Growth DisordersPhase 1/2NCT06329388
Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
A Phase 1/2 study testing TruHeight Growth Protein Shake in people with Growth Disorders and Dietary Exposure, run by TruHeight Vitamins at 1 site in United States.
Trial summary
This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen… Read more about this study
- Who is it for?
- Ages 4 to 17 yearsHealthy volunteers can take part
- Conditions the study is for
- Growth Disorders, Dietary Exposure, Child Development
- What is being tested?
- TruHeight Growth Protein Shake
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteUnited States
- Study dates
- 18 Jan 2023to 11 Aug 2023
- Phase
- Phase 1/2
- 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 4 to 17 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Children aged 4-17 years old
- At or below the 50th percentile for height according to CDC growth charts
- Able to consume the protein shake
- Willing to maintain their regular diet throughout the study
Who cannot join
- Known allergies to ingredients in the protein shake
- Currently receiving growth hormone therapy
- Any medical condition that can affect growth or requires special diet
Trial locations and contacts
1 site in 1 country.
United States1 site
SF Research Institute
San Francisco, California, 94127
About this study
Official title: A Six-Month Randomized Controlled Pilot Study Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device.
Read the detailed description
This single-center pilot clinical trial was conducted for TruHeight to determine the effect of oral protein supplement (Growth Protein Shake-GPS) versus control on growth patterns in children. The hypothesis posits that GPS protein supplementation will improve growth patterns as assessed by the concentration of collagen X in the urine, height as measured by a stadiometer, as well as weight and body composition as measured by an INBODY device in six months.
The oral supplement was provided in powder form, which could be mixed with water before consumption.
Participants were recruited from the SF RESEARCH INSTITUTE database and through advertisements on social media and public places. Initial attendance at SF RESEARCH INSTITUTE marked the baseline study visit, where subjects underwent screening for eligibility based on the Inclusion and Exclusion Criteria. Upon meeting qualification criteria, enrollees were assigned a subject number sequentially as they joined the study. A total of 32 subjects, aged 4-17 years, embarked on the study, targeting a completion cohort of 20. Randomization into either the treatment/supplement group or control group occurred via a computer-generated code.
The trial comprised three study visits (SV) over a 6-month period. Measurements of height, weight, fat mass, and lean body mass took place at baseline (SV1), 3 months ± 5 days (SV2), and 6 months ± 5 days (SV3). Urine samples collected at SV1 and SV3 underwent laboratory analysis for type X collagen content. Depending on the group assignment, a dietary or consumer perception questionnaire was provided to be completed by the participant or the participant's guardian at baseline, SV2, and SV3. Treatment group participants or their guardians received a log form to document supplement intake at home. Maintenance of regular diet throughout the study was mandatory for all participants.
Instructions for subjects in the treatment/supplement group were as follows:
Mix and consume two (2) scoops of the dietary supplement with 12-16 fluid oz of water daily, five times per week, for 6 months. The investigator initiated follow-up calls to subjects or their guardians on day 45 (between SV1 and SV2) and day 120 (between SV2 and SV3) to assess compliance with the study protocol.
- Conditions
- Growth Disorders, Dietary Exposure, Child Development, Bone Development Abnormal, Body Weight, Child Malnutrition
- Being tested
- TruHeight Growth Protein Shake
- Keywords
- Children's Growth Patterns, Oral Protein Supplement, Pediatric Nutrition, Growth Supplements, Height Increase, Type X Collagen, Body Composition Analysis, Dietary Intervention, Nutritional Status in Children, Randomized Controlled Trial (RCT), Child Development, INBODY Device, Safety and Tolerability of Protein Shakes, Bone Growth Markers, Nutritional Supplements and Child Growth, TruHeight
- Medical subject headings
- Growth Disorders, Body Weight, Child Nutrition Disorders
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TruHeight Growth Protein ShakeDietary supplement
Participants will be administered two scoops of TruHeight Growth Protein Shake, mixed with 12-16 fluid ounces of water, once daily, five times per week for six months. The supplement is intended to support growth patterns in children by providing essential nutrients that contribute to bone development and overall growth.
| Study group | Role | What they receive |
|---|---|---|
| Treatment - Oral Protein Supplement | Experimental | Participants in this arm will receive the TruHeight Growth Protein Shake. Each serving consists of two scoops of the supplement powder mixed with 12-16 fluid ounces of water. The regimen is once daily, five times per week, for a duration of six months. Receives: Dietary Supplement: TruHeight Growth Protein Shake |
| Control - No Supplement | No intervention | Participants in this arm will not receive the oral protein supplement but will continue their regular diet. They serve as a comparison group to evaluate the effects of the TruHeight Growth Protein Shake administered to the treatment group. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Height
The primary measure is the difference in children's height measured by a stadiometer from baseline to the end of the study at six months.
Measured: 6 months
Secondary outcomes (3)
Change in Type X Collagen Concentration in Urine
Measure the difference in Type X collagen concentration in urine samples from baseline to the end of the study to assess bone growth.
Measured: Baseline and 6 months
Change in Body Composition
Evaluate the difference in body composition, including fat mass and lean body mass percentage, using the INBODY device from baseline to the end of the study.
Measured: Baseline, 3 months, and 6 months
Incidence of Adverse Events
Monitor and record any adverse events experienced by participants throughout the study duration.
Measured: Throughout the study period of 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start18 Jan 2023
- Primary completion7 Jul 2023
- Study completion11 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Growth DisordersStudies 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group).
- Masking
- None (open label)
- Enrolment
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- TruHeight Vitamins
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- San Francisco Research Institute
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06329388
- Sponsor's protocol ID
- CSD-SFRI-013
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 26 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The study proposes to share individual participant data that underlie the results reported in an article after deidentification (text, tables, figures, and appendices).
Study at a glance
From the registry record, last updated by the sponsor on 26 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Six-Month Randomized Controlled Pilot Study Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
- ClinicalTrials.gov ID
- NCT06329388
- Acronym / sponsor ID
- CSD-SFRI-013
- Conditions
- Growth Disorders, Dietary Exposure, Child Development, Bone Development Abnormal, Body Weight, Child Malnutrition
- Keywords
- Children's Growth Patterns, Oral Protein Supplement, Pediatric Nutrition, Growth Supplements, Height Increase, Type X Collagen, Body Composition Analysis, Dietary Intervention
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 32 participants (actual)
- Lead sponsor
- TruHeight VitaminsIndustry (pharma, biotech, devices)
- Collaborators
- San Francisco Research Institute
- Study start
- 18 Jan 2023 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 11 Aug 2023 (actual)
- First posted
- 25 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This single-center, randomized controlled pilot study aims to evaluate the efficacy of TruHeight Growth Protein Shake on improving growth patterns in children aged 4-17 years. Over six months, participants will consume the protein shake daily, five times a week, with outcomes measured in terms of type X collagen concentration in urine, height via a stadiometer, and body composition using an INBODY device.
Detailed description
This single-center pilot clinical trial was conducted for TruHeight to determine the effect of oral protein supplement (Growth Protein Shake-GPS) versus control on growth patterns in children. The hypothesis posits that GPS protein supplementation will improve growth patterns as assessed by the concentration of collagen X in the urine, height as measured by a stadiometer, as well as weight and body composition as measured by an INBODY device in six months.
The oral supplement was provided in powder form, which could be mixed with water before consumption.
Participants were recruited from the SF RESEARCH INSTITUTE database and through advertisements on social media and public places. Initial attendance at SF RESEARCH INSTITUTE marked the baseline study visit, where subjects underwent screening for eligibility based on the Inclusion and Exclusion Criteria. Upon meeting qualification criteria, enrollees were assigned a subject number sequentially as they joined the study. A total of 32 subjects, aged 4-17 years, embarked on the study, targeting a completion cohort of 20. Randomization into either the treatment/supplement group or control group occurred via a computer-generated code.
The trial comprised three study visits (SV) over a 6-month period. Measurements of height, weight, fat mass, and lean body mass took place at baseline (SV1), 3 months ± 5 days (SV2), and 6 months ± 5 days (SV3). Urine samples collected at SV1 and SV3 underwent laboratory analysis for type X collagen content. Depending on the group assignment, a dietary or consumer perception questionnaire was provided to be completed by the participant or the participant's guardian at baseline, SV2, and SV3. Treatment group participants or their guardians received a log form to document supplement intake at home. Maintenance of regular diet throughout the study was mandatory for all participants.
Instructions for subjects in the treatment/supplement group were as follows:
Mix and consume two (2) scoops of the dietary supplement with 12-16 fluid oz of water daily, five times per week, for 6 months. The investigator initiated follow-up calls to subjects or their guardians on day 45 (between SV1 and SV2) and day 120 (between SV2 and SV3) to assess compliance with the study protocol.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group).
| Arm | Type | Receives |
|---|---|---|
| Treatment - Oral Protein Supplement | Experimental | Dietary Supplement: TruHeight Growth Protein ShakeParticipants in this arm will receive the TruHeight Growth Protein Shake. Each serving consists of two scoops of the supplement powder mixed with 12-16 fluid ounces of water. The regimen is once daily, five times per week, for a duration of six months. |
| Control - No Supplement | No intervention | –Participants in this arm will not receive the oral protein supplement but will continue their regular diet. They serve as a comparison group to evaluate the effects of the TruHeight Growth Protein Shake administered to the treatment group. |
Who may qualify
- Ages
- 4 to 17 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- Children aged 4-17 years old
- At or below the 50th percentile for height according to CDC growth charts
- Able to consume the protein shake
- Willing to maintain their regular diet throughout the study
Key exclusion criteria (3 listed)
- Known allergies to ingredients in the protein shake
- Currently receiving growth hormone therapy
- Any medical condition that can affect growth or requires special diet
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 |
|---|---|---|
| TruHeight Growth Protein ShakeParticipants will be administered two scoops of TruHeight Growth Protein Shake, mixed with 12-16 fluid ounces of water, once daily, five times per week for six months. The supplement is intended to support growth patterns in children by providing essential nutrients that contribute to bone development and overall growth. | Dietary supplement | Treatment - Oral Protein Supplement |
Primary outcome
Change in Height
Time frame: 6 months
The primary measure is the difference in children's height measured by a stadiometer from baseline to the end of the study at six months.
3 secondary outcomes
Change in Type X Collagen Concentration in Urine
Time frame: Baseline and 6 months
Change in Body Composition
Time frame: Baseline, 3 months, and 6 months
Incidence of Adverse Events
Time frame: Throughout the study period of 6 months
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 26 Mar 2024.
- Wikipedia contributors. (2023). Stadiometer. In WikipediaLink provided by the sponsor.
- Innovative Research. (n.d.). Human Collagen Type X ELISA KitLink provided by the sponsor.
- Gudmann, N., \& Karsdal, M. (2016). Type X Collagen. In Elsevier eBooks (pp. 73-76)Link provided by the sponsor.
- Voss, L. D., Bailey, B. J., Cumming, K., Wilkin, T. J., \& Betts, P. R. (1990). The reliability of height measurement (the Wessex Growth Study). Archives of Disease in Childhood, 65(12), 1340-1344Link provided by the sponsor.
- Voss, L. D., \& Wilkin, T. J. (1991). The reliability of height and height velocity in the assessment of growth (the Wessex Growth Study). Archives of Disease in Childhood, 66(8), 833-837Link provided by the sponsor.
- Van den Broeck, J., Hokken-Koelega, A., \& Wit, J. (1999). Validity of height velocity as a diagnostic criterion for idiopathic growth hormone deficiency and Turner syndrome. Hormone Research, 51(2), 68-73Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. The study proposes to share individual participant data that underlie the results reported in an article after deidentification (text, tables, figures, and appendices).
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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 Phase 1/2 study testing TruHeight Growth Protein Shake in people with Growth Disorders and Dietary Exposure, run by TruHeight Vitamins 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 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: finished, as of the sponsor's last update on 26 Mar 2024. 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.
What does this combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
Change in Height (time frame: 6 months). 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 26 Mar 2024.