PreDiabetesNCT05483972
Whole Prediabetes: A Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring
A study testing Whole Prediabetes Diet Intervention in people with PreDiabetes, run by Vanderbilt University at 1 site in United States.
Trial summary
This study will address the following aims: Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years). Read more about this study
- Who is it for?
- Ages 25 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- PreDiabetes
- What is being tested?
- Whole Prediabetes Diet Intervention
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 4 Oct 2022to 25 Mar 2023
- 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 25 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- For this study, eligible adults will be those that:
- are 25 to 59 years of age at time of initial screen and identify as a parent to at least one (two max) biological child or adolescent 6-17 years;
- have a body mass index of between ≥23kg/m2 to <40kg/m2;
- have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg/dL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test [OGTT] 140 mg/dL to 199 mg/dL) reported within the last 6 months and confirmed by the participants medical records;
- have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
- are English speaking;
Show all 19Show fewer
- reside within the greater Nashville, TN area;
- are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
- are able to participate in a two-week dietary program that requires home preparation/cooking for all meals and snacks;
- For this study, eligible offspring (child(ren)/ adolescent(s)) will be those that:
- Are 6-17 years at time of initial screen;
- Have an index parent with prediabetes that is actively enrolled in the program;
- have body mass index ≥5th percentile for age and gender on standardized CDC growth curves;
- have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
- have parental commitment to participate in a two-week research study;
- are English speaking;
- reside within the greater Nashville, TN area and live at home with their index parent during duration of 2- week study;
- are without medical conditions that would limit participation in a diet-related study (e.g., tube feeding, dysphagia, severe food allergy causing anaphylaxis);
- are able to participate in a two-week dietary program that includes at least dinner and snacks provided during after-school hours;
Who cannot join
- Adult exclusion criteria include:
- adults outside the specified age range of <25 years or >59 years;
- adults whose body mass index is <23kg/m2 or those with a body mass index ≥40kg/m2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);
- are not currently undergoing routine medical supervision by a licensed healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management/treatment;
- adults actively participating in any type of weight loss program (dietary or physical activity) or those who participate in regular (≥120 minutes per week) moderate to vigorous physical activity (as requirements of the program include assessing weight change as a result of the diet);
- adults with a prior history of type 2 diabetes;
Show all 25Show fewer
- adults who are not English speaking;
- adults with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
- adults with serious mental or neurologic illness that impairs ability to consent/participate;
- women who are pregnant or nursing due to increased metabolic state requiring greater energy requirements;
- adults currently taking medications to treat diabetes or to promote weight loss;
- adults living outside the greater Nashville, TN area;
- adults with poor visual acuity (corrected vision worse than 20/50 with Rosenbaum Screener);
- adults who do not otherwise meet the eligibility criteria listed in sections above as determined by pre-screen;
- Offspring (child[ren] and adolescent[s]) exclusion criteria include:
- children/adolescents outside the specified age range of <6 years or >17 years;
- children/adolescents whose body mass index is <5th percentile for age and gender on standardized CDC growth curves;
- children/adolescents who do not have an eligible index parent participating in the study;
- children who do not have parental commitment to participate consistently for two-weeks;
- children/adolescents with a current or past diagnosis of diabetes mellitus (including prediabetes and type-2);
- children/adolescents who are not English speaking;
- children/adolescents with special dietary restrictions, food allergies, or medical conditions that prohibit participation in a diet-related study;
- children/adolescents who display dissenting behaviors during baseline data collection;
- children/adolescents actively participating in any type of weight loss program (medical or lifestyle);
- children/adolescents 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.
United States1 site
Vanderbilt University School of Nursing
Nashville, Tennessee, 37240
About this study
Official title: Whole Prediabetes: A Precision Nutrition Approach to Test the Feasibility of Delivering a Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring
This study will address the following aims:
Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years).
Read more
Aim 2: Test the feasibility, acceptability, enrollment, retention, and completion rates of a 2-week family-centered whole foods-based diet for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring 6-17 years.
Aim 3: Estimate and compare differences in baseline and 2-week body mass change (e.g., BMI, BMI percentiles and Z-scores, waist circumference) and diet quality for the index parent and their enrolled biological offspring.
Read the detailed description
This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods (e.g., whole grains, fruits, vegetables, nuts) in contrast to diet patterns with greater consumption of highly refined and ultra-processed foods are attributed to greater reductions in HbA1c and fasting plasma glucose and a reduced risk for T2D. This evidence comes primarily from prospective cohort and clinical studies of 1) adult populations without diabetes (including type 2 and pre-diabetes) and 2) adult populations with active T2D. Studies of family dietary interventions for transgenerational T2D prevention are lacking.
Studies have focused primarily on structured diet patterns such as the Mediterranean style, Vegetarian or Vegan, Dietary Approaches to Stop Hypertension (DASH), carbohydrate-restricted, and low-fat. Evidence supports that the diet patterns most effective for T2D risk reduction focused on primarily whole food consumption (e.g., Mediterranean-style, Vegetarian, and DASH). Yet, less attention has been given to studying the effectiveness of the Dietary Guidelines for American's (DGA) diet pattern which forms the basis of nutrition advice in the U.S. and is the guiding nutrition framework used for federal nutrition policy. Moreover, a benefit of the recent DGA is its customizable approach to diet.
Recognizing the importance of a whole foods structured diet and the recent shift of the Dietary Guidelines for American's DGA diet pattern towards a customizable, family-centered, whole foods approach, studies that test the effectiveness of a DGA-structured diet for T2D risk reduction should be prioritized. Before conducting efficacy and effectiveness trails, pilot data is needed to determine the feasibility and acceptability of using this family-centered diet approach in a population at "high risk" for T2D. Applying a family-lens where a transgenerational approach can be used to prevent T2D is necessary.
Therefore, this program aims are to design and test the feasibility of delivering a whole foods diet pattern using a family centered approach in a population at risk for T2D- adults with prediabetes and their "at-risk" biological offspring.
- Conditions
- PreDiabetes
- Being tested
- Whole Prediabetes Diet Intervention
- Medical subject headings
- Prediabetic State
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Whole Prediabetes Diet InterventionBehavioural
Participants will be instructed by RDN on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled adults in the study, the goal is to maintain complete diet adherence during the two-week intervention. The focus for children/adolescents will be on encouragement and exposure of the diet by the index parent and any additional household parent/guardian/caregiver. Participants will receive groceries that are tailored specifically to the prescribed diet menus/recipes for each week. Foods will be distributed using either a grocery delivery service or via participant pick-up. Each household will receive enough groceries to feed a household of four-persons for each week of the intervention.
| Study group | Role | What they receive |
|---|---|---|
| Whole Prediabetes Diet Intervention | Experimental | The diet intervention will consist of weekly food deliveries for a total of 2-weeks. The intervention will consist of a weekly individual counseling sessions led by the team's registered dietitian nutritionist (RDN). Prior to beginning the intervention, an initial individual and/or family meeting with the RDN will be scheduled. The focus of the meeting will be for the RDN to provide information about diet instruction, meal preparation/planning, and individual and family goal setting. Meetings can occur in person, via a secure zoom videoconference, or via telephone (per participant preference) and must take place with the index parent present, as they will be responsible for taking the lead of the diet intervention or relaying the information to the primary caregiver/spouse/partner in the household who is responsible for meal preparation/cooking. Child/adolescent participants will be instructed by the RDN on how to record their dietary intake (as age-appropriate) using a food diary. Receives: Behavioral: Whole Prediabetes Diet Intervention |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adult and offspring adherence to the diet program
Adherence will be assessed by the number of days the National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) is completed to record dietary intake. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.
Measured: 2 weeks
Change in offspring diet quality pre-post intervention
The Healthy Eating Index-2015 scale was calculated from collected 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool. Data was collected through Automated Self-Administered 24-hour dietary recall to calculate HEI-2015 scores. The scores range from 0 to 100, with higher scores reflecting greater adherence with dietary recommendations from the Dietary Guidelines for Americans. A score of 100 reflects high adherence and a score of 0 reflects no adherence.
Measured: Baseline to two 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 two weeks
Change in Offspring 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 two weeks
Change in Offspring 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 two weeks
Change in Adult and Offspring Waist Measurements
Waist circumference will be measured in centimeters.
Measured: Baseline to two weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2022
- Study start4 Oct 2022
- Primary completion22 Mar 2023
- Study completion25 Mar 2023
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 PreDiabetesStudies 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
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vanderbilt University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Nadia Markie Sneed, Vanderbilt University
- Investigators
- Nadia M Sneed, PhD, FNP-BC, Principal investigator, Vanderbilt University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05483972
- Sponsor's protocol ID
- 220475
- Status last verified
- Mar 2023
- First submitted
- 25 Jul 2022
- Last updated
- 29 Mar 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Sneed NM, Kelley R, Turner H, Piano MR, Dagostino C, Sellers A, Bonnet K, Schlundt D, Adams LE, Heerman WJ. The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring. Pilot Feasibility Stud. 2024 Oct 23;10(1):130. doi: 10.1186/s40814-024-01554-9.
PubMed 39444044
Study at a glance
From the registry record, last updated by the sponsor on 29 Mar 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Whole Prediabetes: A Precision Nutrition Approach to Test the Feasibility of Delivering a Family-Centered Whole Foods Diet in Adults With Prediabetes and Their Offspring
- ClinicalTrials.gov ID
- NCT05483972
- Acronym / sponsor ID
- 220475
- Conditions
- PreDiabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Vanderbilt UniversityUniversity, hospital or other
- Study start
- 4 Oct 2022 (actual)
- Primary completion
- 22 Mar 2023 (actual)
- Study completion
- 25 Mar 2023 (actual)
- First posted
- 2 Aug 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.
This study will address the following aims:
Aim 1: Design a family-centered whole foods diet adapted from the 2020-2025 DGA framework for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring (6-17 years).
Aim 2: Test the feasibility, acceptability, enrollment, retention, and completion rates of a 2-week family-centered whole foods-based diet for 8-12 families that include an index parent (25-59 years) with medically managed prediabetes and their biological offspring 6-17 years.
Aim 3: Estimate and compare differences in baseline and 2-week body mass change (e.g., BMI, BMI percentiles and Z-scores, waist circumference) and diet quality for the index parent and their enrolled biological offspring.
Detailed description
This dietary program is based on empirical evidence showing that a diet pattern that favors minimally processed and whole foods (e.g., whole grains, fruits, vegetables, nuts) in contrast to diet patterns with greater consumption of highly refined and ultra-processed foods are attributed to greater reductions in HbA1c and fasting plasma glucose and a reduced risk for T2D. This evidence comes primarily from prospective cohort and clinical studies of 1) adult populations without diabetes (including type 2 and pre-diabetes) and 2) adult populations with active T2D. Studies of family dietary interventions for transgenerational T2D prevention are lacking.
Studies have focused primarily on structured diet patterns such as the Mediterranean style, Vegetarian or Vegan, Dietary Approaches to Stop Hypertension (DASH), carbohydrate-restricted, and low-fat. Evidence supports that the diet patterns most effective for T2D risk reduction focused on primarily whole food consumption (e.g., Mediterranean-style, Vegetarian, and DASH). Yet, less attention has been given to studying the effectiveness of the Dietary Guidelines for American's (DGA) diet pattern which forms the basis of nutrition advice in the U.S. and is the guiding nutrition framework used for federal nutrition policy. Moreover, a benefit of the recent DGA is its customizable approach to diet.
Recognizing the importance of a whole foods structured diet and the recent shift of the Dietary Guidelines for American's DGA diet pattern towards a customizable, family-centered, whole foods approach, studies that test the effectiveness of a DGA-structured diet for T2D risk reduction should be prioritized. Before conducting efficacy and effectiveness trails, pilot data is needed to determine the feasibility and acceptability of using this family-centered diet approach in a population at "high risk" for T2D. Applying a family-lens where a transgenerational approach can be used to prevent T2D is necessary.
Therefore, this program aims are to design and test the feasibility of delivering a whole foods diet pattern using a family centered approach in a population at risk for T2D- adults with prediabetes and their "at-risk" biological offspring.
