NCT01312610

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Sep 2010

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

March 10, 2011

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2011

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2011

Completed
Last Updated

November 23, 2011

Status Verified

November 1, 2011

Enrollment Period

11 months

First QC Date

March 9, 2011

Last Update Submit

November 22, 2011

Conditions

Nerve Degeneration

Keywords

orange juicecognitive functionflavonoidsflavanones

Outcome Measures

Primary Outcomes (1)

  • 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

Secondary Outcomes (2)

  • Plasma flavanones

    change from baseline to 8 weeks

  • Blood pressure

    change from baseline to 8 weeks

Study Arms (2)

High flavonone orange juice drink

EXPERIMENTAL
Dietary Supplement: High flavanone orange juice

Control orange juice drink

PLACEBO COMPARATOR

Juice drink matched for sugar content

Dietary Supplement: Control orange juice

Interventions

High flavanone orange juiceDIETARY_SUPPLEMENT

High flavonone orange juice drink.

Also known as: Frozen Orange Juice; Department of Citrus, Florida, USA.
High flavonone orange juice drink
Control orange juiceDIETARY_SUPPLEMENT

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

Control orange juice drink

Eligibility Criteria

Age60 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Reading

Reading, Berkshire, RG6 6AH., United Kingdom

Location

Related Publications (1)

  • Kean RJ, Lamport DJ, Dodd GF, Freeman JE, Williams CM, Ellis JA, Butler LT, Spencer JP. Chronic consumption of flavanone-rich orange juice is associated with cognitive benefits: an 8-wk, randomized, double-blind, placebo-controlled trial in healthy older adults. Am J Clin Nutr. 2015 Mar;101(3):506-14. doi: 10.3945/ajcn.114.088518. Epub 2015 Jan 14.

    PMID: 25733635DERIVED

MeSH Terms

Conditions

Nerve Degeneration

Condition Hierarchy (Ancestors)

Pathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • Jeremy PE Spencer, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

  • Laurie T. Butler, PhD

    University of Reading

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor Jeremy Spencer

Study Record Dates

First Submitted

March 9, 2011

First Posted

March 10, 2011

Study Start

September 1, 2010

Primary Completion

August 1, 2011

Study Completion

September 1, 2011

Last Updated

November 23, 2011

Record last verified: 2011-11

Locations

GB(1)