Clinical trial NCT05581108: Enhancement of Learning and Memory Following Supplementation With Juice PLUS+® OMEGA in an Adolescent Population
Official title: Enhancement of Learning and Memory Following Supplementation With Juice PLUS+® OMEGA in an Adolescent Population
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Cognitive Change
Development, Adolescent
Keywords: Learning
Memory
Lead sponsor: University of Reading
Sponsor class: OTHER
Collaborators: name: Juice PLUS
First posted: 2022-10-14
Enrollment: 66
Sex: ALL
Minimum age (years): 13
Maximum age (years): 14
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: This study aims to investigate the effect of chronic supplementation with a commercially available, plant-derived, omega-3 intervention and cognitive performance in adolescent participants aged 13-14 years.

Detailed description: A healthy diet is an essential factor for healthy ageing. Previous studies of omega-3 polyunsaturated fatty acids (n-3 PUFAs) intake have shown beneficial actions on a range of human health conditions. The influence of n-3 PUFAs on cognition throughout the lifespan is particularly apparent, with beneficial effects documented on cognitive development in infants and children, cognitive performance in young adults, and to slow age-related cognitive impairment in older adults. Despite these positive findings, there has been little consideration of the influence of n-3-PUFAs on cognition in adolescence. Adolescence is characterized by profound brain development, with brain areas such as the prefrontal cortex continuing to mature into the late twenties). In this period of brain development, the basis is laid for executive functions (e.g., shifting, updating, and short-term memory), among others. Optimal development of the prefrontal cortex is very important, as the executive functions have been related to academic achievements. The positive effects from n-3 PUFAs on cognition, if translated to adolescents, would be of clear practical and theoretical importance, particularly in an academic context.

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This project will examine the relationship between supplementation with a commercially available, plant-derived, omega-3 intervention and cognitive performance in adolescent participants aged 13-14 years. In a randomized, placebo-controlled, double-blind, parallel-group clinical trial, we will examine the effect of 16 weeks repeated daily dosing of Juice PLUS+® OMEGA (or matched placebo) on a wide range of cognitive processes (measured using a battery of computer-based cognitive tests). Changes in cognitive performance will be mapped both to changes in omega-3 index (O3I) of our participants (measured using dried blood spots obtained via finger prick) and to changes in brain activity (measured using electrodes placed on the scalp, in a subset of participants). Participants will attend the Department on 3 separate occasions. At an initial screening visit, participants will practice the cognitive tests and provide a 3-day food diary as a measure of habitual diet. Participants will then attend a baseline test visit, where they will perform the cognitive tests and receive a 16-week supply of capsules (either placebo or active treatment) to be taken daily. After the 16 weeks, the participants will attend a post-intervention test day where they will perform the cognitive tests for a final time. Finger prick blood spot samples will be taken at each of the 3 visits.

Eligibility criteria: Inclusion Criteria:

* age 13-14, fruit and vegetable intake less than or equal to 3 servings per day, not more than 2 servings of fish per week, English as a first language, adequate visual and auditory acuity to perform the cognitive tasks, normal BMI for age, normal British Ability Scales (BAS) score

Exclusion Criteria:

* psychological or psychiatric disorders, ADHD or dyslexia diagnosis, fruit/vegetable or histamine intolerance, use of medications or dietary supplements that may impact study outcomes, conditions altering absorption of nutrients (e.g. celiac disease), antibiotic use within the last 3 months, adherence to any specific diets that may impact study outcomes (e.g. vegetarian, paleo etc.

Primary outcomes:
measure: Rate of Learning (Rey Auditory Verbal Learning Task)
timeFrame: Baseline
measure: Rate of Learning (Rey Auditory Verbal Learning Task)
timeFrame: 16 weeks
measure: Delayed Word Recall (Rey Auditory Verbal Learning Task)
timeFrame: Baseline
measure: Delayed Word Recall (Rey Auditory Verbal Learning Task)
timeFrame: 16 weeks
measure: Word Recognition (Rey Auditory Verbal Learning Task)
timeFrame: Baseline
measure: Word Recognition (Rey Auditory Verbal Learning Task)
timeFrame: 16 weeks
Secondary outcomes:
measure: Change in Modified Attention Network Task (MANT)
timeFrame: 16 weeks
measure: Change in N-Back
timeFrame: 16 weeks
measure: Change in PANAS-c
timeFrame: 16 weeks
measure: Change in Task Switching Test (TST)
timeFrame: 16 weeks
measure: Change in Emotion Regulation Questionnaire for Children and Adults (ERQ-CA)
timeFrame: 16 weeks
Other outcomes:
measure: Change in P300
timeFrame: 16 weeks
measure: Change in Omega 3 Index
timeFrame: 16 weeks
measure: Change in Power Spectral Density (PSD)
timeFrame: 16 weeks
Locations:
city: Reading
country: United Kingdom
facility: School of Psychology and Clinical Languages, University of Reading
state: Berkshire
Study officials:
affiliation: University of Reading
name: Claire Williams, Prof
role: PRINCIPAL_INVESTIGATOR
References: