Composition and Function of the Gut Microbiota Post InterventionNCT05237154
Intermittent Fasting and Exercise: Effects on Gut Microbiota, Body Composition and Inflammation.
A study testing Intervention with intermittent fasting. and Intervention with high-intensity interval training. in people with Composition and Function of the Gut Microbiota Post Intervention and Metabolic and Inflammatory Variables Post Intervention, run by University of Sao Paulo at 2 sites in Brazil.
Trial summary
Obesity and overweight affect around 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Composition and Function of the Gut Microbiota Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- What is being tested?
- Intervention with intermittent fasting. and Intervention with high-intensity interval training.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 2 sitesBrazil
- Study dates
- 1 Jul 2018to 30 Jan 2019
- 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 40 years
- Women only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Age between 18 and 40 years;
- Women;
- Have a regular menstrual cycle;
- Body weight below 120 kg;
- BMI between 30 kg/m2 and 40 kg/m2.
Who cannot join
- Individuals with any disease;
- Smokers;
- Alcoholics;
- Use regular medication;
- Medical impediment to the practice of physical activities;
- Carry out nutritional monitoring;
- Being in treatment for weight loss;
- Present some discomfort in long periods of fasting.
Trial locations and contacts
2 sites in 1 country.
Brazil2 sites
University of São Paulo, School of Physical Education and Sports of Ribeirão Preto.
Ribeirão Preto, São Paulo, 14049-900
Gabriela Batitucci
Ribeirão Preto, São Paulo
About this study
Official title: Secondary Effects of Intermittent Fasting and Physical Exercise on the Modulation of the Gut Microbiota, Body Composition and Inflammatory Process in Obesity.
Obesity and overweight affect around 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity.
Read the detailed description
Background: Obesity and overweight affect about 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity. Methods: 60 obese women will participate in the study and will be randomly divided into 3 groups: 1) the intermittent fasting group, submitted to a diet for 8 weeks (n= 20); 2) the physical exercise group, submitted to physical training for 8 weeks (n= 20); and 3) intermittent fasting group associated with physical exercise, submitted to both interventions for 8 weeks (n= 20). All volunteers will perform collections and evaluations (pre and post intervention) of anthropometry, food consumption, indirect calorimetry to assess resting energy expenditure, body composition by BodPod®, blood collection for biochemical analysis and gene expression, collection of feces for the analysis of the intestinal microbiota and physical tests (Shuttle Walking Test, multiple repetition test and functional strength) for the exercise groups. Expected results: The synergistic effects of the proposed intervention are expected to improve gut microbiota and metabolic parameters in obese women.
- Conditions
- Composition and Function of the Gut Microbiota Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- Being tested
- Intervention with intermittent fasting., Intervention with high-intensity interval training.
- Keywords
- Obesity, Gut microbiota, Intermittent fasting, High-intensity interval training, Metataxononic, Body composition
- Medical subject headings
- Obesity, Intermittent Fasting
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intervention with intermittent fasting.Other
Also called IF
Intervention with fasting protocol of alternate days 2 days a week and the other days with ad libitum consumption. Restricted food in 25% of the total daily needs on the days of the intermittent fasting protocol, with 18 hours of fasting and 6 hours of restricted feeding (18:6).
Intervention with high-intensity interval training.Other
Also called HIIT
Intervention with high-intensity interval training, 3x per week, with intensity maintained between 70-85% of maximum heart rate.
| Study group | Role | What they receive |
|---|---|---|
| Intermittent fasting (IF) | Experimental | Alternate-day intermittent fasting. Consumption of 25% of daily energy requirements on scheduled fasting days involving energy restriction for 2 non-consecutive days of the week and ad libitum feeding on the other 5 days of the week. Period: 8 weeks. Receives: Other: Intervention with intermittent fasting. |
| Exercise: High-Intensity Interval Training (HIIT) | Experimental | High intensity circuit training. Progressive training protocol 3x/week, for 8 weeks, with at least 1 day of rest between sessions and duration of 25 minutes each session - 4 minutes of initial warm-up, 18 minutes of the main part and 3 minutes of relaxation. First and second week: 30 second run and recovery time. Third and fourth week: 35-second runtime and 25-second recovery time. Fifth and Sixth Week: 40-second runtime and 20-second recovery time. Seventh and eighth weeks: 45-second runtime and 15-second recovery time. Receives: Other: Intervention with high-intensity interval training. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Anthropometric changes (Body weight)
Changes in body weight (kilograms - Kg) pre and post intervention.
Measured: eight weeks
Anthropometric - height assessment (meters)
Height measured in meters
Measured: eight weeks
Anthropometric changes (BMI)
Changes in body mass index (evaluated through a calculation that combines weight measured in kilograms divided by height in meters squared - BMI in kg/m^2) evaluated pre and post intervention.
Measured: eight weeks
Anthropometric changes (Circumferences)
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Measured: eight weeks
Body composition changes
Changes in fat-free mass and fat mass evaluated pre and post intervention by whole-body air displacement plethysmography method, BodPod® .
Measured: eight weeks
Dietary intake changes
Completion of the food record of three non-consecutive days, one day of the week that included the intermittent fasting protocol, another day of the week with ad libitum and a weekend day. This evaluation will take place pre-intervention, in the fourth week and after the intervention. Assessment of caloric intake, macronutrients and fiber evaluated pre and post intervention (Dietwin® software - São Paulo, Brazil).
Measured: eight weeks
Indirect calorimetry assessment
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Measured: eight weeks
Indirect calorimetry assessment (energetic substrates)
Changes in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry.
Measured: eight weeks
Changes in total cholesterol and lipid fractions
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c evaluated pre and post intervention, quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer.
Measured: eight weeks
Changes in plasma cytokines
Changes in serum levels of cytokines IL-15, IL-10, TNF-α adiponectin, resistin, adipsin/Factor D, fetuin-A and C-reactive protein evaluated pre and post intervention, by MILLIPLEX® Kit.
Measured: eight weeks
Changes in nitrogen balance
Determination of urinary nitrogen by chemiluminescence method. 24-hour urine analysis evaluated pre and post intervention. Calculation of nitrogen balance by a equation.
Measured: eight weeks
Changes in concentration of short-chain fatty acids (acetate, propionate, and butyrate)
Quantification of short-chain fatty acids using stool samples, evaluated pre and post intervention, by gas chromatography method.
Measured: eight weeks
Changes in gut microbiota_Extraction and DNA sequencing and library preparation.
Total fecal DNA extraction using the QIAamp 96 PowerFecal kit (Mobio-QIAGEN). Regions of interest V2-V3, V3-V4 and V4-V5 present in the extracted total DNA. Amplification and preparation of libraries according to the Illumina® kit protocol. 16S sequencing by Illumina® company's MiSeq platform. Metataxonomic analysis of 16S rDNA sequences by bioinformatics. Assessments analyzed pre and post intervention.
Measured: eight weeks
Changes in aerobic performance
Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.
Measured: eight weeks
Changes in strength performance
Maximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press.
Measured: eight weeks
Changes in strength performance
Assessment of changes in maximal isometric muscle strength of the dorsal region and handgrip by dynamometry.
Measured: eight weeks
Changes in strength performance
Strength endurance capacity by 1-minute functional tests (squat, free squat and push-up).
Measured: eight weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Feb 2022
- Study start1 Jul 2018
- Primary completion15 Dec 2018
- Study completion30 Jan 2019
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Composition and Function of the Gut Microbiota Post InterventionStudies 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
- Randomized clinical trial.
- Masking
- None (open label)
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Sao Paulo
- Sponsor type
- University, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Responsible party
- Principal investigator, Ellen Cristini de Freitas, University of Sao Paulo
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05237154
- Sponsor's protocol ID
- Gut Microbiota-Obesity
- Status last verified
- Feb 2022
- First submitted
- 20 Jan 2022
- Last updated
- 11 Feb 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Batitucci G, Almeida OG, De Martinis ECP, Solar I, Cintra DE, de Freitas EC. Intermittent fasting and high-intensity interval training do not alter gut microbiota composition in adult women with obesity. Am J Physiol Endocrinol Metab. 2024 Sep 1;327(3):E241-E257. doi: 10.1152/ajpendo.00310.2023. Epub 2024 Jun 26.
PubMed 38922577Batitucci G, Faria Junior EV, Nogueira JE, Brandao CFC, Abud GF, Ortiz GU, Marchini JS, Freitas EC. Impact of Intermittent Fasting Combined With High-Intensity Interval Training on Body Composition, Metabolic Biomarkers, and Physical Fitness in Women With Obesity. Front Nutr. 2022 May 26;9:884305. doi: 10.3389/fnut.2022.884305. eCollection 2022.
PubMed 35694163
Study at a glance
From the registry record, last updated by the sponsor on 11 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Secondary Effects of Intermittent Fasting and Physical Exercise on the Modulation of the Gut Microbiota, Body Composition and Inflammatory Process in Obesity.
- ClinicalTrials.gov ID
- NCT05237154
- Acronym / sponsor ID
- Gut Microbiota-Obesity
- Conditions
- Composition and Function of the Gut Microbiota Post Intervention, Metabolic and Inflammatory Variables Post Intervention
- Keywords
- Obesity, Gut microbiota, Intermittent fasting, High-intensity interval training, Metataxononic, Body composition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- University of Sao PauloUniversity, hospital or other
- Collaborators
- Fundação de Amparo à Pesquisa do Estado de São Paulo, Coordenação de Aperfeiçoamento de Pessoal de Nível Superior.
- Study start
- 1 Jul 2018 (actual)
- Primary completion
- 15 Dec 2018 (actual)
- Study completion
- 30 Jan 2019 (actual)
- First posted
- 11 Feb 2022 (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.
Obesity and overweight affect around 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity.
Detailed description
Background: Obesity and overweight affect about 2 billion people worldwide. Despite the growing prevalence, the treatment of obesity is still an obscure field and the impacts of this disease on the clinical and public health perspective are urgent. Studies have demonstrated a fundamental role of the gut microbiota in the pathogenesis of obesity and discuss the impacts of diet and physical exercise on the microbiome profile. However, the mechanisms involved in these processes, referring to strategies such as intermittent fasting associated with physical training, are still poorly explored and understood. It is believed that intermittent fasting combined with physical exercise can promote a remodeling of the composition and function of the microbiota and that the present investigation is promising in the prevention and treatment of obesity. Methods: 60 obese women will participate in the study and will be randomly divided into 3 groups: 1) the intermittent fasting group, submitted to a diet for 8 weeks (n= 20); 2) the physical exercise group, submitted to physical training for 8 weeks (n= 20); and 3) intermittent fasting group associated with physical exercise, submitted to both interventions for 8 weeks (n= 20). All volunteers will perform collections and evaluations (pre and post intervention) of anthropometry, food consumption, indirect calorimetry to assess resting energy expenditure, body composition by BodPod®, blood collection for biochemical analysis and gene expression, collection of feces for the analysis of the intestinal microbiota and physical tests (Shuttle Walking Test, multiple repetition test and functional strength) for the exercise groups. Expected results: The synergistic effects of the proposed intervention are expected to improve gut microbiota and metabolic parameters in obese women.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized clinical trial.
| Arm | Type | Receives |
|---|---|---|
| Intermittent fasting (IF) | Experimental | Other: Intervention with intermittent fasting.Alternate-day intermittent fasting. Consumption of 25% of daily energy requirements on scheduled fasting days involving energy restriction for 2 non-consecutive days of the week and ad libitum feeding on the other 5 days of the week. Period: 8 weeks. |
| Exercise: High-Intensity Interval Training (HIIT) | Experimental | Other: Intervention with high-intensity interval training.High intensity circuit training. Progressive training protocol 3x/week, for 8 weeks, with at least 1 day of rest between sessions and duration of 25 minutes each session - 4 minutes of initial warm-up, 18 minutes of the main part and 3 minutes of relaxation. First and second week: 30 second run and recovery time. Third and fourth week: 35-second runtime and 25-second recovery time. Fifth and Sixth Week: 40-second runtime and 20-second recovery time. Seventh and eighth weeks: 45-second runtime and 15-second recovery time. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age between 18 and 40 years;
- Women;
- Have a regular menstrual cycle;
- Body weight below 120 kg;
- BMI between 30 kg/m2 and 40 kg/m2.
Key exclusion criteria (8 listed)
- Individuals with any disease;
- Smokers;
- Alcoholics;
- Use regular medication;
- Medical impediment to the practice of physical activities;
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 |
|---|---|---|
| Intervention with intermittent fasting.Also: IFIntervention with fasting protocol of alternate days 2 days a week and the other days with ad libitum consumption. Restricted food in 25% of the total daily needs on the days of the intermittent fasting protocol, with 18 hours of fasting and 6 hours of restricted feeding (18:6). | Other | Intermittent fasting (IF) |
| Intervention with high-intensity interval training.Also: HIITIntervention with high-intensity interval training, 3x per week, with intensity maintained between 70-85% of maximum heart rate. | Other | Exercise: High-Intensity Interval Training (HIIT) |
Primary outcome
Anthropometric changes (Body weight)
Time frame: eight weeks
Changes in body weight (kilograms - Kg) pre and post intervention.
Anthropometric - height assessment (meters)
Time frame: eight weeks
Height measured in meters
Anthropometric changes (BMI)
Time frame: eight weeks
Changes in body mass index (evaluated through a calculation that combines weight measured in kilograms divided by height in meters squared - BMI in kg/m^2) evaluated pre and post intervention.
Anthropometric changes (Circumferences)
Time frame: eight weeks
Changes in waist, abdominal, and hip circumferences (centimeters) evaluated pre and post intervention.
Body composition changes
Time frame: eight weeks
Changes in fat-free mass and fat mass evaluated pre and post intervention by whole-body air displacement plethysmography method, BodPod® .
Dietary intake changes
Time frame: eight weeks
Completion of the food record of three non-consecutive days, one day of the week that included the intermittent fasting protocol, another day of the week with ad libitum and a weekend day. This evaluation will take place pre-intervention, in the fourth week and after the intervention. Assessment of caloric intake, macronutrients and fiber evaluated pre and post intervention (Dietwin® software - São Paulo, Brazil).
Indirect calorimetry assessment
Time frame: eight weeks
Changes in resting metabolic rate (RMR) evaluated pre and post intervention by indirect calorimetry.
Indirect calorimetry assessment (energetic substrates)
Time frame: eight weeks
Changes in oxidation of substrates (lipids and carbohydrates) evaluated pre and post intervention by indirect calorimetry.
Changes in total cholesterol and lipid fractions
Time frame: eight weeks
Changes in total cholesterol, triglycerides, HDL-cholesterol and LDL-c evaluated pre and post intervention, quantified by Total Liquiform Cholesterol Kit, HDL Cholesterol Kit and Liquiform Triglycerides Kit, from Labtest diagnóstica®, using an enzymatic system and absorbance spectrophotometer.
Changes in plasma cytokines
Time frame: eight weeks
Changes in serum levels of cytokines IL-15, IL-10, TNF-α adiponectin, resistin, adipsin/Factor D, fetuin-A and C-reactive protein evaluated pre and post intervention, by MILLIPLEX® Kit.
Changes in nitrogen balance
Time frame: eight weeks
Determination of urinary nitrogen by chemiluminescence method. 24-hour urine analysis evaluated pre and post intervention. Calculation of nitrogen balance by a equation.
Changes in concentration of short-chain fatty acids (acetate, propionate, and butyrate)
Time frame: eight weeks
Quantification of short-chain fatty acids using stool samples, evaluated pre and post intervention, by gas chromatography method.
Changes in gut microbiota_Extraction and DNA sequencing and library preparation.
Time frame: eight weeks
Total fecal DNA extraction using the QIAamp 96 PowerFecal kit (Mobio-QIAGEN). Regions of interest V2-V3, V3-V4 and V4-V5 present in the extracted total DNA. Amplification and preparation of libraries according to the Illumina® kit protocol. 16S sequencing by Illumina® company's MiSeq platform. Metataxonomic analysis of 16S rDNA sequences by bioinformatics. Assessments analyzed pre and post intervention.
Changes in aerobic performance
Time frame: eight weeks
Physical tests performed pre and post intervention to assess aerobic physical fitness by incremental test adapted from Shuttle Walking.
Changes in strength performance
Time frame: eight weeks
Maximum dynamic muscular strength by test of multiple maximum repetitions (RM) in the leg press 45° and in the bench press.
Changes in strength performance
Time frame: eight weeks
Assessment of changes in maximal isometric muscle strength of the dorsal region and handgrip by dynamometry.
Changes in strength performance
Time frame: eight weeks
Strength endurance capacity by 1-minute functional tests (squat, free squat and push-up).
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 11 Feb 2022.
- Derived from this study: PubMed 38922577Batitucci G, Almeida OG, De Martinis ECP, Solar I, Cintra DE, de Freitas EC. Intermittent fasting and high-intensity interval training do not alter gut microbiota composition in adult women with obesity. Am J Physiol Endocrinol Metab. 2024 Sep 1;327(3):E241-E257. doi: 10.1152/ajpendo.00310.2023. Epub 2024 Jun 26.
- Derived from this study: PubMed 35694163Batitucci G, Faria Junior EV, Nogueira JE, Brandao CFC, Abud GF, Ortiz GU, Marchini JS, Freitas EC. Impact of Intermittent Fasting Combined With High-Intensity Interval Training on Body Composition, Metabolic Biomarkers, and Physical Fitness in Women With Obesity. Front Nutr. 2022 May 26;9:884305. doi: 10.3389/fnut.2022.884305. eCollection 2022.
- Individual participant dataSharing planned: No
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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intervention with intermittent fasting. and Intervention with high-intensity interval training. in people with Composition and Function of the Gut Microbiota Post Intervention and Metabolic and Inflammatory Variables Post Intervention, run by University of Sao Paulo at 2 sites in Brazil.
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 8 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 11 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Brazil. 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?
Anthropometric changes (Body weight) (time frame: eight weeks). The study lists 17 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 NCT05237154, which also lists 2 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 11 Feb 2022.