Obesity, ChildhoodNCT06464497
Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
A study testing Whole Foods MyPlate Group in people with Obesity, Childhood and Diet, Healthy, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will address the following aims: Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity. Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention. Read more about this study
- Who is it for?
- Ages 10 years and older
- Conditions the study is for
- Obesity, Childhood, Diet, Healthy, Body Weight Changes
- What is being tested?
- Whole Foods MyPlate Group
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 24 Mar 2025to 30 Apr 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 10 years and older
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- For this study, eligible adolescents will be those that:
- 10-18 years of age at time of initial screening;
- living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);
- obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;
- reside within greater Middle Tennessee area and has enrolled parent/caregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;
- are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);
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- are willing and able to participate in an 8-week diet study that encourages preparing and eating healthy foods and snacks for 8 weeks with parental or caregiver support;
- have parental or caregiver commitment to participate in the research study;
- For this study, eligible adult parents or caregivers will be those that:
- adult parent or primary legal caregiver (greater than or equal to 25 years of age) of an enrolled adolescent;
- live with the adolescent full-time (≥80% in primary residence);
- have 1 or more metabolic risk factor(s) and/or metabolic condition(s) (e.g., overweight/obesity, hypertension, hypercholesterolemia or dyslipidemia, hyperglycemia [elevated fasting blood glucose ≥100 mg/dL] and/or prediabetes, history of gestational diabetes, polycystic ovarian syndrome, type 2 diabetes, non-alcoholic fatty liver disease);
- reside within greater Middle Tennessee area and are willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;
- are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups);
- are able to participate in a study program that encourages preparing and eating healthy foods and snacks for 8 weeks with most preparation/cooking of meals/snacks at home;
Who cannot join
- Adolescent exclusion criteria include:
- Outside of the specified age range;
- not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);
- BMI less than 95th percentile for age and gender;
- pregnant or lactating;
- no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;
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- food allergy to 3 or more food groups; dietary restrictions or medical condition that prohibits participation in a diet study;
- use of medications that cause weight loss or diabetes medications;
- active participation in a weight loss or intense lifestyle modification program;
- limited English-language proficiency;
- participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;
- adolescents who display dissenting behaviors during baseline data collection;
- adolescents who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
- Adult Parent or Caregiver exclusion criteria include:
- not parent/ or legal caregiver;
- not living in a household full-time with enrolled adolescent (less than 80% time spent away from primary residence);
- lack of metabolic condition(s) per inclusion criteria;
- special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
- limited English-language proficiency;
- participants unwilling or unable to give informed consent, accept random assignment, attend dietary counseling sessions, adhere to treatment prescription, or complete study measures;
- parent or caregivers who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Daien Sanchez, MA contact
United States1 site, 1 recruiting
- Recruiting
Vanderbilt University School of Nursing
Nashville, Tennessee, 37240
Bryn Evans, MMHC, PMP, 615-343-3290, bryn.evans@vanderbilt.edu
Gay Nell Krauss, MPA, CRA, 615-343 6070, gaynell.krauss@Vanderbilt.Edu
About this study
This study will address the following aims:
Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity.
Read more
Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention.
Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group.
Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention.
Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group.
Secondary Aims:
Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period.
Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group.
Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.
Read the detailed description
For adolescents with obesity, a healthy diet pattern is recommended as a first-line non-pharmacological treatment. Yet, despite decades of research, there is inconclusive evidence from randomized clinical trials (RCT) to support an optimal dietary pattern to treat adolescent obesity. While observational data has linked poor-quality diet patterns high in calories, fat, and refined carbohydrates to greater body adiposity in adolescents, some research suggests that dietary patterns that emphasize high-quality whole foods (e.g. Mediterranean, low-glycemic load) not only improve diet quality but can also effectively reduce body adiposity and improve metabolic outcomes (e.g., insulin resistance) without the need for calorie restrictions. However, for adolescents with obesity, adherence to a healthy diet pattern requires the involvement of the whole family, with the potential to improve diet quality and reduce body adiposity and its associated metabolic complications. Unfortunately, weaknesses of past studies include 1) a failure to intervene upon diet quality at the family level to modify adolescent dietary behaviors, and 2) a lack of consideration for how individual/family needs and social determinants of health (SDOH) impact diet adoption. To address these gaps, we will test a novel 8-week pilot RCT of a non-calorie-restricted whole foods diet adapted from the 2020-2025 Dietary Guidelines for Americans that offers a simple, customizable MyPlate Plan approach (i.e., 5 daily food group goals) focused on individual, family, cultural, and budgetary preferences. We will recruit 30 eligible adolescent (10-18 years) and parent (≥25 years) pairs to test the diet's effects on 1) adolescent body adiposity measured with dual-energy x-ray absorptiometry (DXA) to measure fat mass and anthropometry to measure weight, BMI, and waist circumference (Aim 1) and 2) adolescent and parent diet quality scores measured from dietary recalls using the 2020 Healthy Eating Index during the intervention (Aim 2). Post-intervention family focus groups will be conducted to understand how individual/family needs and preferences and SDOH may be perceived barriers or facilitators of diet adherence in families (Aim 3). Feasibility, acceptability, enrollment, retention, and diet satisfaction data will be generated to establish successful benchmarks to support future studies. Participants randomized to the intervention will receive bi- weekly food delivery, menus, and dietetic support for 8 weeks. Participants randomized to the usual care group will receive dietetic counseling on MyPlate. The successful completion of this study will result in the generation of quantitative and qualitative data to support a future R01 that will test the long-term effectiveness of a whole foods diet on obesity and metabolic outcomes, and diet sustainability in adolescents with obesity and their families.
- Conditions
- Obesity, Childhood, Diet, Healthy, Body Weight Changes
- Being tested
- Whole Foods MyPlate Group
- Medical subject headings
- Pediatric Obesity, Body Weight Changes
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Foods MyPlate GroupBehavioural
Families will receive 4-weeks of rotating menus that have been designed as a part of our preliminary work and will be adapted to support adherence with the adolescent in mind (e.g., school lunch options, on-the-go snacks). Menus and diet recommendations will align with the current macronutrient nutritional goals outlined by the 2020-2025 DGA for age-sex groups. Participants will be encouraged to eat ad libitum (i.e., as desired until full) without calorie restrictions. MyPlate will be used by participants to implement the diet. During the study, adolescents and adults in the intervention group will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs.
| Study group | Role | What they receive |
|---|---|---|
| Whole Foods Counseling Group | No intervention | Participants randomized to the "usual care" group will receive a MyPlate Plan that follows a conventional Dietary Guidelines for Americans (DGA) diet which is considered a healthy diet pattern for adolescents with obesity. This diet intervention will encourage the consumption of a whole foods "dietary patterns" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. Physical activity will be encouraged per MyPlate guidelines and will be reported on the MyPlate plan daily. At the end of each week, study personnel and/or the study RDN will follow up with the participants to review the food checklists. At this time personnel will address diet-related questions and provide guidance on diet adherence. |
| Whole Foods MyPlate Group | Experimental | Adolescents and adults randomized to the "intervention group" will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs. The 8-week intervention will consist of rotating menus (per above) and bi-weekly groceries of mostly fruits and vegetables delivered to family's homes that align with the study menus to support adherence. Receives: Behavioral: Whole Foods MyPlate Group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in adolescent body composition
Body adiposity will be measured using DXA at the VUIIS with a Hologic Horizon series W scanner (Marlborough, MA). Total body fat mass (primary outcome), trunk fat mass, lean body mass (LBM) in kg, and total body %fat will be recorded.
Measured: Baseline to 8-weeks
Secondary outcomes (6)
Changes in adolescent and adult diet quality
The 2020 Healthy Eating Index (HEI) will be used to estimate adolescent and adult diet quality scores during the study. Scores will be calculated from 3-day food diaries imputed into NDSR software. The HEI uses a scoring system of 0-100 to determine how well an individual's diet (ages ≥2 years) aligns with major DGA recommendations with a higher diet quality score indicating a healthier diet. Dietary information from 3-day food diaries will be used to estimate the baseline diet quality score.
Measured: Baseline to 8-weeks
Change in Adult Body Mass Index (BMI)
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. These categories are the same for men and women of all body types and ages. Below 18.5 : Underweight; 18.5 - 24.9: Normal or Healthy Weight; 25.0 - 29.9: Overweight; 30.0 and Above: Obese.
Measured: Baseline to 8-weeks
Change in adolescent Body Mass Index (BMI) percentiles
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI percentiles.
Measured: Baseline to 8-weeks
Change in adolescent Body Mass Index (BMI) Z Scores
Body mass index (BMI) is a person's weight in kilograms divided by the square of height in meters. BMI is interpreted using standard weight status categories. The CDC BMI-for-age charts for children above 2 years will be used to calculate BMI z-scores.
