Weight LossNCT04646733
Effect of a Low-carbohydrate, High-protein Energy-restricted Diet on Weight and Body Composition Using DXA
A study testing High Protein Diet Group and No High Protein Diet Group in people with Weight Loss and Body Composition, run by Erik Ramirez Lopez at 1 site in Mexico.
Trial summary
People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. Read more about this study
- Who is it for?
- Ages 20 to 33 yearsHealthy volunteers can take part
- Conditions the study is for
- Weight Loss, Body Composition
- What is being tested?
- High Protein Diet Group and No High Protein Diet Group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteMexico
- Study dates
- 13 Jan 2020to 30 Jul 2021
- 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 20 to 33 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- individuals between the ages of 20 and 30
- who were not currently consuming any drugs or were on diet or exercise treatment.
- patients must have 120% or more of the ideal weight until a BMI of 35.
Who cannot join
- with no cardiovascular disease, kidney, intestinal or liver disease.
- cholesterol (≥ 200 mg/dL)
- high triglycerides (≥ 150mg/dL)
- glucose (≥ 126mg /dL)
Trial locations and contacts
1 site in 1 country.
Mexico1 site
Facultad de Organización Deportiva, FOD, Universidad Autónoma de Nuevo León
Monterrey, N.L., 64460
About this study
Official title: Effect of a Low-carbohydrate, High-protein Ketogenic Diet on Weight and Body Composition: a Randomized Controlled Study
People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. However, this diet is aggressive in its first phase because it suppresses carbohydrates, the main source of external energy being saturated low-fat protein. Studies of this diet are scarce and have been limited to describing the contribution of micronutrients. In nutritional practice, it is often assumed that a popular high-protein or low-calorie ketogenic diet could cause rapid or unfavourable changes in a patient's weight and body composition. However, the effect of these diets in the short or long term on weight and on body fat, muscle mass and other components is not clear. This means that body composition has not been the main objective when analyzing the effect of a popular diet. For this reason, the meta-analyzes focus on weight change and the absence of body composition data is a limitation of the selected studies. Changes in body composition due to a popular diet should be evaluated with techniques such as DXA. The aim of this study is to analyze the effect of a low-carbohydrate, high-protein diet with energy restriction on weight and body composition using DXA. For this, a randomized controlled study will be used where a group will receive the diet protocol. The control group will have a normal diet, and only one oatmeal drink will be added (55 g of oats in 250 ml of water). The drink will contain 1.6 g of BetaG per serving according to FDA recommendations that correspond to the 50% BetaG required per day.
Read the detailed description
The patients (n = 60) are invited through posters and social networks to recruit a group of 40 overweight subjects (20% above their ideal weight). The protocol is explained in detail to each one, and the patient and two witnesses sign the informed consent. Subjects are assigned to one of two groups: group A: high protein diet (HPD) and group B: non-high protein diet (NHPD). The NHPD is designed according to Mexican nutrition guidelines according to sex and age.
The main anthropometric and biochemical measurements and diet monitoring are performed in the body composition laboratory of the Faculty of Sports Organization (FOD). Four technicians (nutritionists) are in charge of taking the measurements and recording the data. The principal investigators review the quality of the information and the correct completion of the records. Each file will be assigned an identification number. Other nutritionists (graduate students) will be in charge of auditing the information according to the protocol guidelines. Principal Investigators will resolve any discrepancies between technicians and graduate students to ensure data recording, deletion, or reevaluation.
Each patient is asked for a prior medical examination before entering the study. The data from the external medical practitioner are compared with those provided by the patient for the present study.
The main anthropometric variables are measured with the international ISAK methodology. The DXA equipment is calibrated daily, and the result is analyzed and analyzed by a researcher who evaluates whether the measurement is reliable.
The data is recorded in printed formats that are immediately scanned to maintain readability. Later, they are recorded in an Excel sheet with the patient's identification number. In each measurement session, the database is analyzed for abnormal, extreme or unlikely data. Two independent researchers are responsible for reviewing the database every day.
Each patient is cared for by a nutrition student who accompanies him in the basic needs, clothing and transfers to the measurement equipment. At the end of the evaluation, patients receive a complimentary meal and free transportation home.
Patients are monitored through WhatsApp to verify the presence of adverse events with the diet. Also, for any questions with the procedures. All procedures are recorded in paper and electronic form. In addition, they are given an additional number in case of medical emergency or consultation with a nutritionist.
The sample size will be limited in the first stage to 30 patients. Measurements and preliminary analysis will be obtained at 0, day four and day fifteen. The last two measurements will be taken on day 42 and until the subjects reach their ideal body weight.
In the case of missing data or defective quality record, subjects will be removed.
Regarding the statistical analysis, multiple linear regression will be used, where the groups and measurements will be compared on the different measurement days. As covariates, covariates will be incorporated as initial values, age, sex, BMI, among others, will be adjusted. Descriptive statistics will be added.
- Conditions
- Weight Loss, Body Composition
- Being tested
- High Protein Diet Group, No High Protein Diet Group
- Medical subject headings
- Weight Loss
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High Protein Diet GroupOther
The high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. This diet has 4 phases, two of weight loss until reaching the ideal weight (attack and cruise) and two of maintenance (consolidation and stabilization). During the first 2 phases, it allows 100 foods (28 vegetables). The first phase lasts 3-10 days and 72 high-protein, low-fat foods are allowed. In the second phase, there are alternate days between consuming the low glycemic index vegetables plus protein and the next day with just protein. The first two phases are ad libitum. Phase 3 (consolidation) aims to avoid rebound and begins the introduction of complex carbohydrates and legumes in individual servings. In phase 4 (stabilization), the subject returns to a free diet. However, three basic rules are introduced: protein one day a week, the exercise of at least 20 min/day (optional) and consumption of 3 tablespoons of oat bran/day.
No High Protein Diet GroupOther
No high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. Beverage contained 1.6 g of betaG per portion according to FDA recommendations corresponding to 50 % of betaG required per day. Weekly bags containing oat mixture were provided on day 0 and in the third week of the trial. No additional instructions about diet, exercise program or pharmacological treatment was implemented.
| Study group | Role | What they receive |
|---|---|---|
| High Protein Diet Group | Experimental | The high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. Receives: Other: High Protein Diet Group |
| No High Protein Diet Group | Active comparator | No high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. Receives: Other: No High Protein Diet Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Body fat
Body fat measurements by DXA
Measured: Baseline to three months.
Lean mass
Lean mass measurements by DXA
Measured: Baseline to three months
Weight lost
Weight lost through the various phases
Measured: Baseline to three months
Secondary outcomes (14)
Body water
Body water changes measured by bioelectrical impedance
Measured: Baseline to three months
Resting energy expenditure
Energy expenditure measure by calorimetry.
Measured: Baseline to three months
Caloric and macronutrient intake
Energy and macronutrient distribution intake. To estimate the nutrient intake is used as a weighted dietary record. Each individual weighs the items on a scale before and after consumption by three consecutive days. Scales has a precision of 1 g. The persons record all the food and beverages consumed, including ingredients, preparation method, and quantity of the food consumed and not consumed. We proportionate all the instruction and description for the individual before assigning the task to record. This procedure ensures the accuracy and reliability of the information provided. Records are processed with the software DietOrganizer (R) to obtain caloric and macronutrient intake.
Measured: Baseline to three months
Serum fasting triglycerides
Serum fasting triglicerides are taken after 9 to 12 h, milligrams per deciliter (mg/dL).
Measured: Baseline to three months
Serum fasting glucose
Serum fasting glucose is taken after 9 to 12 h, milligrams per deciliter (mg/dL).
Measured: Baseline to three months
Serum fasting total cholesterol
Serum total cholesterol is taken after 9 to 12 h, milligrams per deciliter (mg/dL).
Measured: Baseline to three months
Serum fasting HDL cholesterol
Serum total cholesterol is taken after 9 to 12 h, milligrams per deciliter (mg/dL).
Measured: Baseline to three months
Serum fasting albumin
Serum total cholesterol is taken after 9 to 12 h, grams per deciliter (g/dL).
