Orange Juice Consumption and Cognitive Function (OJOC)

November 22, 2011 updated by: Jeremy Paul Edward Spencer, University of Reading

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Kingdom
    • Berkshire
      • Reading, Berkshire, United Kingdom, RG6 6AH.
        • University of Reading

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

60 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: High flavonone orange juice drink
Dietary supplement: High flavanone orange juice
High flavonone orange juice drink.
Other Names:
  • Frozen Orange Juice; Department of Citrus, Florida, USA.
Placebo Comparator: Control orange juice drink
Juice drink matched for sugar content
Dietary supplement: Control orange juice
Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Reading

Investigators

  • Principal Investigator: Laurie T. Butler, PhD, University of Reading

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2010

Primary Completion (Actual)

August 1, 2011

Study Completion (Actual)

September 1, 2011

Study Registration Dates

First Submitted

March 9, 2011

First Submitted That Met QC Criteria

March 9, 2011

First Posted (Estimate)

March 10, 2011

Study Record Updates

Last Update Posted (Estimate)

November 23, 2011

Last Update Submitted That Met QC Criteria

November 22, 2011

Last Verified

November 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UReading_2010_OJOC

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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