NCT02725775

Brief Summary

This study is a 10-week intervention study to examine the acute and chronic effects of daily intake of a 100 % orange juice drink vs control drink on cognitive performance. The study aims to determine if there are any benefits of whole orange juice intake on cognitive performance acutely (i.e. an improvement in performance at week 1) and chronically (i.e. an improvement in performance at week 10).

Trial Health

87
On Track

Trial Health Score

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

Enrollment
90

participants targeted

Target at P75+ for not_applicable healthy

Timeline
Completed

Started Mar 2016

Typical duration for not_applicable healthy

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

March 1, 2016

Completed
21 days until next milestone

First Submitted

Initial submission to the registry

March 22, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

April 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2017

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

May 2, 2018

Status Verified

April 1, 2018

Enrollment Period

1 year

First QC Date

March 22, 2016

Last Update Submit

April 30, 2018

Conditions

Healthy

Keywords

Orange Juice, Polyphenol, Cognition

Outcome Measures

Primary Outcomes (1)

  • Immediate and delayed picture recognition

    Primary dependent variable: number of pictures successfully recalled (from 20 presented) immediately following presentation and after a delay consisting of two cognitive tests (Corsi Tapping and Tower of Hanoi).

    Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption

Secondary Outcomes (3)

  • Delayed spatial memory

    Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption

  • Tower of Hanoi (executive function)

    Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption

  • Corsi block tapping test (Executive function and working memory)

    Acute = 3 hours post first consumption. Chronic = After 10 weeks daily consumption

Study Arms (2)

100% OJ

ACTIVE COMPARATOR

240ml 100% Florida Orange Juice consumed on a daily basis for 10 weeks.

Dietary Supplement: 100% Florida OJ

Equicaloric Orange Drink

PLACEBO COMPARATOR

An equicaloric placebo orange drink (containing equivalent dose of sucrose, glucose, fructose, vitamin C and citric acid for flavour) consumed daily for 10 weeks.

Dietary Supplement: Placebo Equicaloric Orange Drink

Interventions

100% Florida OJDIETARY_SUPPLEMENT
100% OJ
Placebo Equicaloric Orange DrinkDIETARY_SUPPLEMENT
Equicaloric Orange Drink

Eligibility Criteria

Age7 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

You may qualify if:

  • Male or female, aged 7-10 years
  • Willingness to consume test drinks during the study (determined by a score of 5 on the taste testing Likert scale for both orange juice drinks \[attached\])
  • Ability to follow verbal and simple written instructions in English
  • Ability to give written consent
  • Normal vision, with appropriate corrective lenses if required
  • Ability to understand cognitive testing instructions and responding requirements

You may not qualify if:

  • Poor general health
  • Colour blindness (to be assessed at screening using Tests for Colour Blindness (Isihara, 1951)
  • Behavioural difficulties or attention disorders (e.g. Attention Deficit Hyperactivity Disorder)
  • Learning disabilities which interfere with the ability to understand written or verbal communications
  • Inability to understand the objective of the cognitive tests, or carry out the tests
  • Any food allergies or intolerances to study drinks
  • Acute illness, or feelings of unwell, within the week prior to testing
  • Current administration of any psychotropic medication or supplementation in the month prior to testing, or during testing
  • Hearing impairment that precludes the ability to follow verbal instructions

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Human Appetite Research Unit, University of Leeds

Leeds, West Yorkshire, LS29JT, United Kingdom

Location

Study Officials

  • Clare Lawton, PhD

    University of Leeds

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

March 22, 2016

First Posted

April 1, 2016

Study Start

March 1, 2016

Primary Completion

March 1, 2017

Study Completion

May 1, 2017

Last Updated

May 2, 2018

Record last verified: 2018-04

Locations

GB(1)