Clinical Trial Details
— Status: Completed
Administrative data
| NCT number |
NCT06329388 |
| Other study ID # |
CSD-SFRI-013 |
| Secondary ID |
|
| Status |
Completed |
| Phase |
Phase 1/Phase 2
|
| First received |
|
| Last updated |
|
| Start date |
January 18, 2023 |
| Est. completion date |
August 11, 2023 |
Study information
| Verified date |
March 2024 |
| Source |
TruHeight Vitamins |
| Contact |
n/a |
| Is FDA regulated |
No |
| Health authority |
|
| Study type |
Interventional
|
Clinical 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 concentration in urine, height via a
stadiometer, and body composition using an INBODY device.
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.