Measured: Baseline to three months
Serum fasting total protein
Serum total cholesterol is taken after 9 to 12 h, grams per deciliter (g/dL).
Measured: Baseline to three months
Serum fasting total hemoglobin
Serum total cholesterol is taken after 9 to 12 h, grams per deciliter (g/dL).
Measured: Baseline to three months
hand strenght with a dynamometer
Hand strength is measured with a standardized protocol using a chair. A digital dynamometer is employed, and units are expressed as kg.
Measured: Baseline to three months
triceps skinfold with a plicometer
triceps skinfold is measured with a plicometer and the units are expresed as mm
Measured: Baseline to three months
waist perimeter
waist perimeter is measured with a measuring tape and units are expresed as cm
Measured: Baseline to three months
mid-arm perimeter
mid arm perimeter is measured with a measuring tape and units are expresed as cm
Measured: Baseline to three months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Nov 2020
- Study start13 Jan 2020
- Primary completion9 May 2020
- Study completion30 Jul 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Weight LossStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This is a randomized controlled clinical study. Subjects are assigned to one of two groups: the intervention group (group A or high protein diet or HPD) and the group without high protein diet or NHPD. The assignment is done with the use of MedCalc software and the option to create random groups. Both groups are treated equally except for the procedure or diet. The blind or double-blind procedure is not used in this study. Both groups are treated during the same study period. The maximum number of patients to be evaluated per day will be three. Patients are not mixed from one group or another in each evaluation.
- Masking
- None (open label)
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Erik Ramirez Lopez
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Erik Ramirez Lopez, Universidad Autonoma de Nuevo Leon
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04646733
- Sponsor's protocol ID
- erik2020DUKAN
- Other IDs
- REPRIN-FOD-76
- Status last verified
- Dec 2023
- First submitted
- 13 Nov 2020
- Last updated
- 19 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Anton SD, Hida A, Heekin K, Sowalsky K, Karabetian C, Mutchie H, Leeuwenburgh C, Manini TM, Barnett TE. Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials. Nutrients. 2017 Jul 31;9(8):822. doi: 10.3390/nu9080822.
PubMed 28758964Atallah R, Filion KB, Wakil SM, Genest J, Joseph L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. Long-term effects of 4 popular diets on weight loss and cardiovascular risk factors: a systematic review of randomized controlled trials. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):815-27. doi: 10.1161/CIRCOUTCOMES.113.000723. Epub 2014 Nov 11.
PubMed 25387778Seid H, Rosenbaum M. Low Carbohydrate and Low-Fat Diets: What We Don't Know and Why we Should Know It. Nutrients. 2019 Nov 12;11(11):2749. doi: 10.3390/nu11112749.
PubMed 31726791
Study at a glance
From the registry record, last updated by the sponsor on 19 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of a Low-carbohydrate, High-protein Ketogenic Diet on Weight and Body Composition: a Randomized Controlled Study
- ClinicalTrials.gov ID
- NCT04646733
- Acronym / sponsor ID
- erik2020DUKAN
- Conditions
- Weight Loss, Body Composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Erik Ramirez LopezUniversity, hospital or other
- Study start
- 13 Jan 2020 (actual)
- Primary completion
- 9 May 2020 (actual)
- Study completion
- 30 Jul 2021 (actual)
- First posted
- 30 Nov 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.
People often choose certain diets to lose weight or to change their habits or lifestyle. The Dukan diet was created in the '70s and took on importance in the last decade. It is a 4 phase diet similar to the Atkins diet. However, this diet is aggressive in its first phase because it suppresses carbohydrates, the main source of external energy being saturated low-fat protein. Studies of this diet are scarce and have been limited to describing the contribution of micronutrients. In nutritional practice, it is often assumed that a popular high-protein or low-calorie ketogenic diet could cause rapid or unfavourable changes in a patient's weight and body composition. However, the effect of these diets in the short or long term on weight and on body fat, muscle mass and other components is not clear. This means that body composition has not been the main objective when analyzing the effect of a popular diet. For this reason, the meta-analyzes focus on weight change and the absence of body composition data is a limitation of the selected studies. Changes in body composition due to a popular diet should be evaluated with techniques such as DXA. The aim of this study is to analyze the effect of a low-carbohydrate, high-protein diet with energy restriction on weight and body composition using DXA. For this, a randomized controlled study will be used where a group will receive the diet protocol. The control group will have a normal diet, and only one oatmeal drink will be added (55 g of oats in 250 ml of water). The drink will contain 1.6 g of BetaG per serving according to FDA recommendations that correspond to the 50% BetaG required per day.
Detailed description
The patients (n = 60) are invited through posters and social networks to recruit a group of 40 overweight subjects (20% above their ideal weight). The protocol is explained in detail to each one, and the patient and two witnesses sign the informed consent. Subjects are assigned to one of two groups: group A: high protein diet (HPD) and group B: non-high protein diet (NHPD). The NHPD is designed according to Mexican nutrition guidelines according to sex and age.
The main anthropometric and biochemical measurements and diet monitoring are performed in the body composition laboratory of the Faculty of Sports Organization (FOD). Four technicians (nutritionists) are in charge of taking the measurements and recording the data. The principal investigators review the quality of the information and the correct completion of the records. Each file will be assigned an identification number. Other nutritionists (graduate students) will be in charge of auditing the information according to the protocol guidelines. Principal Investigators will resolve any discrepancies between technicians and graduate students to ensure data recording, deletion, or reevaluation.
Each patient is asked for a prior medical examination before entering the study. The data from the external medical practitioner are compared with those provided by the patient for the present study.
The main anthropometric variables are measured with the international ISAK methodology. The DXA equipment is calibrated daily, and the result is analyzed and analyzed by a researcher who evaluates whether the measurement is reliable.
The data is recorded in printed formats that are immediately scanned to maintain readability. Later, they are recorded in an Excel sheet with the patient's identification number. In each measurement session, the database is analyzed for abnormal, extreme or unlikely data. Two independent researchers are responsible for reviewing the database every day.
Each patient is cared for by a nutrition student who accompanies him in the basic needs, clothing and transfers to the measurement equipment. At the end of the evaluation, patients receive a complimentary meal and free transportation home.
Patients are monitored through WhatsApp to verify the presence of adverse events with the diet. Also, for any questions with the procedures. All procedures are recorded in paper and electronic form. In addition, they are given an additional number in case of medical emergency or consultation with a nutritionist.
The sample size will be limited in the first stage to 30 patients. Measurements and preliminary analysis will be obtained at 0, day four and day fifteen. The last two measurements will be taken on day 42 and until the subjects reach their ideal body weight.
In the case of missing data or defective quality record, subjects will be removed.
Regarding the statistical analysis, multiple linear regression will be used, where the groups and measurements will be compared on the different measurement days. As covariates, covariates will be incorporated as initial values, age, sex, BMI, among others, will be adjusted. Descriptive statistics will be added.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- This is a randomized controlled clinical study. Subjects are assigned to one of two groups: the intervention group (group A or high protein diet or HPD) and the group without high protein diet or NHPD. The assignment is done with the use of MedCalc software and the option to create random groups. Both groups are treated equally except for the procedure or diet. The blind or double-blind procedure is not used in this study. Both groups are treated during the same study period. The maximum number of patients to be evaluated per day will be three. Patients are not mixed from one group or another in each evaluation.
| Arm | Type | Receives |
|---|---|---|
| High Protein Diet Group | Experimental | Other: High Protein Diet GroupThe high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. |
| No High Protein Diet Group | Active comparator | Other: No High Protein Diet GroupNo high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. |
Who may qualify
- Ages
- 20 to 33 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- individuals between the ages of 20 and 30
- who were not currently consuming any drugs or were on diet or exercise treatment.
- patients must have 120% or more of the ideal weight until a BMI of 35.
Key exclusion criteria (4 listed)
- with no cardiovascular disease, kidney, intestinal or liver disease.
