Orange Juice Consumption and Cognitive Function (OJOC)

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Jeremy Paul Edward Spencer, University of Reading
ClinicalTrials.gov Identifier:
NCT01312610
First received: March 9, 2011
Last updated: November 22, 2011
Last verified: November 2011

March 9, 2011
November 22, 2011
September 2010
August 2011   (final data collection date for primary outcome measure)
Executive function - Attention [ Time Frame: change in attention from baseline and 8 weeks ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01312610 on ClinicalTrials.gov Archive Site
  • Plasma flavanones [ Time Frame: change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    By High performance liquid chromatography
  • Blood pressure [ Time Frame: change from baseline to 8 weeks ] [ Designated as safety issue: No ]
    Blood pressure measurement
Same as current
Not Provided
Not Provided
 
Orange Juice Consumption and Cognitive Function
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Nerve Degeneration
  • Dietary Supplement: High flavanone orange juice
    High flavonone orange juice drink.
    Other Name: Frozen Orange Juice; Department of Citrus, Florida, USA.
  • Dietary Supplement: Control orange juice
    Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C
  • Experimental: High flavonone orange juice drink
    Intervention: Dietary Supplement: High flavanone orange juice
  • Placebo Comparator: Control orange juice drink
    Juice drink matched for sugar content
    Intervention: Dietary Supplement: Control orange juice
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
40
September 2011
August 2011   (final data collection date for primary outcome measure)

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
Both
60 Years to 75 Years
Yes
Contact information is only displayed when the study is recruiting subjects
United Kingdom
 
NCT01312610
UReading_2010_OJOC
Yes
Jeremy Paul Edward Spencer, University of Reading
University of Reading
Not Provided
Principal Investigator: Jeremy PE Spencer, PhD University of Reading
Principal Investigator: Laurie T. Butler, PhD University of Reading
University of Reading
November 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP