Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old Children
NCT ID: NCT02725775
Last Updated: 2018-05-02
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
COMPLETED
NA
90 participants
INTERVENTIONAL
2016-03-31
2017-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Orange Juice Consumption and Cognitive Function
NCT01312610
The Effects of Orange Juice on Plasma Lipids
NCT01350843
Acute Effect of Orange Juice Mixed With Oat β-Glucan on Bioavailability of Polyphenols in Healthy Individuals
NCT04867655
Bioavailability and Bioactivity of Orange Polyphenols
NCT06430138
Beneficial Impact of Orange Juice Consumption on Risk Factors Associated With Cardiovascular Diseases
NCT02479568
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Following a practise session at screening (week -1) to familiarise the participants with the cognitive tests and study drinks, participants will take part in 3 test sessions - at baseline (Week 0), on Day 1 of intervention (start of Week 1; acute effects) and immediately post intervention (end of Week 10; chronic effects).
At week -1 (screening) children will be tested for colour blindness (Ishihara test) and complete the Wechsler abbreviated scale of intelligence (WASI) for screening purposes. Respiratory peak flow, height, and weight will also be measured to examine the relationship between cognitive performance and physical activity.
This study design, including both the test day and morning juice supplementation, is intended to emulate the children's normal routine as far as possible. Each carton of juice will be provided mid-morning to act as a supplement to their usual diet.
Measures:
The cognitive tests included in the study are listed below:
* Immediate and delayed picture recognition
* Delayed spatial memory
* Tower of Hanoi (executive function - planning/strategy)
* Corsi block tapping test (executive function and working memory)
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
BASIC_SCIENCE
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
100% OJ
240ml 100% Florida Orange Juice consumed on a daily basis for 10 weeks.
100% Florida OJ
Equicaloric Orange Drink
An equicaloric placebo orange drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour) consumed daily for 10 weeks.
Placebo Equicaloric Orange Drink
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
100% Florida OJ
Placebo Equicaloric Orange Drink
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* Willingness to consume test drinks during the study (determined by a score of 5 on the taste testing Likert scale for both orange juice drinks \[attached\])
* Ability to follow verbal and simple written instructions in English
* Ability to give written consent
* Normal vision, with appropriate corrective lenses if required
* Ability to understand cognitive testing instructions and responding requirements
Exclusion Criteria
* Colour blindness (to be assessed at screening using Tests for Colour Blindness (Isihara, 1951)
* Behavioural difficulties or attention disorders (e.g. Attention Deficit Hyperactivity Disorder)
* Learning disabilities which interfere with the ability to understand written or verbal communications
* Inability to understand the objective of the cognitive tests, or carry out the tests
* Any food allergies or intolerances to study drinks
* Acute illness, or feelings of unwell, within the week prior to testing
* Current administration of any psychotropic medication or supplementation in the month prior to testing, or during testing
* Hearing impairment that precludes the ability to follow verbal instructions
7 Years
10 Years
ALL
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Department of Citrus, State of Florida USA
UNKNOWN
University of East Anglia
OTHER
University of Leeds
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Prof Louise Dye
Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Clare Lawton, PhD
Role: PRINCIPAL_INVESTIGATOR
University of Leeds
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, United Kingdom
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
RFP 15-01
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.