A Six-Month Randomized Controlled Pilot Study Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
Trial Snapshot
- Phase
- Phase 1
- Status
- Completed
- Sponsor
- Enrollment
- 32
- Locations
- 1
- Primary Endpoint
- Change in Height
Study Overview
Brief 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.
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:
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- None
Eligibility Criteria
- Ages
- 4 Years to 17 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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
Exclusion Criteria
- •Known allergies to ingredients in the protein shake
- •Currently receiving growth hormone therapy
- •Any medical condition that can affect growth or requires special diet
Arms & Interventions
Treatment - Oral Protein Supplement
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.
Intervention: TruHeight Growth Protein Shake (Dietary Supplement)
Control - No Supplement
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.
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Change in Type X Collagen Concentration in Urine(Baseline and 6 months)
- Incidence of Adverse Events(Throughout the study period of 6 months)
- Change in Body Composition(Baseline, 3 months, and 6 months)