NCT02381860

Brief Summary

Scientific studies in humans suggest that diets high in fruit and vegetables may be able to improve some aspects of mental performance such as improving memory and reaction times. One reason that that these improvements may occur is that these compounds contain phytochemicals which may increase blood flow and, therefore, the delivery of oxygen and nutrients to the brain. If this is the case it is possible to measure this increased blood flow by a non-invasive technique called Near Infrared Spectroscopy. The purpose of this study is to examine the effect of a fruit juice on cerebral blood flow and cognitive function

Trial Health

87
On Track

Trial Health Score

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

Enrollment
28

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Mar 2015

Shorter than P25 for not_applicable

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, 2015

Completed
1 day until next milestone

First Submitted

Initial submission to the registry

March 2, 2015

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 6, 2015

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2015

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

November 3, 2015

Status Verified

November 1, 2015

Enrollment Period

4 months

First QC Date

March 2, 2015

Last Update Submit

November 2, 2015

Conditions

Outcome Measures

Primary Outcomes (1)

  • Changes in Cerebral Blood Flow

    0,1,2,3, and 5 hours

Secondary Outcomes (1)

  • Changes in Cognitive Function

    0,1,2,3 and 5 hours

Study Arms (2)

Placebo

PLACEBO COMPARATOR

The PLA supplement consisted of a commercially available, less than 5% fruit, cordial (Protein - Trace, Carbohydrate 260 mg•mL-1, Sodium 0.02 mg•mL-1, Fibre-Trace and Anthocyanins-Trace for colour), mixed with water, whey protein isolate (Arla Foods Ltd., Leeds, UK) and maltodextrin (MyProtein Ltd., Northwich, UK) until matched for carbohydrate and calorie content of the MC.

Other: Placebo

60mL of cherry concentrate with 100ml water

ACTIVE COMPARATOR

One bolus of 60mL of tart Montmorency cherry (MC) juice mixed with 100mL of water. Independent analysis of MC (Atlas Biosciences, 2010) provided the following compositional data; Fat 0.028 mg•mL-1, Protein 31.47 mg•mL-1, Carbohydrate 669.4 mg•mL-1, Cholesterol \< 0.01 mg•mL-1, Sodium 0.691 mg•mL-1, Calcium 0.137 mg•mL-1 and Iron 0.026 mg•mL-1. Additionally, according to the manufacturers guidelines (Cherry Active, Hanworth, UK),

Dietary Supplement: 60mL tart Montmorency cherry juice

Interventions

PlaceboOTHER

One bolus of less than 5% fruit cordial mixed with water, maltodextrin and whey protein isolate to match for carbohydrate and calorie content of the juice.

Also known as: less than 5% "Kia Ora" mixed fruit squash
Placebo

One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.

60mL of cherry concentrate with 100ml water

Eligibility Criteria

Age40 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females aged 40-60 years
  • Not currently taking any medication

You may not qualify if:

  • Those aged \<40 or \>60 years
  • Currently taking medication

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Northumbria University

Newcastle, NE18ST, United Kingdom

Location

MeSH Terms

Conditions

Cognitive Dysfunction

Condition Hierarchy (Ancestors)

Cognition DisordersNeurocognitive DisordersMental Disorders

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

March 2, 2015

First Posted

March 6, 2015

Study Start

March 1, 2015

Primary Completion

July 1, 2015

Study Completion

July 1, 2015

Last Updated

November 3, 2015

Record last verified: 2015-11

Locations