Study design
- Primary purpose
- Prevention
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Whole Prediabetes Diet Intervention | Experimental | Behavioral: Whole Prediabetes Diet InterventionThe diet intervention will consist of weekly food deliveries for a total of 2-weeks. The intervention will consist of a weekly individual counseling sessions led by the team's registered dietitian nutritionist (RDN). Prior to beginning the intervention, an initial individual and/or family meeting with the RDN will be scheduled. The focus of the meeting will be for the RDN to provide information about diet instruction, meal preparation/planning, and individual and family goal setting. Meetings can occur in person, via a secure zoom videoconference, or via telephone (per participant preference) and must take place with the index parent present, as they will be responsible for taking the lead of the diet intervention or relaying the information to the primary caregiver/spouse/partner in the household who is responsible for meal preparation/cooking. Child/adolescent participants will be instructed by the RDN on how to record their dietary intake (as age-appropriate) using a food diary. |
Who may qualify
- Ages
- 25 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (19 listed)
- are 25 to 59 years of age at time of initial screen and identify as a parent to at least one (two max) biological child or adolescent 6-17 years;
- have a body mass index of between ≥23kg/m2 to <40kg/m2;
- have prediabetes (based on American Diabetes Association criteria of either fasting plasma glucose of ≥100 mg/dL, HgbA1c 5.7-6.4%, or 2-hour plasma glucose during 75-g oral glucose tolerance test [OGTT] 140 mg/dL to 199 mg/dL) reported within the last 6 months and confirmed by the participants medical records;
- have no special dietary restrictions or food allergies that would prohibit consumption of a variety of foods/beverages;
- are English speaking;
Key exclusion criteria (25 listed)
- adults outside the specified age range of <25 years or >59 years;
- adults whose body mass index is <23kg/m2 or those with a body mass index ≥40kg/m2 as that degree of morbid obesity represents a different phenotype where dietary behavioral intervention alone may not be sufficient to achieve weight loss);
- are not currently undergoing routine medical supervision by a licensed healthcare provider (i.e., MD, NP, PA) for a complicated diagnosis of prediabetes that requires routine glycemic monitoring or frequent healthcare visits for management/treatment;
- adults actively participating in any type of weight loss program (dietary or physical activity) or those who participate in regular (≥120 minutes per week) moderate to vigorous physical activity (as requirements of the program include assessing weight change as a result of the diet);
- adults with a prior history of type 2 diabetes;
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 Prediabetes Diet InterventionParticipants will be instructed by RDN on how to adhere to the diet intervention and will be provided menus and recipes. For the enrolled adults in the study, the goal is to maintain complete diet adherence during the two-week intervention. The focus for children/adolescents will be on encouragement and exposure of the diet by the index parent and any additional household parent/guardian/caregiver. Participants will receive groceries that are tailored specifically to the prescribed diet menus/recipes for each week. Foods will be distributed using either a grocery delivery service or via participant pick-up. Each household will receive enough groceries to feed a household of four-persons for each week of the intervention. | Behavioural | Whole Prediabetes Diet Intervention |
Primary outcome
Adult and offspring adherence to the diet program
Time frame: 2 weeks
Adherence will be assessed by the number of days the National Cancer Institute's (NCI) automated self-administered 24-hour dietary recall (ASA24™) is completed to record dietary intake. The Automated Self-Administered 24-hour (ASA24®) Dietary Assessment Tool is a free, web-based tool. ASA24 enables multiple, automatically coded, self-administered 24-hour diet recalls and/or single or multi-day food records, also known as food diaries.
Change in offspring diet quality pre-post intervention
Time frame: Baseline to two weeks
The Healthy Eating Index-2015 scale was calculated from collected 24-hour dietary recall data collected using the ASA24 (Automated-Self Administered Recall System) a computerized dietary assessment tool. Data was collected through Automated Self-Administered 24-hour dietary recall to calculate HEI-2015 scores. The scores range from 0 to 100, with higher scores reflecting greater adherence with dietary recommendations from the Dietary Guidelines for Americans. A score of 100 reflects high adherence and a score of 0 reflects no adherence.
Change in Adult Body Mass Index (BMI)
Time frame: Baseline to two weeks
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.
Change in Offspring Body Mass Index (BMI) percentiles
Time frame: Baseline to two weeks
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.
Change in Offspring Body Mass Index (BMI) Z Scores
Time frame: Baseline to two weeks
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.
Change in Adult and Offspring Waist Measurements
Time frame: Baseline to two weeks
Waist circumference will be measured in centimeters.
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 29 Mar 2023.
- Derived from this study: PubMed 39444044Sneed NM, Kelley R, Turner H, Piano MR, Dagostino C, Sellers A, Bonnet K, Schlundt D, Adams LE, Heerman WJ. The development and testing of a single-arm feasibility and acceptability study of a whole foods diet intervention for adults with prediabetes and their offspring. Pilot Feasibility Stud. 2024 Oct 23;10(1):130. doi: 10.1186/s40814-024-01554-9.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nadia M Sneed, PhD, FNP-BC 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 Prediabetes Diet Intervention in people with PreDiabetes, 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 19 inclusion and 25 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 29 Mar 2023. 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?
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?
Adult and offspring adherence to the diet program (time frame: 2 weeks). The study lists 6 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 NCT05483972, 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 29 Mar 2023.