Overweight and ObesityMIND-EATNCT06157411
Adapting Mindful Eating Program for French Overweight/Obese Population
A study testing Mindful Eating Intervention (AC group) and Conventional Dietetic Intervention (DC group) in people with Overweight and Obesity, run by University Hospital, Montpellier at 1 site in France.
Trial summary
The aim of this project is to validate a new mindful eating programme adapted to the overweight or obese French population. Recognising the importance of diet in the management of chronic diseases, particularly obesity, and the limitations of traditional weight management approaches, the study focuses on the… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Overweight and Obesity
- What is being tested?
- Mindful Eating Intervention (AC group) and Conventional Dietetic Intervention (DC group)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 56 participants
- Where
- 1 siteFrance
- Study dates
- 16 Feb 2024to 10 Jan 2025
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- First visit to the Nutrition and Diabetes Unit of Montpellier University Hospital for overweight/obesity
- Adults aged 18 and over, volunteers
- BMI ≥ 25kg/m² and ≤ 50kg/m²
- Provisional verbal consent followed by signed written consent
Who cannot join
- People who are illiterate or suffer from a major cognitive impairment that prevents them from understanding the study and the mindful eating program
- Pregnant or breast-feeding women
- People who are taking medicines that may have an effect on their weight (especially GLP-1 analogs, neuroleptics, corticosteroids)
- Anyone with a history of bariatric surgery or scheduled bariatric surgery within the next 6 months
- Presence of co-morbidities or severe pathologies (in particular respiratory failure, heart failure, cancer)
- Diagnosis of severe psychiatric disorder (in particular schizophrenia, bipolar disorder), depressive syndrome, or suicidal behavior in the past year
Show all 9Show fewer
- People suffering from genetic or syndromic obesity
- Lack of Internet access
- Person currently participating in another interventional study
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Validation of a Mindful Eating Program Adapted to the French Population Living With Overweight or Obesity
The aim of this project is to validate a new mindful eating programme adapted to the overweight or obese French population. Recognising the importance of diet in the management of chronic diseases, particularly obesity, and the limitations of traditional weight management approaches, the study focuses on the application of mindful eating. The investigators have adapted a model based on an existing eating disorders programme overseas, taking into account feedback from participants in a qualitative study and the scientific literature. The ultimate aim is to test and validate the effectiveness of this new programme in improving the care of overweight or obese French adults, thereby filling a gap in interventions for this population in France.
Read the detailed description
This research will take the form of a single-center, randomized, two-arm trial comparing a mindful eating intervention (AC group) with a conventional dietary intervention (DC group). The investigators plan to enroll 56 patients who will be randomized to these two groups with stratification based on gender, age (<45, >=45), and BMI (25-30, >30). Randomization will be performed by minimization.
Participants in the AC group (N=28) will follow a program led by an instructor trained in nutrition and mindfulness, incorporating the Alberts program adapted for the overweight or obese population. For 8 consecutive weeks, comprising one 2-hour group session per week at Montpellier University Hospital and individual exercises at home.
Participants in the DC group (N=28) will follow the standard weight management program normally offered by the Nutrition - Diabetes Unit of the Montpellier University Hospital.
This research also includes a qualitative study for the AC group, based on focus groups set up after the end of the mindful eating program.
Participants will be recruited from all consecutive overweight or obese patients attending the Nutrition and Diabetes Unit of the University Hospital of Montpellier who have not yet been enrolled in the therapeutic education program. The unit sees over 1,000 patients a year who meet the criteria for this study.
- Conditions
- Overweight and Obesity
- Being tested
- Mindful Eating Intervention (AC group), Conventional Dietetic Intervention (DC group)
- Keywords
- Mindful eating, Mindfulness, Validation program, Mixed methods
- Medical subject headings
- Overweight, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Mindful Eating Intervention (AC group)Behavioural
Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist.
Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups.
Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform.
Mindful eating program: group sessions one evening a week (8x2h) and home exercises (30 min/day).
Visit 2: visit identical to visit 1
Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations.
Visit 3: visit identical to visit 1
Focus groups: Each participant will be asked to describe the program and talk about their perceptions and feelings, as well as the potential changes in behavior they have observed in their daily life.
Conventional Dietetic Intervention (DC group)Behavioural
Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist.
Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups.
Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform.
Visit 2: visit identical to visit 1
Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations.
Visit 3: visit identical to visit 1
| Study group | Role | What they receive |
|---|---|---|
| Mindful Eating Intervention (AC group) | Experimental | * Mindful eating program: Two sub-groups of 14 participants will follow the program for 8 consecutive weeks.
* Follow-up group session: The two groups of 14 participants will each attend a follow-up group session.
* 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program.
* Focus groups: The two groups of 14 participants will be divided into two (N=7, x4) for a focus group session. Receives: Behavioral: Mindful Eating Intervention (AC group) |
| Conventional Dietetic Intervention (DC group) | Active comparator | * Therapeutic education program (ETP): The 28 participants will follow the ETP program "Obesity: living better, balancing my weight".
* Follow-up group session: The 28 participants will have an individual follow-up session in the form of a final Shared Educational Assessment.
* 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program. Receives: Behavioral: Conventional Dietetic Intervention (DC group) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Variation in the level of mindful eating.
It will be measured by the Mind-Eat Scale questionnaire. The Mind-Eat Scale is the first questionnaire to provide a total score of the level of mindful eating and is available in French. This questionnaire was developed and validated as part of the Mind-eat project led by our research team, and the corresponding scientific publication is currently being published.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Secondary outcomes (8)
Variation in anxiety and depression levels.
It will be measured by the Hospital Anxiety and Depression scale (HAD) questionnaire. The HAD scale is a screening instrument for anxiety and depressive disorders. It comprises 14 items rated from 0 to 3. Seven questions relate to anxiety (total A) and seven to depression (total D), giving two scores (maximum score for each = 21).
A score of 0 to 7 means: no symptoms A score between 8 and 10 means: doubtful symptomatology A score of 11 to 21 means: definite symptomatology The higher the score, the more stress and depression are present.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of intuitive eating.
It will be measured by the IES-2-French version questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of compulsive eating.
It will be measured by the BES-French version questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of mindfulness.
It will be measured by the FFMQ-French version questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in eating behavior.
It will be measured by the DEBQ-French version questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in physical activity levels.
It will be measured by the Ricci-Gagnon metric questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in stress levels.
It will be measured by the PSS-French version questionnaire.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Gross weight loss (kg)
It will be measured by a doctor from the Nutrition-Diabetes Department of the Montpellier University Hospital.
Measured: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Dec 2023
- Study start16 Feb 2024
- Primary completion10 Jan 2025
- Study completion10 Jan 2025
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 Overweight and ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, MontpellierThe sponsor's other registered studies.
- 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
- Masking
- None (open label)
- Enrolment
- 56 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Montpellier
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Antoine Avignon, PU-PH, Principal investigator, University Hospital, Montpellier
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06157411
- Sponsor's protocol ID
- RECHMPL22_0210
- Acronym
- MIND-EAT
- Status last verified
- Dec 2025
- First submitted
- 17 Nov 2023
- Last updated
- 22 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Van Beekum M, Shankland R, Rodhain A, Robert M, Marchand C, Herry A, Prioux C, Touvier M, Barday M, Turgon R, Avignon A, Leys C, Peneau S. Development and validation of the mindful eating scale (mind-eat scale) in a general population. Appetite. 2024 Aug 1;199:107398. doi: 10.1016/j.appet.2024.107398. Epub 2024 May 6.
PubMed 38710449Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Shankland R, Rodhain A, Bellicha A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a healthier plant-based diet in the NutriNet-Sante study. Sci Rep. 2025 Jun 6;15(1):19928. doi: 10.1038/s41598-025-02195-5.
PubMed 40481021Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Srour B, Bellicha A, Shankland R, Rodhain A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a better diet quality in the NutriNet-Sante study. Appetite. 2025 Feb 1;206:107797. doi: 10.1016/j.appet.2024.107797. Epub 2024 Dec 3.
PubMed 39638150Van Beekum M, Rodhain A, Shankland R, Chetouane S, Jullien-Durmont D, Rouzic CL, Myzia J, Guiraudou M, Kemba Y, Boegner C, Bonnet JB, Attalin V, Jalek A, Sultan A, Leys C, Peneau S, Avignon A. The mind-eat program leads to greater improvements in mindful, emotional, and external eating compared to intuitive eating-oriented education in adults with overweight or obesity: a randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 21;23(1):72. doi: 10.1186/s12966-026-01931-y.
PubMed 42163359
Study at a glance
From the registry record, last updated by the sponsor on 22 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validation of a Mindful Eating Program Adapted to the French Population Living With Overweight or Obesity
- ClinicalTrials.gov ID
- NCT06157411
- Acronym / sponsor ID
- MIND-EAT / RECHMPL22_0210
- Conditions
- Overweight and Obesity
- Keywords
- Mindful eating, Mindfulness, Validation program, Mixed methods
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 56 participants (actual)
- Lead sponsor
- University Hospital, MontpellierUniversity, hospital or other
- Study start
- 16 Feb 2024 (actual)
- Primary completion
- 10 Jan 2025 (actual)
- Study completion
- 10 Jan 2025 (actual)
- First posted
- 5 Dec 2023 (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 project is to validate a new mindful eating programme adapted to the overweight or obese French population. Recognising the importance of diet in the management of chronic diseases, particularly obesity, and the limitations of traditional weight management approaches, the study focuses on the application of mindful eating. The investigators have adapted a model based on an existing eating disorders programme overseas, taking into account feedback from participants in a qualitative study and the scientific literature. The ultimate aim is to test and validate the effectiveness of this new programme in improving the care of overweight or obese French adults, thereby filling a gap in interventions for this population in France.
Detailed description
This research will take the form of a single-center, randomized, two-arm trial comparing a mindful eating intervention (AC group) with a conventional dietary intervention (DC group). The investigators plan to enroll 56 patients who will be randomized to these two groups with stratification based on gender, age (<45, >=45), and BMI (25-30, >30). Randomization will be performed by minimization.
Participants in the AC group (N=28) will follow a program led by an instructor trained in nutrition and mindfulness, incorporating the Alberts program adapted for the overweight or obese population. For 8 consecutive weeks, comprising one 2-hour group session per week at Montpellier University Hospital and individual exercises at home.
Participants in the DC group (N=28) will follow the standard weight management program normally offered by the Nutrition - Diabetes Unit of the Montpellier University Hospital.
This research also includes a qualitative study for the AC group, based on focus groups set up after the end of the mindful eating program.
Participants will be recruited from all consecutive overweight or obese patients attending the Nutrition and Diabetes Unit of the University Hospital of Montpellier who have not yet been enrolled in the therapeutic education program. The unit sees over 1,000 patients a year who meet the criteria for this study.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Mindful Eating Intervention (AC group) | Experimental | Behavioral: Mindful Eating Intervention (AC group)* Mindful eating program: Two sub-groups of 14 participants will follow the program for 8 consecutive weeks. * Follow-up group session: The two groups of 14 participants will each attend a follow-up group session. * 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program. * Focus groups: The two groups of 14 participants will be divided into two (N=7, x4) for a focus group session. |
| Conventional Dietetic Intervention (DC group) | Active comparator | Behavioral: Conventional Dietetic Intervention (DC group)* Therapeutic education program (ETP): The 28 participants will follow the ETP program "Obesity: living better, balancing my weight". * Follow-up group session: The 28 participants will have an individual follow-up session in the form of a final Shared Educational Assessment. * 3 visits with a doctor: The 28 participants will have a pre-intervention visit, a post-intervention visit, and a final visit 3 months after the program. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- First visit to the Nutrition and Diabetes Unit of Montpellier University Hospital for overweight/obesity
- Adults aged 18 and over, volunteers
- BMI ≥ 25kg/m² and ≤ 50kg/m²
- Provisional verbal consent followed by signed written consent
Key exclusion criteria (9 listed)
- People who are illiterate or suffer from a major cognitive impairment that prevents them from understanding the study and the mindful eating program
- Pregnant or breast-feeding women
- People who are taking medicines that may have an effect on their weight (especially GLP-1 analogs, neuroleptics, corticosteroids)
- Anyone with a history of bariatric surgery or scheduled bariatric surgery within the next 6 months
