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

NCT06704178 | Completed Results

• 1 other identifier: 20424
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

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

Keywords

Dietary Supplement; Growth and Development

Outcome Measures

Primary Outcomes (5)

• Change Mean Percentile Score in Double Trouble

  The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

  Baseline and Month 6

• IChange Mean Percentile Score in Feature Match

  The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Feature Match is a focus and processing task. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

  Baseline and Month 6

• Change Mean Percentile Score in Grammatical Reasoning

  The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Grammatical Reasoning is a deductive reasoning task that requires quickly interpreting phrases and making logical conclusions from understanding. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

  Baseline to Month 6

• Change Mean Percentile Score in Digit Span

  The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Digit Span requires users to focus on displayed numbers, hold them in short-term memory, and repeat them back correctly. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

  Baseline to Month 6

• Change Mean Percentile Score in Token Search

  The primary outcome measure will assess the improvement in cognitive function as evaluated by a cognitive test. Leveraging the brain's executive functioning skills, Token Search requires participants to hold information in working memory and remain focused on completing sequential steps. Participants received a percentile score (1-100) on the assessment, with a higher score indicating a better response.

  Baseline to Month 6

Secondary Outcomes (67)

• Increase in Height

  Baseline, Month 2, Month 4, and Month 6

• Changes in Weight

  Baseline, Month 2, Month 4, and Month 6

• Changes in Overall Health as Reported by Parents

  Monthly from Baseline to Month 6

• Change in Parents' Perception of the Child's Health in the Future.

  Monthly from Baseline to Month 6

• Parents' Perception of the Change in Child's Health Compared to One Month Ago.

  Monthly from Baseline to Month 6

Study Arms (2)

Intervention Arm

EXPERIMENTAL

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

Dietary Supplement: NuBest Tall Growth Protein Powder

Placebo Arm

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo Powder

Interventions

NuBest Tall Growth Protein Powder DIETARY_SUPPLEMENT

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

Intervention Arm

Placebo Powder 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.

Placebo Arm

Eligibility Criteria

• Age: 10 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• NuBest: lead
• Citruslabs: collaborator

Study Sites (1)

Citruslabs

Santa Monica, California, 90404, United States

Location

MeSH Terms

Conditions

Weight Gain

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Results Point of Contact

• Title: Patrick Renner
• Organization: Citruslabs

hello@citruslabs.com

+1 805-876-4484

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: The study is double-blind; participants, care providers, investigators, and outcomes assessors are all masked to the allocation of intervention or placebo.
• Purpose: HEALTH SERVICES RESEARCH
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: A randomized, double-blind, placebo-controlled, two-arm trial.

Study Record Dates

• First Submitted: August 7, 2024
• First Posted: November 26, 2024
• Study Start: June 12, 2024
• Primary Completion: February 16, 2025
• Study Completion: February 16, 2025
• Last Updated: July 24, 2025
• Results First Posted: July 24, 2025

Record last verified: 2025-07

Locations

US (1)