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Completed

NCT Number: NCT01312610

Orange Juice Consumption and Cognitive Function

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.

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Key information

Conditions

Nerve Degeneration Pathologic Processes Pathological Conditions, Signs and Symptoms

Age range

60 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University of Reading

Reading, Berkshire, RG6 6AH., United Kingdom

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

High flavanone orange juice

Dietary Supplement

High flavonone orange juice drink.

Other names: Frozen Orange Juice; Department of Citrus, Florida, USA.

Control orange juice

Dietary Supplement

Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C

Primary outcomes

  1. 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.

Secondary outcomes

  1. Plasma flavanones

    Time frame: change from baseline to 8 weeks

    By High performance liquid chromatography

  2. Blood pressure

    Time frame: change from baseline to 8 weeks

    Blood pressure measurement

Sponsors and collaborators

Lead sponsor

University of Reading

Other

Registry information

Official study title

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

Acronym: OJOC

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Mar 10, 2011
Registry last updated
Nov 23, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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