Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1/PHASE2

Total Enrollment

32 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-01-18

Study Completion Date

2023-08-11

Brief Summary

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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.

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Detailed Description

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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

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Growth Disorders Dietary Exposure Child Development Bone Development Abnormal Body Weight Child Malnutrition

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group).

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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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.

Group Type EXPERIMENTAL

TruHeight Growth Protein Shake

Intervention Type DIETARY_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.

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.

Group Type NO_INTERVENTION

No interventions assigned to this group

Interventions

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TruHeight Growth Protein Shake

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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

Minimum Eligible Age

4 Years

Maximum Eligible Age

17 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes