Diet, HealthyNCT07221045

A Food As Medicine Approach to Address Food Insecurity in Rural North Carolina

A study testing PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina in people with Diet, Healthy and Health Behavior, run by North Carolina State University at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts

Official record

Search all trials

Trial summary

Who is it for?: Ages 8 to 64 yearsHealthy volunteers can take part
Conditions the study is for: Diet, Healthy, Health Behavior, Blood Pressure
What is being tested?: PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 30 participants
Where: 1 siteUnited States
Study dates: 18 Apr 2025to 31 May 2026
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 8 to 64 years
All sexes
Healthy volunteers accepted
Child, Adult

Who may be able to join

Fluent in English or Spanish (speaking, reading, writing)
An adult (18 years of age or older) who's a parent or caregiver of a child ages 8 to 14 years old or a child ages 8 to 14 years old
Served at participating clinic in a county where the program is being implemented (Goldsboro Pediatrics, Bertie County Rural Health Association, and Roanoke Chowan Community Health in Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
Living in a county where the program is being implemented (Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
Free living to the extent they are able to receive and use a box of fresh produce and participate in direct nutrition education classes
Willing and able to provide written consent and participate in all study activities.

Who cannot join

Adults not at risk of food insecurity
Adults, who are not parents nor caregivers of a child 8 to 14 years
Adults who do not want to or could not fully participate (e.g., an adult family member with advanced kidney disease with severe dietary restrictions).

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Basheerah Enahora, PhD contact

9195159125

benahor@ncsu.edu

United States1 site, 1 recruiting

North Carolina State University
Raleigh, North Carolina, 27695
Basheerah Enahora, PhD, 9195159125, benahor@ncsu.edu
Basheerah Enahora, PhD
Recruiting

Other trials in United States

About this study

Official title: PhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina

Read the detailed description

Increasing fruit and vegetable (FV) intake, and reducing saturated fat, salt, and added sugar are central lifestyle recommendations in the Dietary Guidelines for Americans to prevent chronic disease. Yet, while diet is modifiable, numerous barriers exist for lower-resourced families to engage in healthy dietary behaviors. In particular, rural families face structural and systemic inequities, such as inadequate access to affordable healthy food. Thus, this project, PhytoRx Families, an innovative produce prescription (Prx) program, will address health disparities in rural North Carolina (NC). This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related outcomes. This study will define impact on FV intake using the ASA24 dietary recall (primary outcome) among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade). The study will also explore the impact of PhytoRxF on cardiovascular health-related outcomes (blood pressure, glycated hemoglobin (HbA1C), height, weight (BMI calculated)). Finally the study will examine the change in healthcare utilization among PhytoRxF participants.

Conditions: Diet, Healthy, Health Behavior, Blood Pressure, Diabetes Mellitus Risk, Utilization, Health Care
Being tested: PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina
Medical subject headings: Health Behavior, Patient Acceptance of Health Care

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

PhytoRx Families: A Pilot Test to Address Food Security in Rural North CarolinaOther
Also called PhytoRx Families Pilot Test
This project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade).

Study groups in NCT07221045
Study group	Role	What they receive
Pilot test participants	Experimental	Participants will be referred by healthcare providers during office visits at local clinics. Providers will refer school-aged children (8-14 year olds) or adults, who are also a caregiver for a school-aged child, who screen positive for food insecurity and will submit patient referrals to the Project Coordinator utilizing a HIPAA-compliant KiteWorks platform. Receives: Other: PhytoRx Families: A Pilot Test to Address Food Security in Rural North Carolina

What is being measured

The primary outcome is the main question the study is designed to answer.