- cholesterol (≥ 200 mg/dL)
- high triglycerides (≥ 150mg/dL)
- glucose (≥ 126mg /dL)
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 |
|---|---|---|
| High Protein Diet GroupThe high protein diet (HPD) group is instructed to follow a low carbohydrate, high protein ketogenic diet. This diet has 4 phases, two of weight loss until reaching the ideal weight (attack and cruise) and two of maintenance (consolidation and stabilization). During the first 2 phases, it allows 100 foods (28 vegetables). The first phase lasts 3-10 days and 72 high-protein, low-fat foods are allowed. In the second phase, there are alternate days between consuming the low glycemic index vegetables plus protein and the next day with just protein. The first two phases are ad libitum. Phase 3 (consolidation) aims to avoid rebound and begins the introduction of complex carbohydrates and legumes in individual servings. In phase 4 (stabilization), the subject returns to a free diet. However, three basic rules are introduced: protein one day a week, the exercise of at least 20 min/day (optional) and consumption of 3 tablespoons of oat bran/day. | Other | High Protein Diet Group |
| No High Protein Diet GroupNo high protein diet (NHPD) group received an oat beverage consisted of 55 g of oats in 250 ml of water. Beverage contained 1.6 g of betaG per portion according to FDA recommendations corresponding to 50 % of betaG required per day. Weekly bags containing oat mixture were provided on day 0 and in the third week of the trial. No additional instructions about diet, exercise program or pharmacological treatment was implemented. | Other | No High Protein Diet Group |
Primary outcome
Body fat
Time frame: Baseline to three months.
Body fat measurements by DXA
Lean mass
Time frame: Baseline to three months
Lean mass measurements by DXA
Weight lost
Time frame: Baseline to three months
Weight lost through the various phases
14 secondary outcomes
Body water
Time frame: Baseline to three months
Resting energy expenditure
Time frame: Baseline to three months
Caloric and macronutrient intake
Time frame: Baseline to three months
Serum fasting triglycerides
Time frame: Baseline to three months
Serum fasting glucose
Time frame: Baseline to three months
Serum fasting total cholesterol
Time frame: Baseline to three months
Serum fasting HDL cholesterol
Time frame: Baseline to three months
Serum fasting albumin
Time frame: Baseline to three months
Serum fasting total protein
Time frame: Baseline to three months
Serum fasting total hemoglobin
Time frame: Baseline to three months
hand strenght with a dynamometer
Time frame: Baseline to three months
triceps skinfold with a plicometer
Time frame: Baseline to three months
waist perimeter
Time frame: Baseline to three months
mid-arm perimeter
Time frame: Baseline to three months
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 19 Dec 2023.
- Background: PubMed 28758964Anton SD, Hida A, Heekin K, Sowalsky K, Karabetian C, Mutchie H, Leeuwenburgh C, Manini TM, Barnett TE. Effects of Popular Diets without Specific Calorie Targets on Weight Loss Outcomes: Systematic Review of Findings from Clinical Trials. Nutrients. 2017 Jul 31;9(8):822. doi: 10.3390/nu9080822.
- Background: PubMed 25387778Atallah R, Filion KB, Wakil SM, Genest J, Joseph L, Poirier P, Rinfret S, Schiffrin EL, Eisenberg MJ. Long-term effects of 4 popular diets on weight loss and cardiovascular risk factors: a systematic review of randomized controlled trials. Circ Cardiovasc Qual Outcomes. 2014 Nov;7(6):815-27. doi: 10.1161/CIRCOUTCOMES.113.000723. Epub 2014 Nov 11.
- Background: PubMed 31726791Seid H, Rosenbaum M. Low Carbohydrate and Low-Fat Diets: What We Don't Know and Why we Should Know It. Nutrients. 2019 Nov 12;11(11):2749. doi: 10.3390/nu11112749.
- 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 High Protein Diet Group and No High Protein Diet Group in people with Weight Loss and Body Composition, run by Erik Ramirez Lopez at 1 site in Mexico.
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 4 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 19 Dec 2023. 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 Mexico. 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 fat (time frame: Baseline to three months.). The study lists 3 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 NCT04646733, which also lists 3 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 19 Dec 2023.