Measured: Baseline to 8-weeks
Change in adolescent and adult Waist Measurements
Waist circumference will be measured in centimeters.
Measured: Baseline to 8-weeks
Diet adherence in adolescents and adults
≥80% compliance with the diet will be considered "adherent" and will be estimated qualitatively from food diaries. The dietitian will review food checklists/diaries to assess adherence and to modify diets or support compliance.
Measured: Baseline to 8-weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2024
- Study start24 Mar 2025
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity, ChildhoodStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Responsible party
- Principal investigator, Nadia Markie Sneed, Vanderbilt University
- Investigators
- Nadia M Sneed, PhD, MSN, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06464497
- Sponsor's protocol ID
- 240866
- Status last verified
- Mar 2026
- First submitted
- 12 Jun 2024
- Last updated
- 23 Mar 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 23 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Foods for Teens: A Pilot Dietary Intervention to Reduce Body Adiposity in Adolescents With Obesity
- ClinicalTrials.gov ID
- NCT06464497
- Acronym / sponsor ID
- 240866
- Conditions
- Obesity, Childhood, Diet, Healthy, Body Weight Changes
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Collaborators
- Vanderbilt University Medical Center
- Study start
- 24 Mar 2025 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 18 Jun 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.
This study will address the following aims:
Aim 1: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on body adiposity in adolescents with obesity.
Aim 1a (Primary): Evaluate intervention effectiveness on total fat mass following the 8-week intervention.
Hypothesis 1a: Adolescents randomized to the whole foods intervention will have lower total fat mass (kg) at the 8-week follow-up than those in the control group.
Aim 1b: Evaluate intervention effectiveness on anthropometric changes following the 8-week intervention.
Hypothesis 1b: Adolescents randomized to the whole foods intervention will have lower weight, BMI-z scores and/or waist circumference at the 8-week follow-up than those in the control group.
Secondary Aims:
Aim 2: Conduct an 8-week pilot RCT to examine the effects of a whole foods diet intervention on diet quality in adolescent and parent pairs during the study period.
Hypothesis 2: Adolescents and parents randomized to the whole foods intervention will have higher diet quality scores at the 8-week follow-up than those in the control group.
Aim 3: Conduct post-intervention family focus groups to identify how individual/family needs and preferences and social determinants of health (SDOH) may be perceived barriers and/or facilitators of diet adherence to a whole foods diet pattern.
Detailed description
For adolescents with obesity, a healthy diet pattern is recommended as a first-line non-pharmacological treatment. Yet, despite decades of research, there is inconclusive evidence from randomized clinical trials (RCT) to support an optimal dietary pattern to treat adolescent obesity. While observational data has linked poor-quality diet patterns high in calories, fat, and refined carbohydrates to greater body adiposity in adolescents, some research suggests that dietary patterns that emphasize high-quality whole foods (e.g. Mediterranean, low-glycemic load) not only improve diet quality but can also effectively reduce body adiposity and improve metabolic outcomes (e.g., insulin resistance) without the need for calorie restrictions. However, for adolescents with obesity, adherence to a healthy diet pattern requires the involvement of the whole family, with the potential to improve diet quality and reduce body adiposity and its associated metabolic complications. Unfortunately, weaknesses of past studies include 1) a failure to intervene upon diet quality at the family level to modify adolescent dietary behaviors, and 2) a lack of consideration for how individual/family needs and social determinants of health (SDOH) impact diet adoption. To address these gaps, we will test a novel 8-week pilot RCT of a non-calorie-restricted whole foods diet adapted from the 2020-2025 Dietary Guidelines for Americans that offers a simple, customizable MyPlate Plan approach (i.e., 5 daily food group goals) focused on individual, family, cultural, and budgetary preferences. We will recruit 30 eligible adolescent (10-18 years) and parent (≥25 years) pairs to test the diet's effects on 1) adolescent body adiposity measured with dual-energy x-ray absorptiometry (DXA) to measure fat mass and anthropometry to measure weight, BMI, and waist circumference (Aim 1) and 2) adolescent and parent diet quality scores measured from dietary recalls using the 2020 Healthy Eating Index during the intervention (Aim 2). Post-intervention family focus groups will be conducted to understand how individual/family needs and preferences and SDOH may be perceived barriers or facilitators of diet adherence in families (Aim 3). Feasibility, acceptability, enrollment, retention, and diet satisfaction data will be generated to establish successful benchmarks to support future studies. Participants randomized to the intervention will receive bi- weekly food delivery, menus, and dietetic support for 8 weeks. Participants randomized to the usual care group will receive dietetic counseling on MyPlate. The successful completion of this study will result in the generation of quantitative and qualitative data to support a future R01 that will test the long-term effectiveness of a whole foods diet on obesity and metabolic outcomes, and diet sustainability in adolescents with obesity and their families.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Whole Foods Counseling Group | No intervention | –Participants randomized to the "usual care" group will receive a MyPlate Plan that follows a conventional Dietary Guidelines for Americans (DGA) diet which is considered a healthy diet pattern for adolescents with obesity. This diet intervention will encourage the consumption of a whole foods "dietary patterns" such as a wide variety of fruits, vegetables, proteins, seafood, dairy and whole grains. Physical activity will be encouraged per MyPlate guidelines and will be reported on the MyPlate plan daily. At the end of each week, study personnel and/or the study RDN will follow up with the participants to review the food checklists. At this time personnel will address diet-related questions and provide guidance on diet adherence. |
| Whole Foods MyPlate Group | Experimental | Behavioral: Whole Foods MyPlate GroupAdolescents and adults randomized to the "intervention group" will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs. The 8-week intervention will consist of rotating menus (per above) and bi-weekly groceries of mostly fruits and vegetables delivered to family's homes that align with the study menus to support adherence. |
Who may qualify
- Ages
- 10 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (15 listed)
- 10-18 years of age at time of initial screening;
- living at home full-time with the enrolled parent or caregiver (≥80% in primary residence);
- obesity defined as a body mass index (BMI) greater than or equal to 95th percentile for age and gender based on standardized CDC growth curves;
- reside within greater Middle Tennessee area and has enrolled parent/caregiver willing to drive to Vanderbilt University and Vanderbilt University Medical Center for study visits;
- are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy to 3 or more food groups causing anaphylaxis);
Key exclusion criteria (21 listed)
- Outside of the specified age range;
- not living in the home of the enrolled parent or caregiver full time (≥80% in primary residence);
- BMI less than 95th percentile for age and gender;
- pregnant or lactating;
- no eligible enrolled parent or caregiver or lack of parental/caregiver commitment to participate in study;
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 |
|---|---|---|
| Whole Foods MyPlate GroupFamilies will receive 4-weeks of rotating menus that have been designed as a part of our preliminary work and will be adapted to support adherence with the adolescent in mind (e.g., school lunch options, on-the-go snacks). Menus and diet recommendations will align with the current macronutrient nutritional goals outlined by the 2020-2025 DGA for age-sex groups. Participants will be encouraged to eat ad libitum (i.e., as desired until full) without calorie restrictions. MyPlate will be used by participants to implement the diet. During the study, adolescents and adults in the intervention group will receive a MyPlate Plan to support daily food group and macronutrient goals that align with the whole foods diet per caloric needs. | Behavioural | Whole Foods MyPlate Group |
Primary outcome
Change in adolescent body composition
Time frame: Baseline to 8-weeks
Body adiposity will be measured using DXA at the VUIIS with a Hologic Horizon series W scanner (Marlborough, MA). Total body fat mass (primary outcome), trunk fat mass, lean body mass (LBM) in kg, and total body %fat will be recorded.
6 secondary outcomes
Changes in adolescent and adult diet quality
Time frame: Baseline to 8-weeks
Change in Adult Body Mass Index (BMI)
Time frame: Baseline to 8-weeks
Change in adolescent Body Mass Index (BMI) percentiles
Time frame: Baseline to 8-weeks
Change in adolescent Body Mass Index (BMI) Z Scores
Time frame: Baseline to 8-weeks
Change in adolescent and adult Waist Measurements
Time frame: Baseline to 8-weeks
Diet adherence in adolescents and adults
Time frame: Baseline to 8-weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Mar 2026.
- Study websiteLink provided by the sponsor.
- Individual participant dataSharing planned: Undecided
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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.
Daien Sanchez, MA contact
Nadia M Sneed, PhD, MSN principal investigator
Vanderbilt University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Whole Foods MyPlate Group in people with Obesity, Childhood and Diet, Healthy, run by Vanderbilt University 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 15 inclusion and 21 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: looking for participants now, as of the sponsor's last update on 23 Mar 2026. 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. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Nadia M Sneed, PhD, MSN (615-343-1542, nadia.sneed@vanderbilt.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in adolescent body composition (time frame: Baseline to 8-weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 23 Mar 2026.