A Study to Evaluate the Effects of a Dietary Supplement on Children's Health and Development Outcomes.

NCT ID: NCT06704178

Last Updated: 2025-07-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 60 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-06-12
• Study Completion Date: 2025-02-16

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.

Conditions

Height; Cognitive Function; Weight Gain

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: HEALTH_SERVICES_RESEARCH
• Blinding Strategy: QUADRUPLE

Study Groups

Intervention Arm

Participants in this arm will take NuBest Tall Growth Protein Powder daily for 6 months.

Group Type: EXPERIMENTAL

NuBest Tall Growth Protein Powder

Intervention Type: DIETARY_SUPPLEMENT

NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes.

Placebo Arm

Participants in this arm will take a placebo product daily for 6 months.

Group Type: PLACEBO_COMPARATOR

Placebo Powder

Intervention Type: DIETARY_SUPPLEMENT

The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients.

Interventions

NuBest Tall Growth Protein Powder

NuBest Tall Growth Protein Powder includes a proprietary blend of vitamins, minerals, and probiotics designed to enhance children's health outcomes.

Intervention Type: DIETARY_SUPPLEMENT

Placebo Powder

The placebo powder is designed to mimic the appearance and taste of the NuBest Tall Growth Protein Powder but does not contain the active ingredients.

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 10 Years
• Maximum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Citruslabs

INDUSTRY

Sponsor Role: collaborator

NuBest

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Citruslabs

Santa Monica, California, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Document Type: Informed Consent Form

View Document

Other Identifiers

20424

Identifier Type: -

Identifier Source: org_study_id