Clinical trial NCT06704178: A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
Official title: A Randomized Double-blind Placebo-controlled Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.
Study type: INTERVENTIONAL
Overall status: ACTIVE_NOT_RECRUITING
Phase: NA
Conditions: Height and Weight
Cognitive Function
Keywords: Dietary Supplement
Growth and Development
Lead sponsor: NuBest
Sponsor class: INDUSTRY
Collaborators: name: Citruslabs
First posted: 2024-11-26
Enrollment: 60
Sex: ALL
Minimum age (years): 10
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: A randomized, double-blind, placebo-controlled, two-arm trial.
Primary purpose: HEALTH_SERVICES_RESEARCH

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Improvement in Cognitive Function
timeFrame: Baseline and Month 6
Secondary outcomes:
measure: Increase in Height
timeFrame: Baseline, Month 2, Month 4, and Month 6
measure: Maintenance of Healthy Weight
timeFrame: Baseline, Month 2, Month 4, and Month 6
measure: Improvement in Energy Levels
timeFrame: Monthly from Baseline to Month 6
measure: Improvement in Digestive Health
timeFrame: Monthly from Baseline to Month 6
measure: Improvement in Immune Function
timeFrame: Monthly from Baseline to Month 6
Other outcomes:
Locations:
city: Santa Monica
country: United States
facility: Citruslabs
state: California
Study officials:
References: