A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.

Not Applicable

Active, not recruiting

• Conditions: Height and Weight; Cognitive Function

• Registration Number: NCT06704178
• Lead Sponsor: NuBest

Brief Summary

A 6-month virtual two-armed randomized double-blind placebo-controlled clinical trial. Participants will take NuBest Tall Growth Protein Powder or a placebo daily. Parents will complete questionnaires at baseline and monthly, and children will undergo cognitive assessments and height/weight measurements at specified intervals.

Detailed Description

Not available

Study Timeline

• Study Start: 2024-06-12
• Study First Submitted: 2024-08-07
• Status Verified: 2024-11
• Study First Submitted QC: 2024-11-22
• Last Update Submitted: 2024-11-22
• Study First Posted: 2024-11-26
• Last Update Posted: 2024-11-26
• Primary Completion: 2025-02-01
• Study Completion: 2025-02-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 60

Inclusion Criteria

• Interested in their child trialing a dietary supplement designed to improve overall health outcomes in children including height, maintenance of a healthy weight, cognitive function, immune function, and energy levels.
• Willing to refrain from giving their child any vitamins, minerals, or herbal supplements of any kind for the duration of the study.
• Parents willing to weigh and measure the height of their child throughout the study.
• Generally healthy - do not have any uncontrolled chronic disease.

Exclusion Criteria

• Any child with a history of endocrine disorder, heart disease, lung disease, kidney disease, digestive disease, or skeletal dysplasia.
• Any pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders.
• Is undergoing or planning to undergo significant medical procedures in the next six months.
• A history of severe allergic reactions, including but not limited to any of the product's ingredients.
• Any child with a dairy allergy or lactose intolerance.
• Has undergone any surgeries or invasive treatments in the last six months.
• Has had any major illness in the last three months.
• Having any planned invasive medical procedures during the study period.
• Currently participating in any other clinical study.
• Unwilling to follow the study protocol.
• Any child diagnosed with attention-deficit disorder (ADD) or attention-deficit hyperactivity disorder (ADHD).
• Any child currently taking or have taken in the last 3 months any prescription medication targeting ADD or ADHD (such as Adderall, Concerta, Focalin, Evekeo, or Ritalin).
• Any child that is a 'fussy' eater or who the parent suspects may not tolerate consuming the test product daily for six months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Improvement in Cognitive Function	Baseline and Month 6	The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test.

Secondary Outcome Measures

Name	Time	Method
Increase in Height	Baseline, Month 2, Month 4, and Month 6	Height measurement will be taken using an Ultrasonic Height Measuring Stadiometer. The increase in height will be tracked over the course of the study.
Maintenance of Healthy Weight	Baseline, Month 2, Month 4, and Month 6	Weight measurement will be taken using a FitBit Smart Scale. The maintenance of a healthy weight will be tracked over the course of the study.
Improvement in Energy Levels	Monthly from Baseline to Month 6	Energy levels will be assessed through parent-completed questionnaires evaluating the child's daily activity and perceived energy levels.
Improvement in Digestive Health	Monthly from Baseline to Month 6	Digestive health will be assessed through parent-completed questionnaires evaluating the child's digestive function, including frequency and quality of bowel movements.
Improvement in Immune Function	Monthly from Baseline to Month 6	Immune function will be assessed by tracking the number of illness episodes reported by parents over the 6-month study period.

Trial Locations

Locations (1)

Citruslabs; 🇺🇸 Santa Monica, California, United States