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Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans

NCT ID: NCT02962752

Last Updated: 2016-11-11

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

8 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-01-31

Study Completion Date

2013-05-31

Brief Summary

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The current study uses a double-blind, placebo-controlled, randomised cross- over design to assess the pharmacodynamics of the platelet MAO-B inhibition, plasma prolactin levels and blood glucose levels after consumption of a single serve of 'Blackadder' blackcurrant juice.

Detailed Description

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There is emerging evidence which supports health benefits of consuming blackcurrant fruit, including improvements to cognitive performance, modulation of blood flow, regulation of blood glucose and inhibition of enzymes underpinning normal cognitive function. Of particular relevance is our previous demonstration of inhibition of MAO-A and B after consumption of a New Zealand 'Blackadder' blackcurrant juice drink in man.

In an attempt to establish a "therapeutic window" on which future nutritional interventions can be based, the current study will assess the pharmacodynamics of MAO-B inhibition, plasma prolactin levels and venous blood glucose profile following consumption of the 'Blackadder' blackcurrant juice. The trial will utilise a 500mg dose of the 'Blackadder' juice (equivalent to \~100g of fresh fruit) which was shown to have MAO inhibitory effects in our previous report and effects will be measured in a cohort of healthy male adults.

Conditions

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Monoamine Oxidase Inhibitor Activity Prolactin Levels Postprandial Blood Glucose

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Study Groups

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Blackadder Juice

Cold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight

Group Type EXPERIMENTAL

Blackadder Juice

Intervention Type DIETARY_SUPPLEMENT

Placebo

Sugar, flavour and volume matched placebo control drink.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type OTHER

Interventions

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Blackadder Juice

Intervention Type DIETARY_SUPPLEMENT

Placebo

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Healthy
* Male
* Aged 18-35
* Non- smoker
* No history of metabolic disease

Exclusion Criteria

* Diagnosis of blood-borne disease
* Diagnosed history of any psychiatric disorder
* Aged under 18 or over 35 years
* BMI above 30 kg/m2 or below 17 kg/m2,
* Diagnosis of diabetes or current use of prescription or over-the-counter drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

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Plant & food Research Ltd

UNKNOWN

Sponsor Role collaborator

Northumbria University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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28AI4

Identifier Type: -

Identifier Source: org_study_id