Orange Juice Consumption and Cognitive Function

Nerve Degeneration Clinical Trial

— OJOC  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01312610
• Other study ID #: UReading_2010_OJOC
• Status: Completed
• Phase: N/A
• First received: March 9, 2011
• Last updated: November 22, 2011
• Start date: September 2010
• Est. completion date: September 2011

Study information

• Verified date: November 2011
• Source: University of Reading
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 2011
• Est. primary completion date: August 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 75 Years

Eligibility

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 Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Nerve Degeneration

Intervention

Dietary Supplement:
• High flavanone orange juice
High flavonone orange juice drink.
• Control orange juice
Orange beverage, low flavanone content, matched for total carbohydrate content, individual sugar profile, vitamin C

Locations

Country	Name	City	State
United Kingdom	University of Reading	Reading	Berkshire

Sponsors (1)

Lead Sponsor	Collaborator
University of Reading

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	Plasma flavanones	By High performance liquid chromatography	change from baseline to 8 weeks	No
Secondary	Blood pressure	Blood pressure measurement	change from baseline to 8 weeks	No