Enhancement of Learning and Memory Following Supplementation With Juice PLUS+® OMEGA in an Adolescent Population

NCT ID: NCT05581108

Last Updated: 2023-10-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 66 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-10-04
• Study Completion Date: 2023-07-21

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.



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.

Conditions

Cognitive Change; Development, Adolescent

Study Design

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

Study Groups

Juice PLUS+® OMEGA

The Juice Plus+®Omega Blend capsules contain the following ingredients: DHA and EPAenriched oil of the micro algae Schizochytrium sp., pomegranate seed oil, coating agent: pullulan; raspberry seed oil, sea buckthorn oil 9, release agent: silicon dioxide; high oleic safflower seed oil, tomato seed oil, orange oil, vanilla oil, antioxidant: rosemary extract.

Group Type: EXPERIMENTAL

Juice PLUS+® OMEGA

Intervention Type: DIETARY_SUPPLEMENT

Daily dose of total Omega blend: 925 mg (2 capsules)

Matched placebo

Placebo capsules consist of medium chain triglycerides oil+ excipients like silicon dioxide aerosil, lecithin, vanilla flavor, orange oil, water and hypromellose(shell).

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: DIETARY_SUPPLEMENT

matched placebo (2 capsules)

Interventions

Juice PLUS+® OMEGA

Daily dose of total Omega blend: 925 mg (2 capsules)

Intervention Type: DIETARY_SUPPLEMENT

Placebo

matched placebo (2 capsules)

Intervention Type: DIETARY_SUPPLEMENT

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.

• Minimum Eligible Age: 13 Years
• Maximum Eligible Age: 14 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Juice PLUS

UNKNOWN

Sponsor Role: collaborator

University of Reading

OTHER

Sponsor Role: lead

Responsible Party

Prof Claire Williams

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Claire Williams, Prof

Role: PRINCIPAL_INVESTIGATOR

University of Reading

Locations

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, United Kingdom

Countries

United Kingdom

Provided Documents

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

RDG-007

Identifier Type: -

Identifier Source: org_study_id