DiabetesNCT05468411
Effects of Miracle Fruit Pill Application on Food Likings and Energy Intake in Diabetic or Prediabetic Patients
A study testing Oral application of miracle fruit pill and Oral application of sugar candy in people with Diabetes and PreDiabetes, run by Queens College, The City University of New York at 1 site in United States.
Trial summary
The high prevalence of diabetes and prediabetes has increased the demand for nonnutritive sweeteners in recent years. Miracle fruit has been considered a healthy alternative sweetener for diabetic patients due to its sweetness-enhancing effects and high antioxidant activity. Read more about this study
- Who is it for?
- Ages 45 to 75 years
- Conditions the study is for
- Diabetes, PreDiabetes
- What is being tested?
- Oral application of miracle fruit pill and Oral application of sugar candy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2019to 31 Dec 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Having a score of 5 or higher on the 'Prediabetes Risk Test' provided by the American Diabetes Association and the Centers for Disease Control and Prevention
- Having been diagnosed with prediabetes or diabetes by doctor
Who cannot join
- Smoking
- Having food allergies or food intolerances
- Being diagnosed with taste disorders
- Being pregnant
- Breastfeeding
- Using medications that could affect taste perception and food intake
Trial locations and contacts
1 site in 1 country.
United States1 site
Korean Community Services of Metropolitan New York, Inc.
Bayside, New York, 11361
About this study
Official title: Effects of Oral Application of Miracle Fruit Pill Before Eating Food on Food Likings and Energy Intake in Diabetic or Prediabetic Patients: A Randomized Crossover Trial
The high prevalence of diabetes and prediabetes has increased the demand for nonnutritive sweeteners in recent years. Miracle fruit has been considered a healthy alternative sweetener for diabetic patients due to its sweetness-enhancing effects and high antioxidant activity. The purposes of this study are to examine whether the miracle fruit pill application to mouth prior to food consumption could improve the likings of different types of sour food (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and reduce energy intakes at the meals. Fifty volunteers (25 men and 25 women) aged 45 to 75 years with diabetes or prediabetes participate in the study. In this study, two interventions (miracle fruit and placebo) are provided, and all participants receive both applications. Participants are randomly assigned to one of the two interventions in part 1 and the assignment is switched from one application to another in part 2. The study hypotheses of this study are that the miracle fruit intervention improves the likings for sour foods and meals more than the placebo does; The miracle fruit intervention also reduces energy intakes from the meals more than the placebo does. Participants are asked to participate in a total of 6 sessions (1 hour/session, 1 session/day, Part 1: session 1, 2, \& 3, Part 2: session 4, 5, \& 6). Each session consists of two 30-min assessments, which are liking tests and meal intake assessment. The potential participants who have known food allergies or food intolerances are screened through consented screening procedure. If unknown food allergies or intolerances unintentionally become present during the study, medical help will be sought immediately. Participants may enjoy food samples and meals provided in this study and benefit by learning more about their acceptances for miracle fruit pill as an alternative sweetener. The results of this research are expected to develop generalizable knowledge about the miracle fruit's potential to improve the food palatability for people with diabetes or prediabetes.
