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

NCT06329388 | Completed Phase 1 DMC

• 1 other identifier: CSD-SFRI-013
• Study Type: interventional
• Target: 32
• Locations: 1 country
• Sites: 1

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.

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

Outcome Measures

Primary Outcomes (1)

• 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.

  6 months

Secondary Outcomes (3)

• Change in Type X Collagen Concentration in Urine

  Baseline and 6 months

• Change in Body Composition

  Baseline, 3 months, and 6 months

• Incidence of Adverse Events

  Throughout the study period of 6 months

Study Arms (2)

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.

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.

Interventions

TruHeight Growth Protein Shake 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.

Treatment - Oral Protein Supplement

Eligibility Criteria

• Age: 4 Years - 17 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• Known allergies to ingredients in the protein shake
• Currently receiving growth hormone therapy
• Any medical condition that can affect growth or requires special diet

Sponsors & Collaborators

• TruHeight Vitamins: lead
• San Francisco Research Institute: collaborator

Study Sites (1)

SF Research Institute

San Francisco, California, 94127, United States

Location

Related Links

• Wikipedia contributors. (2023). Stadiometer. In Wikipedia
• Innovative Research. (n.d.). Human Collagen Type X ELISA Kit
• Gudmann, N., \& Karsdal, M. (2016). Type X Collagen. In Elsevier eBooks (pp. 73-76)
• 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), 1340-1344
• 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), 833-837
• 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), 68-73
• Linsenmayer, T. F., Eavey, R. D., \& Schmid, T. M. (1988). Type X collagen: A hypertrophic cartilage-specific molecule. Pathology and Immunopathology Research, 7(1), 14-19

MeSH Terms

Conditions

Growth Disorders; Body Weight; Child Nutrition Disorders

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Nutrition Disorders; Nutritional and Metabolic Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

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

Study Record Dates

• First Submitted: March 18, 2024
• First Posted: March 25, 2024
• Study Start: January 18, 2023
• Primary Completion: July 7, 2023
• Study Completion: August 11, 2023
• Last Updated: March 26, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, ANALYTIC CODE
• Time Frame: Starting at 6 months and ending 5 years following article publication.
• Access Criteria: Researchers who provide a methodologically sound proposal for use of the data in a peer-reviewed publication may access the data.

Locations

US (1)