Fruit and vegetable intake
Measured by ASA24 dietary recall
Measured: Baseline and end of study at 16 weeks

Secondary outcomes (11)

Skin carotenoids
Objective measure of fruit and vegetable intake measured by skin carotenoids, derived from a validated reflection spectroscopy device, Veggie Meter®
Measured: Baseline and end of study at 16 weeks
Diet quality
Measured by ASA24 dietary recall
Measured: Baseline and end of study at 16 weeks
Food security status
USDA 6-Item Food Security Survey. Score range is 0 to 6. Responses of "often" or "sometimes" on questions HH3 and HH4, and "yes" on AD1, AD2, and AD3 are coded as affirmative (yes). Responses of "almost every month" and "some months but not every month" on AD1a are coded as affirmative (yes). The sum of affirmative responses to the six questions in the module is the household's raw score on the scale. Food security status is assigned as follows: Raw score 0-1-High or marginal food security; Raw score 2-4-Low food security; Raw score 5-6-Very low food security
Measured: Baseline and end of study at 16 weeks
Nutrition security status
4-Item Household Nutrition Security Screener (Gretchen Swanson/Center for Nutrition \& Health Impact), Score range is 0 (if the participant selects "Always") to 4 (if the participant selects "Never"), with higher scores indicating a greater degree of Household Nutrition Security
Measured: Baseline and end of study at 16 weeks
Blood pressure
Measured by automated monitor; Omron HEM-907XL, Vernon Hills
Measured: Baseline and end of study at 16 weeks
Hemoglobin A1C
Measured by point-of-care (PoC) testing via A1C+ Now Analyzer, PTS Diagnostics
Measured: Baseline and end of study at 16 weeks
Body Mass Index
Weight in kilograms and height in meters (collected at baseline only) will be assessed by electronic scale with stadiometer, SECA 874dr scale. BMI will be calculated by dividing weight (kg) by height (m) squared
Measured: Baseline and end of study at 16 weeks
Self-efficacy for Healthy Eating
Self-efficacy for Eating Behaviors Scale. Score range from 1 (participant responds strongly disagree) to 5 (participant responds strongly agree), with higher scores indicating higher self efficacy for choosing healthy foods
Measured: Baseline and end of study at 16 weeks
Food-related Parenting Practices
Comprehensive Home Environment Survey (CHES). Measurement of social and physical home environment to assess food-related parenting practices. Scale from 1 (participant responds "Never") to 5 (participant responds "Always"), with higher scores indicating positive food-related parenting practices (ie eating meals together as a family, modeling healthy behaviors, cooking at home, involving children in the meal planning/cooking process).
Measured: Baseline and end of study at 16 weeks
Barriers and Facilitators to Fruit and Vegetable Consumption
Adapted instruments from the Family Life, Activity, Sun, Health, and Eating (FLASHE) Parent Module and the Singleton et al 2018 study to assess barriers and facilitators to fruit and vegetable consumption. Score range from 1 (participant responds "Strongly Disagree") to 5 (participant responds "Strongly Agree"), with higher scores representing more barriers to eating fruits and vegetables.
Measured: Baseline to end of study at 16 weeks
Body Mass Index-For-Age Percentile
Weight in kilograms and height in meters (collected at baseline only) will be assessed by electronic scale with stadiometer, SECA 874dr scale. BMI will be calculated by dividing weight (kg) by height (m) squared, then plotted on a growth chart.
Measured: Baseline and end of study at 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

18 Apr 202531 May 2026

First posted27 Oct 2025
Study start18 Apr 2025
Primary completion31 May 2026 (estimated)
Study completion31 May 2026 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (21)Papers the sponsor has linked to this study.
Other trials for Diet, HealthyStudies 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: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 30 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT07221045
Sponsor's protocol ID: 27407
Status last verified: Oct 2025
First submitted: 20 Oct 2025
Last updated: 27 Oct 2025
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No: Data will be reported in aggregate for publication in academic journals (means and standard deviations). No identifying information will be reported in any publications arising from this research. No direct personal identifiers will be used in any published research.

Publications

Norris K, Jilcott Pitts S, Reis H, Haynes-Maslow L. A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. Nutrients. 2023 Aug 5;15(15):3464. doi: 10.3390/nu15153464.
PubMed 37571400
Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec.
PubMed 33521534
Heasley C, Clayton B, Muileboom J, Schwanke A, Rathnayake S, Richter A, Little M. "I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Arch Public Health. 2021 Jul 23;79:135. doi: 10.1186/s13690-021-00657-6. eCollection 2021.
PubMed 34301335
Fischer L, Bodrick N, Mackey ER, McClenny A, Dazelle W, McCarron K, Mork T, Farmer N, Haemer M, Essel K. Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. Nutrients. 2022 May 10;14(10):2006. doi: 10.3390/nu14102006.
PubMed 35631144
Harkin N, Johnston E, Mathews T, Guo Y, Schwartzbard A, Berger J, Gianos E. Physicians' Dietary Knowledge, Attitudes, and Counseling Practices: The Experience of a Single Health Care Center at Changing the Landscape for Dietary Education. Am J Lifestyle Med. 2018 Nov 23;13(3):292-300. doi: 10.1177/1559827618809934. eCollection 2019 May-Jun.
PubMed 31105493
Rahman V. Time to Revamp Nutrition Education for Physicians. Perm J. 2019;23:19-052. doi: 10.7812/TPP/19.052. Epub 2019 Aug 19.
PubMed 31496507
Wolfson JA, Ramsing R, Richardson CR, Palmer A. Barriers to healthy food access: Associations with household income and cooking behavior. Prev Med Rep. 2019 Jan 31;13:298-305. doi: 10.1016/j.pmedr.2019.01.023. eCollection 2019 Mar.
PubMed 30792944
Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. 2018 Feb;50(2):148-172.e1. doi: 10.1016/j.jneb.2017.08.004. Epub 2017 Sep 25.
PubMed 28958671
Levi R, Schwartz M, Campbell E, Martin K, Seligman H. Nutrition standards for the charitable food system: challenges and opportunities. BMC Public Health. 2022 Mar 14;22(1):495. doi: 10.1186/s12889-022-12906-6.
PubMed 35287656
Lutfiyya MN, Chang LF, Lipsky MS. A cross-sectional study of US rural adults' consumption of fruits and vegetables: do they consume at least five servings daily? BMC Public Health. 2012 Jun 1;12:280. doi: 10.1186/1471-2458-12-280.
PubMed 22490063
Laraia BA. Food insecurity and chronic disease. Adv Nutr. 2013 Mar 1;4(2):203-12. doi: 10.3945/an.112.003277.
PubMed 23493536
Backonja U, Park S, Kurre A, Yudelman H, Heindel S, Schultz M, Whitman G, Turner AM, Marchak NT, Bekemeier B. Supporting rural public health practice to address local-level social determinants of health across Northwest states: Development of an interactive visualization dashboard. J Biomed Inform. 2022 May;129:104051. doi: 10.1016/j.jbi.2022.104051. Epub 2022 Mar 19.
PubMed 35318149
Byker Shanks C, Andress L, Hardison-Moody A, Jilcott Pitts S, Patton-Lopez M, Prewitt TE, Dupuis V, Wong K, Kirk-Epstein M, Engelhard E, Hake M, Osborne I, Hoff C, Haynes-Maslow L. Food Insecurity in the Rural United States: An Examination of Struggles and Coping Mechanisms to Feed a Family among Households with a Low-Income. Nutrients. 2022 Dec 9;14(24):5250. doi: 10.3390/nu14245250.
PubMed 36558409
Schipper HS, de Ferranti S. Cardiovascular Risk Assessment and Management for Pediatricians. Pediatrics. 2022 Dec 1;150(6):e2022057957. doi: 10.1542/peds.2022-057957.
PubMed 36321395
Harrington RA, Califf RM, Balamurugan A, Brown N, Benjamin RM, Braund WE, Hipp J, Konig M, Sanchez E, Joynt Maddox KE. Call to Action: Rural Health: A Presidential Advisory From the American Heart Association and American Stroke Association. Circulation. 2020 Mar 10;141(10):e615-e644. doi: 10.1161/CIR.0000000000000753. Epub 2020 Feb 10.
PubMed 32078375

Interested in taking part?

Basheerah Enahora, PhD

9195159125

benahor@ncsu.edu

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 27 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: PhytoRx Families: A Pilot Test Study to Address Food Security and Fruit and Vegetable Intake in Rural North Carolina
ClinicalTrials.gov ID: NCT07221045
Acronym / sponsor ID: 27407
Conditions: Diet, Healthy, Health Behavior, Blood Pressure, Diabetes Mellitus Risk, Utilization, Health Care
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 30 participants (estimated)
Lead sponsor: North Carolina State UniversityUniversity, hospital or other
Collaborators: East Carolina University
Study start: 18 Apr 2025 (actual)
Primary completion: 31 May 2026 (estimated)
Study completion: 31 May 2026 (estimated)
First posted: 27 Oct 2025 (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.

Detailed description

Study design

Primary purpose: Prevention
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
Pilot test participants	Experimental	Other: PhytoRx Families: A Pilot Test to Address Food Security in Rural North CarolinaParticipants will be referred by healthcare providers during office visits at local clinics. Providers will refer school-aged children (8-14 year olds) or adults, who are also a caregiver for a school-aged child, who screen positive for food insecurity and will submit patient referrals to the Project Coordinator utilizing a HIPAA-compliant KiteWorks platform.

Who may qualify

Ages: 8 to 64 years
Sex: All
Healthy volunteers: Accepted
Age groups: Child, Adult

Key inclusion criteria (6 listed)

Fluent in English or Spanish (speaking, reading, writing)
An adult (18 years of age or older) who's a parent or caregiver of a child ages 8 to 14 years old or a child ages 8 to 14 years old
Served at participating clinic in a county where the program is being implemented (Goldsboro Pediatrics, Bertie County Rural Health Association, and Roanoke Chowan Community Health in Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
Living in a county where the program is being implemented (Bertie, Halifax, Lenoir, Northampton, or Wayne Counties)
Free living to the extent they are able to receive and use a box of fresh produce and participate in direct nutrition education classes

Key exclusion criteria (3 listed)

Adults not at risk of food insecurity
Adults, who are not parents nor caregivers of a child 8 to 14 years
Adults who do not want to or could not fully participate (e.g., an adult family member with advanced kidney disease with severe dietary restrictions).

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
PhytoRx Families: A Pilot Test to Address Food Security in Rural North CarolinaAlso: PhytoRx Families Pilot TestThis project will pilot test and explore the impact of PhytoRx Families (PhtyoRxF) on nutrition-related, health-related, and healthcare utilization outcomes among n=30 adults and school-aged children (adult-child dyads; children 8-14 year olds, 2nd-9th grade).	Other	Pilot test participants

Primary outcome

Fruit and vegetable intake
Time frame: Baseline and end of study at 16 weeks
Measured by ASA24 dietary recall

11 secondary outcomes

Skin carotenoids
Time frame: Baseline and end of study at 16 weeks
Diet quality
Time frame: Baseline and end of study at 16 weeks
Food security status
Time frame: Baseline and end of study at 16 weeks
Nutrition security status
Time frame: Baseline and end of study at 16 weeks
Blood pressure
Time frame: Baseline and end of study at 16 weeks
Hemoglobin A1C
Time frame: Baseline and end of study at 16 weeks
Body Mass Index
Time frame: Baseline and end of study at 16 weeks
Self-efficacy for Healthy Eating
Time frame: Baseline and end of study at 16 weeks
Food-related Parenting Practices
Time frame: Baseline and end of study at 16 weeks
Barriers and Facilitators to Fruit and Vegetable Consumption
Time frame: Baseline to end of study at 16 weeks
Body Mass Index-For-Age Percentile
Time frame: Baseline and end of study at 16 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 27 Oct 2025.
Background: PubMed 37571400Norris K, Jilcott Pitts S, Reis H, Haynes-Maslow L. A Systematic Literature Review of Nutrition Interventions Implemented to Address Food Insecurity as a Social Determinant of Health. Nutrients. 2023 Aug 5;15(15):3464. doi: 10.3390/nu15153464.
Background: PubMed 33521534Kerr D, Barua S, Glantz N, Conneely C, Kujan M, Bevier W, Larez A, Sabharwal A. Farming for life: impact of medical prescriptions for fresh vegetables on cardiometabolic health for adults with or at risk of type 2 diabetes in a predominantly Mexican-American population. BMJ Nutr Prev Health. 2020 Oct 5;3(2):239-246. doi: 10.1136/bmjnph-2020-000133. eCollection 2020 Dec.
Background: PubMed 34301335Heasley C, Clayton B, Muileboom J, Schwanke A, Rathnayake S, Richter A, Little M. "I was eating more fruits and veggies than I have in years": a mixed methods evaluation of a fresh food prescription intervention. Arch Public Health. 2021 Jul 23;79:135. doi: 10.1186/s13690-021-00657-6. eCollection 2021.
Background: PubMed 35631144Fischer L, Bodrick N, Mackey ER, McClenny A, Dazelle W, McCarron K, Mork T, Farmer N, Haemer M, Essel K. Feasibility of a Home-Delivery Produce Prescription Program to Address Food Insecurity and Diet Quality in Adults and Children. Nutrients. 2022 May 10;14(10):2006. doi: 10.3390/nu14102006.
Background: PubMed 31105493Harkin N, Johnston E, Mathews T, Guo Y, Schwartzbard A, Berger J, Gianos E. Physicians' Dietary Knowledge, Attitudes, and Counseling Practices: The Experience of a Single Health Care Center at Changing the Landscape for Dietary Education. Am J Lifestyle Med. 2018 Nov 23;13(3):292-300. doi: 10.1177/1559827618809934. eCollection 2019 May-Jun.
Background: PubMed 31496507Rahman V. Time to Revamp Nutrition Education for Physicians. Perm J. 2019;23:19-052. doi: 10.7812/TPP/19.052. Epub 2019 Aug 19.
Background: PubMed 30792944Wolfson JA, Ramsing R, Richardson CR, Palmer A. Barriers to healthy food access: Associations with household income and cooking behavior. Prev Med Rep. 2019 Jan 31;13:298-305. doi: 10.1016/j.pmedr.2019.01.023. eCollection 2019 Mar.
Background: PubMed 28958671Reicks M, Kocher M, Reeder J. Impact of Cooking and Home Food Preparation Interventions Among Adults: A Systematic Review (2011-2016). J Nutr Educ Behav. 2018 Feb;50(2):148-172.e1. doi: 10.1016/j.jneb.2017.08.004. Epub 2017 Sep 25.
Background: PubMed 35287656Levi R, Schwartz M, Campbell E, Martin K, Seligman H. Nutrition standards for the charitable food system: challenges and opportunities. BMC Public Health. 2022 Mar 14;22(1):495. doi: 10.1186/s12889-022-12906-6.
Background: PubMed 22490063Lutfiyya MN, Chang LF, Lipsky MS. A cross-sectional study of US rural adults' consumption of fruits and vegetables: do they consume at least five servings daily? BMC Public Health. 2012 Jun 1;12:280. doi: 10.1186/1471-2458-12-280.
Background: PubMed 23493536Laraia BA. Food insecurity and chronic disease. Adv Nutr. 2013 Mar 1;4(2):203-12. doi: 10.3945/an.112.003277.
Background: PubMed 35318149Backonja U, Park S, Kurre A, Yudelman H, Heindel S, Schultz M, Whitman G, Turner AM, Marchak NT, Bekemeier B. Supporting rural public health practice to address local-level social determinants of health across Northwest states: Development of an interactive visualization dashboard. J Biomed Inform. 2022 May;129:104051. doi: 10.1016/j.jbi.2022.104051. Epub 2022 Mar 19.
Individual participant dataSharing planned: No. Data will be reported in aggregate for publication in academic journals (means and standard deviations). No identifying information will be reported in any publications arising from this research. No direct personal identifiers will be used in any published research.

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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.

Basheerah Enahora, PhD contact

9195159125

benahor@ncsu.edu

Basheerah Enahora, PhD principal investigator

North Carolina State University

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

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 6 inclusion and 3 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 27 Oct 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 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 Basheerah Enahora, PhD (9195159125, benahor@ncsu.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Fruit and vegetable intake (time frame: Baseline and end of study at 16 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 NCT07221045, which also lists 21 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 27 Oct 2025.