Read the detailed description
Due to the rise in rates of obesity and diabetes in recent years, the consumer demand for alternative sweetener is growing especially among people with diabetes or prediabetes. Given the need for alternative sweeteners, miracle fruit (Synsepalum dulcificum) may be a good candidate to fulfill the demand. Miracle fruit has been used as a sweet enhancer for thousands of years by the natives in Western Africa without any reports of adverse effects. The red, cranberry-sized miracle fruit is named for its unique ability to transform sour taste into sweet. In addition to the miracle fruit's taste modification function, miracle fruit has valuable antioxidant activities that can be applied for functional food and has also been studied to improve insulin resistance induced by fructose-rich chow in rats. With the potential health benefit of miracle fruit, miracle fruit has been considered as a healthy alternative sweetener that can meet diabetic patients' needs. However, for the practical applications of miracle fruit for diabetic diet, the acceptability of miracle fruit and its effect on energy intake need to be examined among diabetic patients. Fresh miracle fruits are highly perishable, and they cannot be cooked because the taste modifying effect found in the pulp of the miracle fruit is due to a protein, which is deactivated by heat. For these reasons, a freeze-dried pill form of miracle fruit needs to be applied on a tongue to coat taste buds before food is consumed. Therefore, in this study, the effects of oral application of miracle fruit pill are compared with placebo (sugar candy) on the likings of different sour food products (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and energy intakes from the meals in people with diabetes or prediabetes. A total of 50 patients aged 45 to 75 years who have been diagnosed with diabetes or prediabetes (25 men and 25 women) participate in this study. They should be nonsmokers; not have food allergies or food intolerances; not be diagnosed with taste disorders; not be pregnant; not breastfeed; and not use medications that could affect taste perception and food intake. This study is a randomized placebo-controlled crossover trial. As an intervention, a miracle fruit pill is orally administered prior to eating food samples. The same protocol is followed in the control group but with placebo (sugar candy). Participants are asked to participate in a total of six 1-hour sessions (1 session/day). Participants are randomly assigned to either of two applications (miracle fruit and placebo) in part 1 and one week after part 1 (1-week washout), their intervention assignment is switched from one application to another in part 2. Each part/intervention consists of 3 sessions and each session consists of two assessments (liking tests and meal intake assessment). In each part/intervention, each participant performs the liking tests for five sour foods in triplicate and consumes breakfast, lunch, and dinner meals once. The order of the experiments in each session is as follows: 1. preliking test; 2. miracle fruit pill/placebo administration; 3. postliking test; and 4. meal intake. At the liking tests, the pre- and postlikings of overall, flavor, texture, and aftertaste for all 5 sour food samples are assessed using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For the meal intake assessment, standardized breakfast, lunch, and dinner meals are provided to participants according to the experimental design. During the meal intake session, participants are allowed to consume any food, beverage, or condiments, including sweeteners that are provided at the session. All foods and beverages that are consumed by each participant at the meals are weighed, and the energy intakes from the meals are calculated using the food weight via online nutrient tracker.
- Conditions
- Diabetes, PreDiabetes
- Being tested
- Oral application of miracle fruit pill, Oral application of sugar candy
- Keywords
- Miracle fruit, Alternative sweetener, Taste liking, Energy intake, Placebo
- Medical subject headings
- Diabetes Mellitus, Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral application of miracle fruit pillOther
Miracle fruit has a taste modifying function from sourness to sweetness when it is exposed to an acidic environment. To activate the miracle fruit's function, a miracle fruit pill should be orally administered to coat taste buds prior to eating sour food. Thus, participants are instructed to place a miracle fruit pill is on their tongue, and roll the pill around their mouth to allow full contact of the pill with the surface of the oral cavity without chewing until the pill completely dissolved. A miracle fruit pill is administered prior to eating.
Oral application of sugar candyOther
To simulate the miracle fruit's function as a placebo, a chewable sugar candy that has a similar appearance to miracle fruit pill is orally administered. The same protocol that is used in miracle fruit intervention is followed in this placebo intervention but with a chewable sugar candy. Participants are instructed to place a sugar candy is on their tongue, and roll the candy around their mouth to allow full contact of the candy with the surface of the oral cavity without chewing until the candy completely dissolved. A sugar candy is administered prior to eating.
| Study group | Role | What they receive |
|---|---|---|
| Miracle fruit pill | Active comparator | A freeze-dried miracle fruit pill is orally administered prior to eating food samples. Receives: Other: Oral application of miracle fruit pill; Other: Oral application of sugar candy |
| Sugar candy | Placebo comparator | A chewable sugar candy is orally administered as a placebo prior to eating food samples. Receives: Other: Oral application of miracle fruit pill; Other: Oral application of sugar candy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Changes in food liking from pre- to post-intervention
Changes in food liking for sour food samples (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) are measured by comparing pre-and post-liking scores for sour food samples. Before the intervention (oral application of miracle fruit pill or placebo sugar candy) is applied, the pre-liking is assessed by tasting each food sample. After the pre-liking test is done, the intervention is applied. It takes approximately 5 minutes for intervention pills (miracle fruit pill or sugar candy) to dissolve. After the oral application/intervention is completed, the post-liking is assessed in the same way as the pre-liking. The pre- and post-likings for overall, flavor, texture, and aftertaste are evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For "aftertaste pleasantness", the 'no aftertaste detected' answer option is additionally provided.
