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Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function

Primary Purpose

Cognitive Decline

Status
Completed
Phase
Not Applicable
Locations
United Kingdom
Study Type
Interventional
Intervention
Placebo
60mL tart Montmorency cherry juice
Sponsored by
Northumbria University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Cognitive Decline

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

  • Northumbria University

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

Placebo

60mL of cherry concentrate with 100ml water

Arm Description

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.

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),

Outcomes

Primary Outcome Measures

Changes in Cerebral Blood Flow

Secondary Outcome Measures

Changes in Cognitive Function

Full Information

First Posted
March 2, 2015
Last Updated
November 2, 2015
Sponsor
Northumbria University
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1. Study Identification

Unique Protocol Identification Number
NCT02381860
Brief Title
Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function
Official Title
Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function
Study Type
Interventional

2. Study Status

Record Verification Date
November 2015
Overall Recruitment Status
Completed
Study Start Date
March 2015 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Northumbria University

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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
Detailed Description
Each participant will be required to attend the laboratory on three occasions. The first of these will be an initial screening/training visit, within 14 days of the first active study visit. During the initial visit participants will be provided with written informed consent and screened with regards the study exclusion/inclusion criteria. Training will be given on the cognitive tasks and familiarisation with the study procedures will be provided. Study days: Forty - eight hours prior to each study day, participants will begin dietary restrictions. Participants will then attend the first study day following an overnight fast. A cannula will be inserted and baseline blood samples obtained, baseline measures of cerebral blood flow will be examined using near infrared spectroscopy and its effect on cognitive function using a cognitive demand battery. The relevant drink will then be provided and blood samples and blood flow measures will be taken at hourly intervals (1, 2, 3, and 5h). No additional food or drink will be provided during the study period except for low-nitrate mineral water. After a minimum of 2 weeks, participants will be asked to return to the lab and repeat the procedure with the other drink. Cerebrovascular Responses Cerebral oxygenation will be assessed using near - infrared spectroscopy . Two near-infrared sensors will be placed on the skin over the right and left prefrontal cortex region of the forehead, and the signals were averaged to determine cerebral oxygenation. The sensors will be secured to the skin using double-sided adhesive tape and shielded from ambient light using an elastic bandage. The sensors alternately emit near-infrared light at wavelengths of 730 and 810 nm. Each sensor contains two detectors located at 3 and 4 cm from the emitting source that detect oxygenated and deoxygenated states of Hb to estimate regional O2 saturation based on internal algorithms (Rasmussen et al. 2007). Blood velocity in the middle cerebral artery (MCAV) will be determined using transcranial Doppler sonography. A 2 MHz Doppler probe was positioned over the right middle cerebral artery using previously described search techniques (Aaslid et al. 1982) and will be secured with an adjustable headset (DiaMon, Compumedics DWL). The mean depth for Doppler signals was 51 ± 3 mm. Arterial blood pressure will be recorded with a transducer located at heart level (TruWave, Edwards Lifesciences, Nyon, Switzerland).

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cognitive Decline

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
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.
Arm Title
60mL of cherry concentrate with 100ml water
Arm Type
Active Comparator
Arm Description
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),
Intervention Type
Other
Intervention Name(s)
Placebo
Other Intervention Name(s)
less than 5% "Kia Ora" mixed fruit squash
Intervention Description
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.
Intervention Type
Dietary Supplement
Intervention Name(s)
60mL tart Montmorency cherry juice
Intervention Description
One bolus of 60mL of tart Montmorency concentrate mixed with 100mL of water.
Primary Outcome Measure Information:
Title
Changes in Cerebral Blood Flow
Time Frame
0,1,2,3, and 5 hours
Secondary Outcome Measure Information:
Title
Changes in Cognitive Function
Time Frame
0,1,2,3 and 5 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
40 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: Males and females aged 40-60 years Not currently taking any medication Exclusion Criteria: Those aged <40 or >60 years Currently taking medication
Facility Information:
Facility Name
Northumbria University
City
Newcastle
ZIP/Postal Code
NE18ST
Country
United Kingdom

12. IPD Sharing Statement

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Investigate the Effect of Tart Montmorency Cherry Juice (Prunus Cerasus) on Cerebral Blood Flow and Cognitive Function

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