HeightNCT06704178
A Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
A study testing NuBest Tall Growth Protein Powder in people with Height and Cognitive Function, run by NuBest at 1 site in United States.
Trial summary
A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified… Read more about this study
- Who is it for?
- Ages 10 to 16 yearsHealthy volunteers can take part
- Conditions the study is for
- Height, Cognitive Function, Weight Gain
- What is being tested?
- NuBest Tall Growth Protein Powder
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Jun 2024to 16 Feb 2025
- Phase
- Interventional
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 16 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels.
- Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study.
- Parents willing to weigh and measure the height of their child throughout the study.
- Generally healthy - do not have any uncontrolled chronic disease.
Who cannot join
- Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Is undergoing or planning to undergo significant medical procedures in the next six months.
- A history of severe allergic reactions, including but not limited to any of the product's ingredients.
- Any child with a dairy allergy or lactose intolerance.
- Has undergone any surgeries or invasive treatments in the last six months.
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- Has had any major illness in the last three months.
- Having any planned invasive medical procedures during the study period.
- Currently participating in any other clinical study.
- Unwilling to follow the study protocol.
- Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD).
- Any child currently taking or have taken in the last 3 months any prescription medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or Ritalin).
- Any child that is a 'fussy' eater or who the parent suspects may not tolerate consuming the test product daily for six months.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.
- Conditions
- Height, Cognitive Function, Weight Gain
- Being tested
- NuBest Tall Growth Protein Powder, Placebo Powder
- Keywords
- Dietary Supplement, Growth and Development
- Medical subject headings
- Weight Gain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
NuBest Tall Growth Protein PowderDietary supplement
NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes.
Placebo PowderDietary supplement
The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients.
| Study group | Role | What they receive |
|---|---|---|
| Intervention Arm | Experimental | Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months. Receives: Dietary Supplement: NuBest Tall Growth Protein Powder |
| Placebo Arm | Placebo comparator | Participants in this arm will take a placebo product daily for 6 months. Receives: Dietary Supplement: Placebo Powder |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change Mean Percentile Score in Double Trouble
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline and Month 6
IChange Mean Percentile Score in Feature Match
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline and Month 6
Change Mean Percentile Score in Grammatical Reasoning
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Digit Span
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Token Search
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Secondary outcomes (67)
Increase in Height
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Measured: Baseline, Month 2, Month 4, and Month 6
Changes in Weight
Weight measurement will be taken using a FitBit Smart Scale. Changes in weight will be analyzed across the groups.
Measured: Baseline, Month 2, Month 4, and Month 6
Changes in Overall Health as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of the Child's Health in the Future.
This parameter was assessed using a parent-completed questionnaire, with the question "I expect my child will have a very healthy life". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
This parameter was assessed using a parent-completed questionnaire, whereby parents were asked to rate their child's overall health in the past 4 weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Much worse," 5 = "Much Better"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Child's Energy Levels as Reported by Parents
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Completing High-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). An increase in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Limitations When Bending, Lifting, or Stooping.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Limitations During the Completion of Schoolwork or Activities.
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children.
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter.
Measured: Monthly from Baseline to Month 6
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
This parameter was assessed within the NuBest group using a child-completed cognitive assessment. Participants received a percentile score ranging from 1 to 100, with higher scores indicating better cognitive function. The overall score at each timepoint reflects performance on the cognitive test.
Measured: Baseline to Month 6
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Measured: Baseline to Month 6
Increase in Height - Nubest Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Measured: Baseline to Month 6
Increase in Height - Placebo Group Only (Within-Group Analysis)
Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Measured: Baseline to Month 6
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Measured: Baseline to Month 6
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Weight measurement will be taken using a FitBit Smart Scale.
Measured: Baseline to Month 6
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6.
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6.
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6.
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6.
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Bending, Lifting, or Stooping - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations During the Completion of Schoolwork or Activities - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - NuBest Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the NuBest group only.
Measured: Monthly from Baseline to Month 6
Changes in Overall Health as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Parents were required to rate their child's overall health in the past four weeks. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of the Child's Health in the Future - Placebo Group Only (Within-Group Analysis)
Hide Description:
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Parents' Perception of the Change in Child's Health Compared to One Month Ago - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Child's Energy Levels as Reported by Parents - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where higher scores indicate better outcomes (e.g., 1 = "Very Poor" ," 5 = "Excellent"). An increase in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Completing High-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations When Bending, Lifting, or Stooping - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations in the Kind of Schoolwork or Activities Undertaken - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations in the Amount of Time Spent Completing Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Changes in Limitations During the Completion of Schoolwork or Activities - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where lower scores indicate better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "My child seems less healthy than other children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the Placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "When something is going around my child usually catches it". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. The parents were asked to respond to the following statement "I worry more about my child's health than other parents do their children". Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet - Placebo Group Only (Within-Group Analysis)
This parameter was assessed using a parent-completed questionnaire. Responses were collected using a 5-point Likert scale with textual anchors and transformed into a numerical scale from 1 to 5, where a decrease in score indicates better outcomes (e.g., 1 = "Never," 5 = "Always"). A decrease in the mean score is associated with improvement in this parameter. This analysis summarizes the mean score at each timepoint for the placebo group only.
Measured: Monthly from Baseline to Month 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Nov 2024
- Study start12 Jun 2024
- Primary completion16 Feb 2025
- Study completion16 Feb 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for HeightStudies 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
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- A randomized, double-blind, placebo-controlled, two-arm trial.
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (actual)
Sponsor and investigators
- Lead sponsor
- NuBest
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06704178
- Sponsor's protocol ID
- 20424
- Status last verified
- Jul 2025
- First submitted
- 7 Aug 2024
- Last updated
- 24 Jul 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
- ClinicalTrials.gov ID
- NCT06704178
- Acronym / sponsor ID
- 20424
- Conditions
- Height, Cognitive Function, Weight Gain
- Keywords
- Dietary Supplement, Growth and Development
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (actual)
- Lead sponsor
- NuBestIndustry (pharma, biotech, devices)
- Collaborators
- Citruslabs
- Study start
- 12 Jun 2024 (actual)
- Primary completion
- 16 Feb 2025 (actual)
- Study completion
- 16 Feb 2025 (actual)
- First posted
- 26 Nov 2024 (actual)
- Results
- Posted 24 Jul 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.
Study design
- Primary purpose
- Health services research
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- A randomized, double-blind, placebo-controlled, two-arm trial.
| Arm | Type | Receives |
|---|---|---|
| Intervention Arm | Experimental | Dietary Supplement: NuBest Tall Growth Protein PowderParticipants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months. |
| Placebo Arm | Placebo comparator | Dietary Supplement: Placebo PowderParticipants in this arm will take a placebo product daily for 6 months. |
Who may qualify
- Ages
- 10 to 16 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels.
- Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study.
- Parents willing to weigh and measure the height of their child throughout the study.
- Generally healthy - do not have any uncontrolled chronic disease.
Key exclusion criteria (13 listed)
- Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia.
- Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
- Is undergoing or planning to undergo significant medical procedures in the next six months.
- A history of severe allergic reactions, including but not limited to any of the product's ingredients.
- Any child with a dairy allergy or lactose intolerance.
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 |
|---|---|---|
| NuBest Tall Growth Protein PowderNuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes. | Dietary supplement | Intervention Arm |
| Placebo PowderThe placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients. | Dietary supplement | Placebo Arm |
Primary outcome
Change Mean Percentile Score in Double Trouble
Time frame: Baseline and Month 6
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
IChange Mean Percentile Score in Feature Match
Time frame: Baseline and Month 6
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Change Mean Percentile Score in Grammatical Reasoning
Time frame: Baseline to Month 6
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Change Mean Percentile Score in Digit Span
Time frame: Baseline to Month 6
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
Change Mean Percentile Score in Token Search
Time frame: Baseline to Month 6
The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.
67 secondary outcomes
Increase in Height
Time frame: Baseline, Month 2, Month 4, and Month 6
Changes in Weight
Time frame: Baseline, Month 2, Month 4, and Month 6
Changes in Overall Health as Reported by Parents
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of the Child's Health in the Future.
Time frame: Monthly from Baseline to Month 6
Parents' Perception of the Change in Child's Health Compared to One Month Ago.
Time frame: Monthly from Baseline to Month 6
Change in Child's Energy Levels as Reported by Parents
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing High-Intensity Activity
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Walking 100 Meters or Climbing a Flight of Stairs
Time frame: Monthly from Baseline to Month 6
Change in Limitations When Bending, Lifting, or Stooping.
Time frame: Monthly from Baseline to Month 6
Change in Limitations in the Kind of Schoolwork or Activities Undertaken.
Time frame: Monthly from Baseline to Month 6
Change in Limitations in the Amount of Time Spent Completing Schoolwork or Activities.
Time frame: Monthly from Baseline to Month 6
Change in Limitations During the Completion of Schoolwork or Activities.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Health Compared to Other Children.
Time frame: Monthly from Baseline to Month 6
Change in Parents' Perception of Child's Immunity
Time frame: Monthly from Baseline to Month 6
Change in Parents' Worry About Child's Health
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Stomach Aches
Time frame: Monthly from Baseline to Month 6
Change in Parent-reported Frequency of Child's Difficulty Going to the Toilet
Time frame: Monthly from Baseline to Month 6
Change Mean Percentile Score in Double Trouble - NuBest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Feature Match - NuBest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning Match - NuBest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Digit Span - NuBest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Token Search - NuBest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Double Trouble - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Feature Match - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Grammatical Reasoning - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Digit Span - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Change Mean Percentile Score in Token Search - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Increase in Height - Nubest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Increase in Height - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Changes in Weight - Nubest Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Changes in Weight - Placebo Group Only (Within-Group Analysis)
Time frame: Baseline to Month 6
Changes in Overall Health as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6.
Change in Parents' Perception of the Child's Health in the Future - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6.
Parents' Perception of the Change in Child's Health Compared to One Month Ago - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6.
Change in Child's Energy Levels as Reported by Parents - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6.
Changes in Limitations When Completing High-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Completing Moderate-Intensity Activity - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6
Changes in Limitations When Moving Around - NuBest Group Only (Within-Group Analysis)
Time frame: Monthly from Baseline to Month 6
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing NuBest Tall Growth Protein Powder in people with Height and Cognitive Function, run by NuBest 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 4 inclusion and 13 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 24 Jul 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. 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?
Yes. Results are posted in the registry (first posted 24 Jul 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Change Mean Percentile Score in Double Trouble (time frame: Baseline and Month 6). The study lists 5 primary outcomes in all. 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 24 Jul 2025.