The goal of this clinical trial is to evaluate the efficacy of Kids Plus Multi \& Omega dietary supplement on cognitive function in children after 49 days of supplementation. The main question it aims to answer is: Is there a difference in change in individual cognitive domains between Kids Plus Multi \& Omega and placebo? Participants will be asked to consume Kids Plus Multi \& Omega or placebo and complete various cognitive assessment tests throughout the duration of the study.
The investigational product, Kids Plus Multi \& Omega dietary supplement contains a mixture of vitamins, minerals, and omega-3 fatty acids. Emerging evidence reports the positive effects of micronutrient supplementation on cognitive performance among school-aged children. However, there is still limited evidence on the efficacy of multiple micronutrient supplementation on other aspects of cognitive function in children. Therefore, the objective of this randomized, triple-blind placebo-controlled clinical trial is to evaluate the efficacy of Kids Plus Multi \& Omega dietary supplement on cognitive function in children after 49 days of supplementation. Overall cognitive function as well as cognitive domains related to focus, memory, learning and cognitive flexibility will be assessed using the National Institutes of Health (NIH) Toolbox Cognition Battery.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
120
Participants will be instructed to take two gummies of Kids Plus Multi and Omegas with or without food once daily for the duration of the study starting on Day 1 with a recommendation to consume in the morning for consistency.
Participants will be instructed to take two gummies of placebo with or without food once daily for the duration of the study starting on Day 1 with a recommendation to consume in the morning for consistency.
KGK Science Inc.
London, Ontario, Canada
The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo
The difference in change in individual cognitive domains as assessed by the NIH Toolbox Cognition tests from baseline at Day 28 between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 28
The difference in change in individual cognitive domains between Kids Plus Multi and Omega and placebo
The difference in change in individual cognitive domains as assessed by the NIH Toolbox Cognition tests from baseline at Day 49 between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 49
The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) between Kids Plus Multi and Omega and placebo
The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) as assessed by the NIH Toolbox Cognition tests from baseline at Day 28 between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 28
The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) between Kids Plus Multi and Omega and placebo
The difference in change in Total Cognition Composite score (for children aged 7+ years) or Early Childhood Composite score (for children aged 4-6 years) as assessed by the NIH Toolbox Cognition tests from baseline at Day 49 between Kids Plus Multi and Omega and placebo
Time frame: Day 0 (baseline) to 49
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
The difference in change in quality of life as assessed by the KINDL-R questionnaire between Kids Plus Multi and Omega and placebo from baseline at Day 28.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Day 0 (baseline) to 28
The difference in change in quality of life between Kids Plus Multi and Omega and placebo
The difference in change in quality of life as assessed by the KINDL-R questionnaire between Kids Plus Multi and Omega and placebo from baseline at Day 49
Time frame: Day 0 (baseline) to 49
The difference in change in stress between Kids Plus Multi and Omega and placebo
The difference in change in stress as assessed by Perceived Stress Scale for Children (PSS-C) between Kids Plus Multi and Omega and placebo from baseline at Day 28. The PSS-C has a scale range from 0-39 with higher scores indicating higher stress levels.
Time frame: Day 0 (baseline) to 28
The difference in change in stress between Kids Plus Multi and Omega and placebo
The difference in change in stress as assessed by Perceived Stress Scale for Children (PSS-C) between Kids Plus Multi and Omega and placebo from baseline at Day 49. The PSS-C has a scale range from 0-39 with higher scores indicating higher stress levels.
Time frame: Day 0 (baseline) to 49