Measured: The pre-liking test (10 minutes),intervention application & break (10 minutes), and post-liking test (10 minutes) are conducted consecutively and completed within a session.
Energy intake from meals
All foods and beverages that are served to each participant at the meal sessions are preweighed, and food intake is assessed by measuring their remaining food and beverages. The energy intake of each participant is calculated using the food weight on an online nutrient analysis site.
Measured: Each participant's food intake is measured for 30 minutes.
Overall liking for meals
Overall liking for each of meals (breakfast, lunch, and dinner) is evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely).
Measured: Immediately after the energy intake measurement is done, overall liking for each meal is evaluated.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Jul 2022
- Study start1 Nov 2019
- Primary completion28 Feb 2020
- Study completion31 Dec 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- This study is a randomized crossover trial that has two interventions (miracle fruit pill and placebo). This means that participants have a 100% chance of getting both applications. Participants are asked to participate in a total of six sessions (Part 1: session 1, 2, \& 3, Part 2: session 4, 5, \& 6). Participants are randomly assigned to either of two interventions (miracle fruit and placebo) in part 1 and their assignment are switched from one application to another in part 2.
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Queens College, The City University of New York
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Sungeun Choi, PhD, Principal investigator, Queens College, CUNY
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05468411
- Sponsor's protocol ID
- PSC-CUNY 62192-00-50
- Status last verified
- Sep 2022
- First submitted
- 6 Jul 2022
- Last updated
- 15 Sep 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All collected IPD in a publication.
Publications
Choi S, Park T. Feasibility and acceptability of miracle fruit application prior to the consumption of sour-tasting foods as a weight-loss strategy in adults with diabetes or prediabetes: A randomized crossover trial. Appetite. 2023 Dec 1;191:107046. doi: 10.1016/j.appet.2023.107046. Epub 2023 Sep 17.
PubMed 37726068
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Oral Application of Miracle Fruit Pill Before Eating Food on Food Likings and Energy Intake in Diabetic or Prediabetic Patients: A Randomized Crossover Trial
- ClinicalTrials.gov ID
- NCT05468411
- Acronym / sponsor ID
- PSC-CUNY 62192-00-50
- Conditions
- Diabetes, PreDiabetes
- Keywords
- Miracle fruit, Alternative sweetener, Taste liking, Energy intake, Placebo
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Queens College, The City University of New YorkUniversity, hospital or other
- Study start
- 1 Nov 2019 (actual)
- Primary completion
- 28 Feb 2020 (actual)
- Study completion
- 31 Dec 2020 (actual)
- First posted
- 21 Jul 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.
The high prevalence of diabetes and prediabetes has increased the demand for nonnutritive sweeteners in recent years. Miracle fruit has been considered a healthy alternative sweetener for diabetic patients due to its sweetness-enhancing effects and high antioxidant activity. The purposes of this study are to examine whether the miracle fruit pill application to mouth prior to food consumption could improve the likings of different types of sour food (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and reduce energy intakes at the meals. Fifty volunteers (25 men and 25 women) aged 45 to 75 years with diabetes or prediabetes participate in the study. In this study, two interventions (miracle fruit and placebo) are provided, and all participants receive both applications. Participants are randomly assigned to one of the two interventions in part 1 and the assignment is switched from one application to another in part 2. The study hypotheses of this study are that the miracle fruit intervention improves the likings for sour foods and meals more than the placebo does; The miracle fruit intervention also reduces energy intakes from the meals more than the placebo does. Participants are asked to participate in a total of 6 sessions (1 hour/session, 1 session/day, Part 1: session 1, 2, \& 3, Part 2: session 4, 5, \& 6). Each session consists of two 30-min assessments, which are liking tests and meal intake assessment. The potential participants who have known food allergies or food intolerances are screened through consented screening procedure. If unknown food allergies or intolerances unintentionally become present during the study, medical help will be sought immediately. Participants may enjoy food samples and meals provided in this study and benefit by learning more about their acceptances for miracle fruit pill as an alternative sweetener. The results of this research are expected to develop generalizable knowledge about the miracle fruit's potential to improve the food palatability for people with diabetes or prediabetes.
