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

NCT05581108 | Completed

• 1 other identifier: RDG-007
• Study Type: interventional
• Target: 66
• Locations: 1 country
• Sites: 1

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.

Conditions

Cognitive Change; Development, Adolescent

Keywords

Learning; Memory

Outcome Measures

Primary Outcomes (6)

• Rate of Learning (Rey Auditory Verbal Learning Task)

  Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy. This occurs 5 times for the same word list, and the rate of learning is determined through change in accuracy across the 5 recalls.

  Baseline

• Rate of Learning (Rey Auditory Verbal Learning Task)

  Participants will be presented with a sequential list of 15 words, at a rate of 1 word per second. The participant will then have 60s to say out loud as many of these words as possible, with the resulting score recorded as a percentage of accuracy. This occurs 5 times for the same word list, and the rate of learning is determined through change in accuracy across the 5 recalls.

  16 weeks

• Delayed Word Recall (Rey Auditory Verbal Learning Task)

  After a period of time subject are asked to recall as many words as possible from list A

  Baseline

• Delayed Word Recall (Rey Auditory Verbal Learning Task)

  After a period of time subject are asked to recall as many words as possible from list A

  16 weeks

• Word Recognition (Rey Auditory Verbal Learning Task)

  Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.

  Baseline

• Word Recognition (Rey Auditory Verbal Learning Task)

  Following the delayed word recall, words from list A, list B and novel words are displayed sequentially on the screen and participants are asked to indicate which words were from list A only.

  16 weeks

Secondary Outcomes (5)

• Change in Modified Attention Network Task (MANT)

  16 weeks

• Change in N-Back

  16 weeks

• Change in PANAS-c

  16 weeks

• Change in Task Switching Test (TST)

  16 weeks

• Change in Emotion Regulation Questionnaire for Children and Adults (ERQ-CA)

  16 weeks

Other Outcomes (3)

• Change in P300

  16 weeks

• Change in Omega 3 Index

  16 weeks

• Change in Power Spectral Density (PSD)

  16 weeks

Study Arms (2)

Juice PLUS+® OMEGA

EXPERIMENTAL

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.

Dietary Supplement: Juice PLUS+® OMEGA

Matched placebo

PLACEBO COMPARATOR

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

Dietary Supplement: Placebo

Interventions

Juice PLUS+® OMEGA DIETARY_SUPPLEMENT

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

Juice PLUS+® OMEGA

Placebo DIETARY_SUPPLEMENT

matched placebo (2 capsules)

Matched placebo

Eligibility Criteria

• Age: 13 Years - 14 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Reading: lead
• Juice PLUS: collaborator

Study Sites (1)

School of Psychology and Clinical Languages, University of Reading

Reading, Berkshire, RG6 6AL, United Kingdom

Location

Study Officials

• Claire Williams, Prof

  University of Reading

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: June 13, 2022
• First Posted: October 14, 2022
• Study Start: October 4, 2021
• Primary Completion: July 21, 2023
• Study Completion: July 21, 2023
• Last Updated: October 16, 2023

Record last verified: 2023-10

Locations

GB (1)