Nerve DegenerationOJOCNCT01312610
Orange Juice Consumption and Cognitive Function
A study testing High flavanone orange juice in people with Nerve Degeneration, run by University of Reading at 1 site in United Kingdom.
Trial summary
This study is investigating the effect of 8 weeks of orange juice supplementation on executive function in healthy older adults. The study is a controled, double-blind, crossover trial and involves a 8 week supplementation with a high flavonone orange juice and a carbohydrate-matched control. Read more about this study
- Who is it for?
- Ages 60 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Nerve Degeneration
- What is being tested?
- High flavanone orange juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- Sep 2010to Sep 2011
- 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 60 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- In good general health i.e. no major health condition such as diabetes
- BMI < 30
- Cholesterol < 6 and BP < 150/90
- Not on blood pressure medication or blood thinning medication such as aspirin - No learning difficulty such as dyslexia
Who cannot join
- Diabetes
- Gastro-intestinal disease
- High BMI
- Cholesterol and BP
- Smoker
- On blood pressure medication or blood thinning medication such as aspirin
- Dyslexic/dyspraxic
- Depression or history of depression
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site
University of Reading
Reading, Berkshire, RG6 6AH.
About this study
Official title: Effect of Chronic Orange Juice Consumption on Cognitive Function in Healthy Older Adults
This study is investigating the effect of 8 weeks of orange juice supplementation on executive function in healthy older adults. The study is a controled, double-blind, crossover trial and involves a 8 week supplementation with a high flavonone orange juice and a carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the control juice per day for an 8 week period. There is then an 8 week washout period before subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm at the beginning of the study. Measures of cognitive function will be administered pre and post both test and control interventions. Blood pressure will also be measured and blood and urine samples will be collected to assess absorption of from the juice. A sub-sample of volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow information.
- Conditions
- Nerve Degeneration
- Being tested
- High flavanone orange juice, Control orange juice
- Keywords
- orange juice, cognitive function, flavonoids, flavanones
- Medical subject headings
- Nerve Degeneration
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
High flavanone orange juiceDietary supplement
Also called Frozen Orange Juice; Department of Citrus, Florida, USA.
High flavonone orange juice drink.
Control orange juiceDietary supplement
Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C
| Study group | Role | What they receive |
|---|---|---|
| High flavonone orange juice drink | Experimental | Not described Receives: Dietary Supplement: High flavanone orange juice |
| Control orange juice drink | Placebo comparator | Juice drink matched for sugar content Receives: Dietary Supplement: Control orange juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Executive function - Attention
Assessment by human cognitive test battery delivered by computer and human operator. Assessments will be carried out at baseline and at the end of each intervention arm.
Measured: change in attention from baseline and 8 weeks
Secondary outcomes (2)
Plasma flavanones
By High performance liquid chromatography
Measured: change from baseline to 8 weeks
Blood pressure
Blood pressure measurement
Measured: change from baseline to 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Mar 2011 (estimated)
- Study startSep 2010
- Primary completionAug 2011
- Study completionSep 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Nerve DegenerationStudies 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
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Reading
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jeremy Paul Edward Spencer, University of Reading
- Investigators
- Jeremy PE Spencer, PhD, Principal investigator, University of ReadingLaurie T. Butler, PhD, Principal investigator, University of Reading
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01312610
- Sponsor's protocol ID
- UReading_2010_OJOC
- Acronym
- OJOC
- Status last verified
- Nov 2011
- First submitted
- 9 Mar 2011
- Last updated
- 23 Nov 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14.
PubMed 25733635
Study at a glance
From the registry record, last updated by the sponsor on 23 Nov 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Chronic Orange Juice Consumption on Cognitive Function in Healthy Older Adults
- ClinicalTrials.gov ID
- NCT01312610
- Acronym / sponsor ID
- OJOC / UReading_2010_OJOC
- Conditions
- Nerve Degeneration
- Keywords
- orange juice, cognitive function, flavonoids, flavanones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- University of ReadingUniversity, hospital or other
- Study start
- Sep 2010
- Primary completion
- Aug 2011 (actual)
- Study completion
- Sep 2011 (actual)
- First posted
- 10 Mar 2011 (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 investigating the effect of 8 weeks of orange juice supplementation on executive function in healthy older adults. The study is a controled, double-blind, crossover trial and involves a 8 week supplementation with a high flavonone orange juice and a carbohydrate-matched control. Volunteers consume 500ml of either the test juice or the control juice per day for an 8 week period. There is then an 8 week washout period before subjects proceed to the other arm of the study. Subjects are randomly assigned to either arm at the beginning of the study. Measures of cognitive function will be administered pre and post both test and control interventions. Blood pressure will also be measured and blood and urine samples will be collected to assess absorption of from the juice. A sub-sample of volunteers will undergo MRI imaging pre- and post intervention to acquire cerebral blow flow information.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| High flavonone orange juice drink | Experimental | Dietary Supplement: High flavanone orange juice |
| Control orange juice drink | Placebo comparator | Dietary Supplement: Control orange juiceJuice drink matched for sugar content |
Who may qualify
- Ages
- 60 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- In good general health i.e. no major health condition such as diabetes
- BMI < 30
- Cholesterol < 6 and BP < 150/90
- Not on blood pressure medication or blood thinning medication such as aspirin - No learning difficulty such as dyslexia
Key exclusion criteria (8 listed)
- Diabetes
- Gastro-intestinal disease
- High BMI
- Cholesterol and BP
- Smoker
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 |
|---|---|---|
| High flavanone orange juiceAlso: Frozen Orange Juice; Department of Citrus, Florida, USA.High flavonone orange juice drink. | Dietary supplement | High flavonone orange juice drink |
| Control orange juiceOrange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C | Dietary supplement | Control orange juice drink |
Primary outcome
Executive function - Attention
Time frame: change in attention from baseline and 8 weeks
Assessment by human cognitive test battery delivered by computer and human operator. Assessments will be carried out at baseline and at the end of each intervention arm.
2 secondary outcomes
Plasma flavanones
Time frame: change from baseline to 8 weeks
Blood pressure
Time frame: change from baseline to 8 weeks
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 23 Nov 2011.
- Derived from this study: PubMed 25733635Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14.
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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.
Jeremy PE Spencer, PhD principal investigator
University of Reading
Laurie T. Butler, PhD principal investigator
University of Reading
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing High flavanone orange juice in people with Nerve Degeneration, 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 4 inclusion and 8 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 23 Nov 2011. 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?
Executive function - Attention (time frame: change in attention from baseline and 8 weeks). 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 NCT01312610, 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 23 Nov 2011; AzTrials last refreshed its copy on 2 Nov 2026.