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Cognitive ChangeAdCog-ONCT05581108

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

A study testing Juice PLUS+® OMEGA in people with Cognitive Change and Development, Adolescent, run by University of Reading at 1 site in United Kingdom.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 13 to 14 yearsHealthy volunteers can take part
Conditions the study is for
Cognitive Change, Development, Adolescent
What is being tested?
Juice PLUS+® OMEGA
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
66 participants
Where
1 siteUnited Kingdom
Study dates
4 Oct 2021to 21 Jul 2023
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 13 to 14 years
  • All sexes
  • Healthy volunteers accepted
  • Child

Who may be able to join

  • 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

Who cannot join

  • 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.

Trial locations and contacts

1 site in 1 country.

United Kingdom1 site
  • School of Psychology and Clinical Languages, University of Reading

    Reading, Berkshire, RG6 6AL

Other trials in United Kingdom

About this study

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.

Read the 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.

Being tested
Juice PLUS+® OMEGA, Placebo
Keywords
Learning, Memory

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Juice PLUS+® OMEGADietary supplement

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

  • PlaceboDietary supplement

    matched placebo (2 capsules)

Study groups in NCT05581108
Study groupRoleWhat they receive
Juice PLUS+® OMEGAExperimentalThe 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.
Receives: Dietary Supplement: Juice PLUS+® OMEGA
Matched placeboPlacebo comparatorPlacebo capsules consist of medium chain triglycerides oil+ excipients like silicon dioxide aerosil, lecithin, vanilla flavor, orange oil, water and hypromellose(shell).
Receives: Dietary Supplement: Placebo

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. 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.

    Measured: Baseline

  2. 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.

    Measured: 16 weeks

  3. 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

    Measured: Baseline

  4. 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

    Measured: 16 weeks

  5. 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.

    Measured: Baseline

  6. 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.

    Measured: 16 weeks

Secondary outcomes (5)
  1. Change in Modified Attention Network Task (MANT)

    This task examines execution function, attention and inhibition. In this task, participants have to respond to a centrally presented arrow, pointing to the left or the right by pressing the corresponding key on the keyboard. The central arrow is flanked by arrows that point in the same (congruent) or opposite (incongruent) direction. In order to perform the task effectively, participants have to ignore the flanking arrows. Previous studies have found that participants show larger latencies and more errors on incongruent trials when compared with congruent trials due to the conflicting interference of the incongruently facing arrows. The response latencies to congruent trials reflect processing speed, while the amount of interference during incongruent trials indicates susceptibility to interference.

    Measured: 16 weeks

  2. Change in N-Back

    The N-Back task is a measure of working memory where participants are instructed to monitor a series of stimuli and to respond whenever a stimulus is presented that is the same as the one presented n trials previously. In this simplified 0-back version, participants respond when the target matches a fixed target specified at the beginning of the task (similar to a Go/No-Go task). Data will be analysed for both accuracy and reaction time on correct trials. For a subset of participants, this task will be conducted while recording EEG in order to monitor change in brain activity in response to target trials. The N-Back was selected as it has been shown in previous work to elicit a strong P300 signal (see EEG as additional outcome).

    Measured: 16 weeks

  3. Change in PANAS-c

    A validated self-report measure of affective state in children. The PANAS comprises of two distinct affective states (positive and negative), as well as 11 individual affective states (fear, guilt, sadness, surprise, hostility, shyness, joviality, self-assurance, attentiveness, fatigue and serenity. Subjects use a likert scale from 1 - 5 to indicate how the word relates to how they are currently feeling.

    Measured: 16 weeks

  4. Change in Task Switching Test (TST)

    This task requires executive function and sustained attention, and provides a measure of cognitive flexibility. Participants view a circle with 8 equally spaced radii 2 of which form a bold bisecting line. Numbers are chosen randomly from a set of 1-4 \& 6-9 and displayed sequentially in a clockwise direction. A response of higher or lower than 5 is made for trials below the bold line, and even or odd for numbers above the line. Outcome measures include overall accuracy and reaction time (RT) on correct trials, as well as accuracy and RT on trials where there is a 'switch cost' from stimuli moving from below to above the bold line and vice versa.

    Measured: 16 weeks

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

    A validated 10-item questionnaire used to assess emotion regulation, specifically reappraisal and suppression.

    Measured: 16 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2022
  2. Study start4 Oct 2021
  3. Primary completion21 Jul 2023
  4. Study completion21 Jul 2023

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Quadruple blind
Who is masked
Participant, Care provider, Investigator, Outcomes assessor
Enrolment
66 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05581108
Sponsor's protocol ID
RDG-007
Acronym
AdCog-O
Status last verified
Oct 2023
First submitted
13 Jun 2022
Last updated
16 Oct 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Bell L, Eastwood J, Lamprecht M, Williams CM. Investigating enhancement of learning and memory following supplementation with Juice Plus+(R) Omega in an adolescent population. Eur J Nutr. 2026 Jun 29;65(5):182. doi: 10.1007/s00394-026-04012-9.

    PubMed 42371128

Questions about this trial

What is this clinical trial studying?

A study testing Juice PLUS+® OMEGA in people with Cognitive Change and Development, Adolescent, run by University of Reading at 1 site in United Kingdom.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Oct 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Rate of Learning (Rey Auditory Verbal Learning Task) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05581108, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Oct 2023.

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