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
  Purpose

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.


Condition Intervention
Nerve Degeneration
Dietary Supplement: High flavanone orange juice
Dietary Supplement: Control orange juice

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Basic Science
Official Title: Effect of Chronic Orange Juice Consumption on Cognitive Function in Healthy Older Adults

Resource links provided by NLM:


Further study details as provided by University of Reading:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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


Enrollment: 40
Study Start Date: September 2010
Study Completion Date: September 2011
Primary Completion Date: August 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: High flavonone orange juice drink Dietary Supplement: High flavanone orange juice
High flavonone orange juice drink.
Other Name: 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

  Eligibility

Ages Eligible for Study:   60 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01312610

Locations
United Kingdom
University of Reading
Reading, Berkshire, United Kingdom, RG6 6AH.
Sponsors and Collaborators
University of Reading
Investigators
Principal Investigator: Jeremy PE Spencer, PhD University of Reading
Principal Investigator: Laurie T. Butler, PhD University of Reading
  More Information

No publications provided

Responsible Party: Jeremy Paul Edward Spencer, Professor Jeremy Spencer, University of Reading
ClinicalTrials.gov Identifier: NCT01312610     History of Changes
Other Study ID Numbers: UReading_2010_OJOC
Study First Received: March 9, 2011
Last Updated: November 22, 2011
Health Authority: United Kingdom: Research Ethics Committee

Keywords provided by University of Reading:
orange juice
cognitive function
flavonoids
flavanones

Additional relevant MeSH terms:
Nerve Degeneration
Pathologic Processes

ClinicalTrials.gov processed this record on August 21, 2014