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

Study Overview
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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.

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

Conditions
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Monoamine Oxidase Inhibitor Activity, Prolactin Levels, Postprandial Blood Glucose

Intervention / Treatment
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* Dietary Supplement: Blackadder Juice
* Other: Placebo


Participation Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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Male

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Basic Science
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Blackadder Juice<br>Cold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight | Dietary Supplement: Blackadder Juice<br> <br> |
| Placebo Comparator: Placebo<br>Sugar, flavour and volume matched placebo control drink. | Other: Placebo<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline Monoamine Oxidase B - Activity | Platelet monamine oxidase- B activity as measured by the Invitrogen amplex red assay | 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose. | 
| Change from baseline peripheral prolactin levels |  | 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change from baseline postprandial blood glucose |  | 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose. |