Orange Juice Consumption and Cognitive Function

Study Overview
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Brief Summary
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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.

Official Title
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Effect of Chronic Orange Juice Consumption on Cognitive Function in Healthy Older Adults

Conditions
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Nerve Degeneration

Intervention / Treatment
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* Dietary Supplement: High flavanone orange juice
* Dietary Supplement: Control orange juice


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 60 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: High flavonone orange juice drink<br> | Dietary Supplement: High flavanone orange juice<br>* High flavonone orange juice drink.<br>* Other names: Frozen Orange Juice; Department of Citrus, Florida, USA.;|
| Placebo Comparator: Control orange juice drink<br>Juice drink matched for sugar content | Dietary Supplement: Control orange juice<br>* Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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. | change in attention from baseline and 8 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plasma flavanones | By High performance liquid chromatography | change from baseline to 8 weeks | 
| Blood pressure | Blood pressure measurement | change from baseline to 8 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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orange juice, cognitive function, flavonoids, flavanones