Dietary BehavioursNCT06631469
Behaviour-focused Personalised Nutrition Intervention
A study testing Personalised behavioural sustainable and healthy dietary recommendations and Personalised sustainable and healthy dietary recommendations in people with Dietary Behaviours and Sustainable Healthy Diet, run by University College Dublin at 1 site in Ireland.
Trial summary
The aim of this study is to test the efficacy, feasibility, and acceptability of a novel, behaviour-focused personalised nutrition intervention compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in university students. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dietary Behaviours, Sustainable Healthy Diet, Personalised Nutrition
- What is being tested?
- Personalised behavioural sustainable and healthy dietary recommendations and Personalised sustainable and healthy dietary recommendations
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 57 participants
- Where
- 1 siteIreland
- Study dates
- 1 Oct 2024to 26 Feb 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 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Be a UCD student (aged 18-30 years) attending Belfield Campus.
- Be an adult between the age of 18-30 years old, and in general good health.
Who cannot join
- Do not attend UCD Belfield Campus.
- Are under 18 years of age or over 30 years of age.
- Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnosis include (but not limited to) cardiovascular disease, diabetes mellitus, cancers (within the past 5 years), etc.
- Are pregnant, lactating or planning to become pregnant.
- Are following a medically prescribed diet.
- Are immunocompromised or have a suspected immunodeficiency.
Show all 9Show fewer
- Have a known food allergy.
- Taking part in another diet-related research study that could interfere with the outcomes of this study
- Consume ≥2 servings per day of legumes.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Behaviour-focused Personalised Nutrition Intervention to Promote Sustainable and Healthy Diets in University Students: a Feasibility Pilot Study
The aim of this study is to test the efficacy, feasibility, and acceptability of a novel, behaviour-focused personalised nutrition intervention compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in university students.
Read the detailed description
Participants will be recruited from the University College Dublin (UCD) PLAN'EAT Living Lab (LL) Citizen Panel which will form a separate registration. The UCD PLAN'EAT LL is a series of studies designed to develop, implement, and evaluate strategies to support University students' transition towards a sustainable healthy diet. The UCD PLAN'EAT LL study will recruit up to n=500 healthy students (aged 18-30 years) attending UCD, Belfield Campus, to join the UCD PLAN'EAT LL Citizen Panel. Upon successful screening and completion of informed consent, participants will be invited to join the UCD PLAN'EAT LL Citizen Panel and complete initial baseline data collection measures (which will be detailed in a separate registration). Following completion of this baseline data collection, participants within the UCD PLAN'EAT LL Citizen Panel will be subsequently invited to participate in this study detailed below.
Participants within the UCD PLAN'EAT LL Citizen Panel will be invited to participate in a 4-week study. This study will aim to recruit n=40 participants within the UCD PLAN'EAT LL Citizen Panel. After successful screening and informed consent, participants will be randomised into two separate groups (n=20 control group; n=20 intervention group) receiving different types of personalised recommendations and strategies using decision tree algorithms to support them to consume a healthier and more sustainable diet. The control group will receive a personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) to meet their personalised dietary recommendations. The intervention group will receive the same as the control group, with the addition of receiving personalised behavioural support and strategies to help them meet their personalised dietary recommendations.
Baseline: Participants will be asked to complete a questionnaire including questions on demographics, health, dietary behaviours, and lifestyle and a dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of baseline measures, participants will be invited to attend a study visit in UCD. Participants will undergo a diet counselling session, where they will receive a personalised feedback report and advice from a nutritionist on how to achieve their goal of eating a more sustainable and healthy diet.
Midpoint: Participants will be contacted by a member of the research team via email or phone message to check their progression and to address any queries.
Endpoint: At the end of the 4-week study, participants will complete a diet-related questionnaire and a second dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of endpoint measures, retention rates (number of participants who complete endpoint measures / number of participants enrolled into the study x 100) and data completion rates (number of complete datasets for each outcome measure / number of participants enrolled ×100) will be calculated to assess study feasibility and acceptability.
Process Evaluation:
At the end of this study, all participants will be invited to complete a study evaluation questionnaire including feasibility, acceptability, and engagement measures. In addition, a subsample of participants will also be invited to participate in focus groups or one-to-one interviews to explore topics on study feasibility encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers/ enablers), study engagement, and suggestions for improvement. The focus groups or one-to-one interviews will be guided by the APEASE (Acceptability, Practicality, Effectiveness, Affordability, Side-effects, Equity) criteria.
- Being tested
- Personalised behavioural sustainable and healthy dietary recommendations, Personalised sustainable and healthy dietary recommendations
- Keywords
- Sustainable diet, Personalised nutrition, Dietary behaviours, University, Students
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Personalised behavioural sustainable and healthy dietary recommendationsBehavioural
Personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus the addition of receiving personalised behavioural support and strategies.
Personalised sustainable and healthy dietary recommendationsBehavioural
Personalised dietary plan and standardised behavioural support and strategies (based on previous personalised nutrition trials and usual care in dietetic practice).
| Study group | Role | What they receive |
|---|---|---|
| Personalised behavioural sustainable and healthy dietary recommendations | Experimental | Personalised dietary plan, standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus personalised behavioural support and strategies aimed at meeting personalised dietary recommendations. Receives: Behavioral: Personalised behavioural sustainable and healthy dietary recommendations |
| Personalised sustainable and healthy dietary recommendations | Active comparator | Personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) aimed at meeting personalised dietary recommendations. Receives: Behavioral: Personalised sustainable and healthy dietary recommendations |
What is being measured
The primary outcome is the main question the study is designed to answer.
Legume intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Legume intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The primary outcome measure is the change in legume intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
Secondary outcomes (5)
Plant-based food intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Plant-based food intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in plant-based food intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
Fruit intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Fruit intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in fruit intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
Vegetable intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Vegetable intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in vegetable intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
Meat intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Meat intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in meat intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
High fat, sugar, salt (HFSS) food intake (grams per day)
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. High fat, sugar, and salt food intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The secondary outcome measure is the change in high fat, sugar, and salt food intake (g/ day) as a result of the intervention diet.
Measured: 4 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Oct 2024
- Study start1 Oct 2024
- Primary completion29 Dec 2024
- Study completion26 Feb 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 Dietary BehavioursStudies 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Parallel randomized controlled trial
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 57 participants (actual)
Sponsor and investigators
- Lead sponsor
- University College Dublin
- Sponsor type
- University, hospital or other
- Collaborators
- PLAN'EAT Consortium (https://planeat-project.eu/)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06631469
- Sponsor's protocol ID
- LS-23-72-Gibney
- Other IDs
- 101061023
- Status last verified
- Oct 2024
- First submitted
- 4 Oct 2024
- Last updated
- 18 Apr 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the beginning of the study, each participant will have a study code assigned to them. All data collected from the study will be stored using these unique study codes. A file will be set up which will be stored in a separate location to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be password-protected and only accessible to the research team/ named researchers on the project. Pseudonymised/ anonymised data will be shared with PLAN'EAT partners where appropriate.
Publications
Davies KP, Gibney ER, Leonard UM, Lindberg L, Woodside JV, Kiely ME, Nugent AP, Arranz E, Conway MC, McCarthy SN, O'Sullivan AM. Developing and testing personalised nutrition feedback for more sustainable healthy diets: the MyPlanetDiet randomised controlled trial protocol. Eur J Nutr. 2024 Oct;63(7):2681-2696. doi: 10.1007/s00394-024-03457-0. Epub 2024 Jul 6.
PubMed 38970665Macready AL, Fallaize R, Butler LT, Ellis JA, Kuznesof S, Frewer LJ, Celis-Morales C, Livingstone KM, Araujo-Soares V, Fischer AR, Stewart-Knox BJ, Mathers JC, Lovegrove JA. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 9;7(4):e87. doi: 10.2196/resprot.8703.
PubMed 29631993Writing Group of the Nutrition Care Process/Standardized Language Committee. Nutrition care process and model part I: the 2008 update. J Am Diet Assoc. 2008 Jul;108(7):1113-7. doi: 10.1016/j.jada.2008.04.027. No abstract available.
PubMed 18589014Rigby RR, Mitchell LJ, Hamilton K, Williams LT. The Use of Behavior Change Theories in Dietetics Practice in Primary Health Care: A Systematic Review of Randomized Controlled Trials. J Acad Nutr Diet. 2020 Jul;120(7):1172-1197. doi: 10.1016/j.jand.2020.03.019. Epub 2020 May 20.
PubMed 32444328
Study at a glance
From the registry record, last updated by the sponsor on 18 Apr 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Behaviour-focused Personalised Nutrition Intervention to Promote Sustainable and Healthy Diets in University Students: a Feasibility Pilot Study
- ClinicalTrials.gov ID
- NCT06631469
- Acronym / sponsor ID
- LS-23-72-Gibney
- Keywords
- Sustainable diet, Personalised nutrition, Dietary behaviours, University, Students
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 57 participants (actual)
- Lead sponsor
- University College DublinUniversity, hospital or other
- Collaborators
- PLAN'EAT Consortium (https://planeat-project.eu/)
- Study start
- 1 Oct 2024 (actual)
- Primary completion
- 29 Dec 2024 (actual)
- Study completion
- 26 Feb 2025 (actual)
- First posted
- 8 Oct 2024 (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 study is to test the efficacy, feasibility, and acceptability of a novel, behaviour-focused personalised nutrition intervention compared to a control personalised nutrition intervention for improving adherence to sustainable and healthy dietary recommendations in university students.
Detailed description
Participants will be recruited from the University College Dublin (UCD) PLAN'EAT Living Lab (LL) Citizen Panel which will form a separate registration. The UCD PLAN'EAT LL is a series of studies designed to develop, implement, and evaluate strategies to support University students' transition towards a sustainable healthy diet. The UCD PLAN'EAT LL study will recruit up to n=500 healthy students (aged 18-30 years) attending UCD, Belfield Campus, to join the UCD PLAN'EAT LL Citizen Panel. Upon successful screening and completion of informed consent, participants will be invited to join the UCD PLAN'EAT LL Citizen Panel and complete initial baseline data collection measures (which will be detailed in a separate registration). Following completion of this baseline data collection, participants within the UCD PLAN'EAT LL Citizen Panel will be subsequently invited to participate in this study detailed below.
Participants within the UCD PLAN'EAT LL Citizen Panel will be invited to participate in a 4-week study. This study will aim to recruit n=40 participants within the UCD PLAN'EAT LL Citizen Panel. After successful screening and informed consent, participants will be randomised into two separate groups (n=20 control group; n=20 intervention group) receiving different types of personalised recommendations and strategies using decision tree algorithms to support them to consume a healthier and more sustainable diet. The control group will receive a personalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) to meet their personalised dietary recommendations. The intervention group will receive the same as the control group, with the addition of receiving personalised behavioural support and strategies to help them meet their personalised dietary recommendations.
Baseline: Participants will be asked to complete a questionnaire including questions on demographics, health, dietary behaviours, and lifestyle and a dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of baseline measures, participants will be invited to attend a study visit in UCD. Participants will undergo a diet counselling session, where they will receive a personalised feedback report and advice from a nutritionist on how to achieve their goal of eating a more sustainable and healthy diet.
Midpoint: Participants will be contacted by a member of the research team via email or phone message to check their progression and to address any queries.
Endpoint: At the end of the 4-week study, participants will complete a diet-related questionnaire and a second dietary assessment. The dietary assessment will include 3 online 24-hour dietary recalls (2 non-consecutive weekdays and 1 weekend day) (via the web-based dietary recall tool, Foodbook24).
Following completion of endpoint measures, retention rates (number of participants who complete endpoint measures / number of participants enrolled into the study x 100) and data completion rates (number of complete datasets for each outcome measure / number of participants enrolled ×100) will be calculated to assess study feasibility and acceptability.
Process Evaluation:
At the end of this study, all participants will be invited to complete a study evaluation questionnaire including feasibility, acceptability, and engagement measures. In addition, a subsample of participants will also be invited to participate in focus groups or one-to-one interviews to explore topics on study feasibility encompassing, for example, their study experience, study acceptability, factors affecting participation rates (e.g., barriers/ enablers), study engagement, and suggestions for improvement. The focus groups or one-to-one interviews will be guided by the APEASE (Acceptability, Practicality, Effectiveness, Affordability, Side-effects, Equity) criteria.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Parallel randomized controlled trial
| Arm | Type | Receives |
|---|---|---|
| Personalised behavioural sustainable and healthy dietary recommendations | Experimental | Behavioral: Personalised behavioural sustainable and healthy dietary recommendationsPersonalised dietary plan, standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus personalised behavioural support and strategies aimed at meeting personalised dietary recommendations. |
| Personalised sustainable and healthy dietary recommendations | Active comparator | Behavioral: Personalised sustainable and healthy dietary recommendationsPersonalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice) aimed at meeting personalised dietary recommendations. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Be a UCD student (aged 18-30 years) attending Belfield Campus.
- Be an adult between the age of 18-30 years old, and in general good health.
Key exclusion criteria (9 listed)
- Do not attend UCD Belfield Campus.
- Are under 18 years of age or over 30 years of age.
- Have a diagnosis of an acute or chronic medical condition that could interfere with the outcomes of the study. Such diagnosis include (but not limited to) cardiovascular disease, diabetes mellitus, cancers (within the past 5 years), etc.
