HealthyNCT02725775
Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old Children
A study testing 100% Florida OJ in people with Healthy, run by University of Leeds at 1 site in United Kingdom.
Trial summary
This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. Read more about this study
- Who is it for?
- Ages 7 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy
- What is being tested?
- 100% Florida OJ
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 90 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Mar 2016to May 2017
- 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 7 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Male or female, aged 7-10 years
- 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
Who cannot join
- Poor general health
- 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
Show all 9Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
Human Appetite Research Unit, University of Leeds
Leeds, West Yorkshire, LS29JT
About this study
Official title: A Study of the Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old UK School Children
This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an improvement in performance at week 10).
Read the detailed description
This study will employ a randomised 10 week, parallel groups, double blind, placebo controlled design to investigate the effects of daily supplemental orange juice compared with an equicaloric placebo orange drink on cognitive performance in 7-10 year old school children. Following screening, participants will be randomly assigned to one of two conditions: (1) Active group: 100% orange juice, (2) Placebo group: control drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour). Both the active and control groups will receive a drink daily for 10 weeks delivered as a school-based morning intervention administered by researchers. Children will also be given drinks to consume over the weekends and school holidays monitored by a drink intake diary. Participants, parents and teachers will be blind to their assigned condition. Researchers will also be blinded until completion of the data analysis.
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
- Healthy
- Being tested
- 100% Florida OJ, Placebo Equicaloric Orange Drink
- Keywords
- Orange Juice, Polyphenol, Cognition
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
100% Florida OJDietary supplement
Placebo Equicaloric Orange DrinkDietary supplement
| Study group | Role | What they receive |
|---|---|---|
| 100% OJ | Active comparator | 240ml 100% Florida Orange Juice consumed on a daily basis for 10 weeks. Receives: Dietary Supplement: 100% Florida OJ |
| Equicaloric Orange Drink | Placebo comparator | An equicaloric placebo orange drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour) consumed daily for 10 weeks. Receives: Dietary Supplement: Placebo Equicaloric Orange Drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
Immediate and delayed picture recognition
Primary dependent variable: number of pictures successfully recalled (from 20 presented) immediately following presentation and after a delay consisting of two cognitive tests (Corsi Tapping and Tower of Hanoi).
Measured: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Secondary outcomes (3)
Delayed spatial memory
Primary dependent variable: number of spatial patterns successfully recognised from initial presentation (14 patterns presented twice). Recognition memory paradigm showing participants two patterns; one which was shown in the presentation phase and one which was not and requesting the participant select the presented pattern. Between presentation and recognition phases the participants engaged in a Corsi tapping test and a Tower of Hanoi test.
Measured: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Tower of Hanoi (executive function)
Executive function - planning/strategy. Primary dependent variables: number of correctly solved puzzles and number of errors. Participants complete 2 trials at 8 levels of difficulty (difficulty indexed by number of moves required to complete the puzzle).
Measured: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Corsi block tapping test (Executive function and working memory)
Executive function and working memory. Primary dependent variables: number of correctly recalled "block" presentations. An array of 9 white boxes are presented. Individual boxes are illuminated in sequences of increasing number of target presentations (2 - 8 boxes illuminated). After each pattern sequence is completed, participants are presented with the blank array of white boxes and are required to repeat the pattern in sequential order.
Measured: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Apr 2016 (estimated)
- Study startMar 2016
- Primary completionMar 2017
- Study completionMay 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HealthyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Leeds
- Sponsor type
- University, hospital or other
- Collaborators
- Department of Citrus, State of Florida USA, University of East Anglia
- Responsible party
- Principal investigator, Prof Louise Dye, University of Leeds
- Investigators
- Clare Lawton, PhD, Principal investigator, University of Leeds
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02725775
- Sponsor's protocol ID
- RFP 15-01
- Status last verified
- Apr 2018
- First submitted
- 22 Mar 2016
- Last updated
- 2 May 2018
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 May 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Study of the Acute and Chronic Effects of 100% Florida Orange Juice Consumption on Cognitive Performance in 7-10 Year Old UK School Children
- ClinicalTrials.gov ID
- NCT02725775
- Acronym / sponsor ID
- RFP 15-01
- Conditions
- Healthy
- Keywords
- Orange Juice, Polyphenol, Cognition
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 90 participants (actual)
- Lead sponsor
- University of LeedsUniversity, hospital or other
- Collaborators
- Department of Citrus, State of Florida USA, University of East Anglia
- Study start
- Mar 2016
- Primary completion
- Mar 2017 (actual)
- Study completion
- May 2017 (actual)
- First posted
- 1 Apr 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an improvement in performance at week 10).
Detailed description
This study will employ a randomised 10 week, parallel groups, double blind, placebo controlled design to investigate the effects of daily supplemental orange juice compared with an equicaloric placebo orange drink on cognitive performance in 7-10 year old school children. Following screening, participants will be randomly assigned to one of two conditions: (1) Active group: 100% orange juice, (2) Placebo group: control drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour). Both the active and control groups will receive a drink daily for 10 weeks delivered as a school-based morning intervention administered by researchers. Children will also be given drinks to consume over the weekends and school holidays monitored by a drink intake diary. Participants, parents and teachers will be blind to their assigned condition. Researchers will also be blinded until completion of the data analysis.
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)
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 100% OJ | Active comparator | Dietary Supplement: 100% Florida OJ240ml 100% Florida Orange Juice consumed on a daily basis for 10 weeks. |
| Equicaloric Orange Drink | Placebo comparator | Dietary Supplement: Placebo Equicaloric Orange DrinkAn equicaloric placebo orange drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour) consumed daily for 10 weeks. |
Who may qualify
- Ages
- 7 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (6 listed)
- Male or female, aged 7-10 years
- 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
Key exclusion criteria (9 listed)
- Poor general health
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 100% Florida OJ | Dietary supplement | 100% OJ |
| Placebo Equicaloric Orange Drink | Dietary supplement | Equicaloric Orange Drink |
Primary outcome
Immediate and delayed picture recognition
Time frame: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Primary dependent variable: number of pictures successfully recalled (from 20 presented) immediately following presentation and after a delay consisting of two cognitive tests (Corsi Tapping and Tower of Hanoi).
3 secondary outcomes
Delayed spatial memory
Time frame: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Tower of Hanoi (executive function)
Time frame: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Corsi block tapping test (Executive function and working memory)
Time frame: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 May 2018.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clare Lawton, PhD principal investigator
University of Leeds
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 100% Florida OJ in people with Healthy, run by University of Leeds 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 6 inclusion and 9 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 2 May 2018. 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?
Immediate and delayed picture recognition (time frame: Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 2 May 2018.