- Presence of co-morbidities or severe pathologies (in particular respiratory failure, heart failure, cancer)
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 |
|---|---|---|
| Mindful Eating Intervention (AC group)Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist. Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups. Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform. Mindful eating program: group sessions one evening a week (8x2h) and home exercises (30 min/day). Visit 2: visit identical to visit 1 Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations. Visit 3: visit identical to visit 1 Focus groups: Each participant will be asked to describe the program and talk about their perceptions and feelings, as well as the potential changes in behavior they have observed in their daily life. | Behavioural | Mindful Eating Intervention (AC group) |
| Conventional Dietetic Intervention (DC group)Screening visit: Patients will meet with a doctor, a dietician, a teacher of adapted physical activity or a psychologist. Visit 0: Following 24 to 72 hours of reflection, the investigator will confirm the patient's understanding of the study, and those expressing verbal willingness will be randomized into the two groups. Visit 1: Participants will be weighed and required to fill out eight questionnaires on a secure platform. Visit 2: visit identical to visit 1 Follow-up group session: To assess each person's progress according to their needs, resources, difficulties, life plans, and initial expectations. Visit 3: visit identical to visit 1 | Behavioural | Conventional Dietetic Intervention (DC group) |
Primary outcome
Variation in the level of mindful eating.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
It will be measured by the Mind-Eat Scale questionnaire. The Mind-Eat Scale is the first questionnaire to provide a total score of the level of mindful eating and is available in French. This questionnaire was developed and validated as part of the Mind-eat project led by our research team, and the corresponding scientific publication is currently being published.
8 secondary outcomes
Variation in anxiety and depression levels.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of intuitive eating.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of compulsive eating.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in the level of mindfulness.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in eating behavior.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in physical activity levels.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Variation in stress levels.
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
Gross weight loss (kg)
Time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).
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 22 Dec 2025.
- Results publication: PubMed 38710449Van Beekum M, Shankland R, Rodhain A, Robert M, Marchand C, Herry A, Prioux C, Touvier M, Barday M, Turgon R, Avignon A, Leys C, Peneau S. Development and validation of the mindful eating scale (mind-eat scale) in a general population. Appetite. 2024 Aug 1;199:107398. doi: 10.1016/j.appet.2024.107398. Epub 2024 May 6.
- Results publication: PubMed 40481021Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Shankland R, Rodhain A, Bellicha A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a healthier plant-based diet in the NutriNet-Sante study. Sci Rep. 2025 Jun 6;15(1):19928. doi: 10.1038/s41598-025-02195-5.
- Results publication: PubMed 39638150Paolassini-Guesnier P, Van Beekum M, Kesse-Guyot E, Baudry J, Srour B, Bellicha A, Shankland R, Rodhain A, Leys C, Hercberg S, Touvier M, Alles B, Peneau S. Mindful eating is associated with a better diet quality in the NutriNet-Sante study. Appetite. 2025 Feb 1;206:107797. doi: 10.1016/j.appet.2024.107797. Epub 2024 Dec 3.
- Derived from this study: PubMed 42163359Van Beekum M, Rodhain A, Shankland R, Chetouane S, Jullien-Durmont D, Rouzic CL, Myzia J, Guiraudou M, Kemba Y, Boegner C, Bonnet JB, Attalin V, Jalek A, Sultan A, Leys C, Peneau S, Avignon A. The mind-eat program leads to greater improvements in mindful, emotional, and external eating compared to intuitive eating-oriented education in adults with overweight or obesity: a randomized controlled trial. Int J Behav Nutr Phys Act. 2026 May 21;23(1):72. doi: 10.1186/s12966-026-01931-y.
- 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.
Antoine Avignon, PU-PH principal investigator
University Hospital, Montpellier
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Mindful Eating Intervention (AC group) and Conventional Dietetic Intervention (DC group) in people with Overweight and Obesity, run by University Hospital, Montpellier at 1 site in France.
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 4 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 22 Dec 2025. 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 France. 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?
Variation in the level of mindful eating. (time frame: Assess at visit 1 (10 days before program start), visit 2 (7 days after program end) and visit 3 (3 months after program end).). 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 NCT06157411, 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 22 Dec 2025.