Detailed description
Due to the rise in rates of obesity and diabetes in recent years, the consumer demand for alternative sweetener is growing especially among people with diabetes or prediabetes. Given the need for alternative sweeteners, miracle fruit (Synsepalum dulcificum) may be a good candidate to fulfill the demand. Miracle fruit has been used as a sweet enhancer for thousands of years by the natives in Western Africa without any reports of adverse effects. The red, cranberry-sized miracle fruit is named for its unique ability to transform sour taste into sweet. In addition to the miracle fruit's taste modification function, miracle fruit has valuable antioxidant activities that can be applied for functional food and has also been studied to improve insulin resistance induced by fructose-rich chow in rats. With the potential health benefit of miracle fruit, miracle fruit has been considered as a healthy alternative sweetener that can meet diabetic patients' needs. However, for the practical applications of miracle fruit for diabetic diet, the acceptability of miracle fruit and its effect on energy intake need to be examined among diabetic patients. Fresh miracle fruits are highly perishable, and they cannot be cooked because the taste modifying effect found in the pulp of the miracle fruit is due to a protein, which is deactivated by heat. For these reasons, a freeze-dried pill form of miracle fruit needs to be applied on a tongue to coat taste buds before food is consumed. Therefore, in this study, the effects of oral application of miracle fruit pill are compared with placebo (sugar candy) on the likings of different sour food products (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) and meals (breakfast, lunch, and dinner), and energy intakes from the meals in people with diabetes or prediabetes. A total of 50 patients aged 45 to 75 years who have been diagnosed with diabetes or prediabetes (25 men and 25 women) participate in this study. They should be nonsmokers; not have food allergies or food intolerances; not be diagnosed with taste disorders; not be pregnant; not breastfeed; and not use medications that could affect taste perception and food intake. This study is a randomized placebo-controlled crossover trial. As an intervention, a miracle fruit pill is orally administered prior to eating food samples. The same protocol is followed in the control group but with placebo (sugar candy). Participants are asked to participate in a total of six 1-hour sessions (1 session/day). Participants are randomly assigned to either of two applications (miracle fruit and placebo) in part 1 and one week after part 1 (1-week washout), their intervention assignment is switched from one application to another in part 2. Each part/intervention consists of 3 sessions and each session consists of two assessments (liking tests and meal intake assessment). In each part/intervention, each participant performs the liking tests for five sour foods in triplicate and consumes breakfast, lunch, and dinner meals once. The order of the experiments in each session is as follows: 1. preliking test; 2. miracle fruit pill/placebo administration; 3. postliking test; and 4. meal intake. At the liking tests, the pre- and postlikings of overall, flavor, texture, and aftertaste for all 5 sour food samples are assessed using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For the meal intake assessment, standardized breakfast, lunch, and dinner meals are provided to participants according to the experimental design. During the meal intake session, participants are allowed to consume any food, beverage, or condiments, including sweeteners that are provided at the session. All foods and beverages that are consumed by each participant at the meals are weighed, and the energy intakes from the meals are calculated using the food weight via online nutrient tracker.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- This study is a randomized crossover trial that has two interventions (miracle fruit pill and placebo). This means that participants have a 100% chance of getting both applications. Participants are asked to participate in a total of six sessions (Part 1: session 1, 2, \& 3, Part 2: session 4, 5, \& 6). Participants are randomly assigned to either of two interventions (miracle fruit and placebo) in part 1 and their assignment are switched from one application to another in part 2.
| Arm | Type | Receives |
|---|---|---|
| Miracle fruit pill | Active comparator | Other: Oral application of miracle fruit pill, Other: Oral application of sugar candyA freeze-dried miracle fruit pill is orally administered prior to eating food samples. |
| Sugar candy | Placebo comparator | Other: Oral application of miracle fruit pill, Other: Oral application of sugar candyA chewable sugar candy is orally administered as a placebo prior to eating food samples. |
Who may qualify
- Ages
- 45 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Having a score of 5 or higher on the 'Prediabetes Risk Test' provided by the American Diabetes Association and the Centers for Disease Control and Prevention
- Having been diagnosed with prediabetes or diabetes by doctor
Key exclusion criteria (6 listed)
- Smoking
- Having food allergies or food intolerances
- Being diagnosed with taste disorders
- Being pregnant
- Breastfeeding
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 |
|---|---|---|
| Oral application of miracle fruit pillMiracle fruit has a taste modifying function from sourness to sweetness when it is exposed to an acidic environment. To activate the miracle fruit's function, a miracle fruit pill should be orally administered to coat taste buds prior to eating sour food. Thus, participants are instructed to place a miracle fruit pill is on their tongue, and roll the pill around their mouth to allow full contact of the pill with the surface of the oral cavity without chewing until the pill completely dissolved. A miracle fruit pill is administered prior to eating. | Other | Miracle fruit pill, Sugar candy |
| Oral application of sugar candyTo simulate the miracle fruit's function as a placebo, a chewable sugar candy that has a similar appearance to miracle fruit pill is orally administered. The same protocol that is used in miracle fruit intervention is followed in this placebo intervention but with a chewable sugar candy. Participants are instructed to place a sugar candy is on their tongue, and roll the candy around their mouth to allow full contact of the candy with the surface of the oral cavity without chewing until the candy completely dissolved. A sugar candy is administered prior to eating. | Other | Miracle fruit pill, Sugar candy |
Primary outcome
Changes in food liking from pre- to post-intervention
Time frame: The pre-liking test (10 minutes),intervention application & break (10 minutes), and post-liking test (10 minutes) are conducted consecutively and completed within a session.
Changes in food liking for sour food samples (green apple, goat cheese, lemonade, cucumber pickle, and plain fat-free yogurt) are measured by comparing pre-and post-liking scores for sour food samples. Before the intervention (oral application of miracle fruit pill or placebo sugar candy) is applied, the pre-liking is assessed by tasting each food sample. After the pre-liking test is done, the intervention is applied. It takes approximately 5 minutes for intervention pills (miracle fruit pill or sugar candy) to dissolve. After the oral application/intervention is completed, the post-liking is assessed in the same way as the pre-liking. The pre- and post-likings for overall, flavor, texture, and aftertaste are evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely). For "aftertaste pleasantness", the 'no aftertaste detected' answer option is additionally provided.
Energy intake from meals
Time frame: Each participant's food intake is measured for 30 minutes.
All foods and beverages that are served to each participant at the meal sessions are preweighed, and food intake is assessed by measuring their remaining food and beverages. The energy intake of each participant is calculated using the food weight on an online nutrient analysis site.
Overall liking for meals
Time frame: Immediately after the energy intake measurement is done, overall liking for each meal is evaluated.
Overall liking for each of meals (breakfast, lunch, and dinner) is evaluated using a 9-point hedonic scale (1=dislike extremely, 9=like extremely).
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 15 Sep 2022.
- Derived from this study: PubMed 37726068Choi S, Park T. Feasibility and acceptability of miracle fruit application prior to the consumption of sour-tasting foods as a weight-loss strategy in adults with diabetes or prediabetes: A randomized crossover trial. Appetite. 2023 Dec 1;191:107046. doi: 10.1016/j.appet.2023.107046. Epub 2023 Sep 17.
- Individual participant dataSharing planned: Yes. All collected IPD in a publication.
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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.
Sungeun Choi, PhD principal investigator
Queens College, CUNY
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Oral application of miracle fruit pill and Oral application of sugar candy in people with Diabetes and PreDiabetes, run by Queens College, The City University of New York at 1 site in United States.
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 6 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 15 Sep 2022. 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 United States. 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. Some participants in this study may receive a placebo. 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?
Changes in food liking from pre- to post-intervention (time frame: The pre-liking test (10 minutes),intervention application & break (10 minutes), and post-liking test (10 minutes) are conducted consecutively and completed within a session.). 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 NCT05468411, which also lists 1 linked publication.
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 15 Sep 2022.