- Are pregnant, lactating or planning to become pregnant.
- Are following a medically prescribed diet.
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 |
|---|---|---|
| Personalised behavioural sustainable and healthy dietary recommendationsPersonalised dietary plan and standardised behavioural support (based on previous personalised nutrition trials and usual care in dietetic practice), plus the addition of receiving personalised behavioural support and strategies. | Behavioural | Personalised behavioural sustainable and healthy dietary recommendations |
| Personalised sustainable and healthy dietary recommendationsPersonalised dietary plan and standardised behavioural support and strategies (based on previous personalised nutrition trials and usual care in dietetic practice). | Behavioural | Personalised sustainable and healthy dietary recommendations |
Primary outcome
Legume intake (grams per day)
Time frame: 4 weeks
Participants will record their diet at baseline (habitual diet) and endpoint (intervention diet) using an online 24-hour recall method. Legume intake will be calculated using dietary intake records (baseline: 3x 24-hour recalls; endpoint: 3x 24-hour recalls). The primary outcome measure is the change in legume intake (g/ day) as a result of the intervention diet.
5 secondary outcomes
Plant-based food intake (grams per day)
Time frame: 4 weeks
Fruit intake (grams per day)
Time frame: 4 weeks
Vegetable intake (grams per day)
Time frame: 4 weeks
Meat intake (grams per day)
Time frame: 4 weeks
High fat, sugar, salt (HFSS) food intake (grams per day)
Time frame: 4 weeks
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 18 Apr 2025.
- Background: PubMed 38970665Davies KP, Gibney ER, Leonard UM, Lindberg L, Woodside JV, Kiely ME, Nugent AP, Arranz E, Conway MC, McCarthy SN, O'Sullivan AM. Developing and testing personalised nutrition feedback for more sustainable healthy diets: the MyPlanetDiet randomised controlled trial protocol. Eur J Nutr. 2024 Oct;63(7):2681-2696. doi: 10.1007/s00394-024-03457-0. Epub 2024 Jul 6.
- Background: PubMed 29631993Macready AL, Fallaize R, Butler LT, Ellis JA, Kuznesof S, Frewer LJ, Celis-Morales C, Livingstone KM, Araujo-Soares V, Fischer AR, Stewart-Knox BJ, Mathers JC, Lovegrove JA. Application of Behavior Change Techniques in a Personalized Nutrition Electronic Health Intervention Study: Protocol for the Web-Based Food4Me Randomized Controlled Trial. JMIR Res Protoc. 2018 Apr 9;7(4):e87. doi: 10.2196/resprot.8703.
- Background: PubMed 18589014Writing Group of the Nutrition Care Process/Standardized Language Committee. Nutrition care process and model part I: the 2008 update. J Am Diet Assoc. 2008 Jul;108(7):1113-7. doi: 10.1016/j.jada.2008.04.027. No abstract available.
- Background: PubMed 32444328Rigby RR, Mitchell LJ, Hamilton K, Williams LT. The Use of Behavior Change Theories in Dietetics Practice in Primary Health Care: A Systematic Review of Randomized Controlled Trials. J Acad Nutr Diet. 2020 Jul;120(7):1172-1197. doi: 10.1016/j.jand.2020.03.019. Epub 2020 May 20.
- British Dietetic Association. Model and Process for Nutrition and Dietetic Practice. British Dietetic Association; 2021.Link provided by the sponsor.
- Michie S, Atkins L, West R. The Behaviour Change Wheel: A Guide to Designing Interventions. Great Britain: Silverback Publishing; 2014.Link provided by the sponsor.
- Individual participant dataSharing planned: No. At the beginning of the study, each participant will have a study code assigned to them. All data collected from the study will be stored using these unique study codes. A file will be set up which will be stored in a separate location to the study data. This file will contain a list which will link each participants contact details to the corresponding ID code. All stored information will be password-protected and only accessible to the research team/ named researchers on the project. Pseudonymised/ anonymised data will be shared with PLAN'EAT partners where appropriate.
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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 Personalised behavioural sustainable and healthy dietary recommendations and Personalised sustainable and healthy dietary recommendations in people with Dietary Behaviours and Sustainable Healthy Diet, run by University College Dublin at 1 site in Ireland.
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 2 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 18 Apr 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 Ireland. 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?
Legume intake (grams per day) (time frame: 4 weeks). 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 NCT06631469, 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 18 Apr 2025; AzTrials last refreshed its copy on 28 Oct 2026.