Clinical trial NCT06329388: Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
Official title: A Six-Month Randomized Controlled Pilot Study Evaluating the Effects of an Oral Protein Supplement on Children's Growth Patterns
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
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
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
Lead sponsor: TruHeight Vitamins
Sponsor class: INDUSTRY
Collaborators: name: San Francisco Research Institute
First posted: 2024-03-25
Enrollment: 32
Sex: ALL
Minimum age (years): 4
Maximum age (years): 17
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Randomized Controlled Trial (RCT) with two parallel groups (treatment and control group).
Primary purpose: TREATMENT

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:

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.

Eligibility criteria: 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

Primary outcomes:
measure: Change in Height
timeFrame: 6 months
Secondary outcomes:
measure: Change in Type X Collagen Concentration in Urine
timeFrame: Baseline and 6 months
measure: Change in Body Composition
timeFrame: Baseline, 3 months, and 6 months
measure: Incidence of Adverse Events
timeFrame: Throughout the study period of 6 months
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: SF Research Institute
state: California
Study officials:
References: