass
Time frame: Change from Baseline Weight at 12 weeks
Fat free mass in kilograms, was measured with TANİTA SC-330 instrument.
Amount of Total body water
Time frame: Change from Baseline Weight at 12 weeks
Total body water in kilograms, was measured with TANİTA SC-330 instrument.
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 6 Aug 2020.
- Results publication: PubMed 32060194Welton S, Minty R, O'Driscoll T, Willms H, Poirier D, Madden S, Kelly L. Intermittent fasting and weight loss: Systematic review. Can Fam Physician. 2020 Feb;66(2):117-125.
- Results publication: PubMed 31614992Rynders CA, Thomas EA, Zaman A, Pan Z, Catenacci VA, Melanson EL. Effectiveness of Intermittent Fasting and Time-Restricted Feeding Compared to Continuous Energy Restriction for Weight Loss. Nutrients. 2019 Oct 14;11(10):2442. doi: 10.3390/nu11102442.
- Results publication: PubMed 28715993Patterson RE, Sears DD. Metabolic Effects of Intermittent Fasting. Annu Rev Nutr. 2017 Aug 21;37:371-393. doi: 10.1146/annurev-nutr-071816-064634. Epub 2017 Jul 17.
- Results publication: PubMed 28091348Antoni R, Johnston KL, Collins AL, Robertson MD. Effects of intermittent fasting on glucose and lipid metabolism. Proc Nutr Soc. 2017 Aug;76(3):361-368. doi: 10.1017/S0029665116002986. Epub 2017 Jan 16.
- Individual participant dataSharing planned: No
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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?
A study testing Diet in people with Metabolic Syndrome, run by Istanbul Medipol University Hospital at 1 site in Turkey (Türkiye).
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 9 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 6 Aug 2020. 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 Turkey (Türkiye). 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?
Average weight and standard deviation of the participants (time frame: Change from Baseline Weight at 12 weeks). The study lists 16 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 NCT04502329, 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 6 Aug 2020.