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

NuBest

Status: Completed

Conditions: Cognitive Function; Weight Gain; Height

Treatments: Dietary Supplement: NuBest Tall Growth Protein Powder; Dietary Supplement: Placebo Powder

Study type: Interventional

Funder types: Industry

Identifiers

NCT06704178

20424

Details and patient eligibility

About

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.

Enrollment: 60 patients

Sex: All

Ages: 10 to 16 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Health Services Research

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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60 participants in 2 patient groups, including a placebo group

Intervention Arm

Experimental group

Description:

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

Treatment:

Dietary Supplement: NuBest Tall Growth Protein Powder

Placebo Arm

Placebo Comparator group

Description:

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

Treatment:

Dietary Supplement: Placebo Powder