Ignite Creation Date:
2024-05-06 @ 8:17 PM
Last Modification Date:
2024-10-26 @ 3:24 PM
Study NCT ID:
NCT06329388
Status:
COMPLETED
Last Update Posted:
2024-03-26
First Post:
2024-03-18
Brief Title:
Evaluating the Effects of an Oral Protein Supplement on Childrens Growth Patterns
Sponsor:
TruHeight Vitamins
Organization:
TruHeight Vitamins
Study Overview
Official Title:
A Six-Month Randomized Controlled Pilot Study Evaluating the Effects of an Oral Protein Supplement on Childrens Growth Patterns
Status:
COMPLETED
Status Verified Date:
2024-03
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 treatmentsupplement 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 participants 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 treatmentsupplement 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
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 treatmentsupplement 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 participants 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 treatmentsupplement 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None