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

Not Applicable

Completed

• Conditions: Prolactin Levels; Postprandial Blood Glucose; Monoamine Oxidase Inhibitor Activity
• Interventions: Dietary Supplement: Blackadder Juice; Other: Placebo

• Registration Number: NCT02962752
• Lead Sponsor: Northumbria University

Brief Summary

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

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.

Study Timeline

• Study Start: 2012-01
• Primary Completion: 2013-05
• Study Completion: 2013-05
• Status Verified: 2016-11
• Study First Submitted: 2016-11-07
• Study First Submitted QC: 2016-11-09
• Last Update Submitted: 2016-11-09
• Study First Posted: 2016-11-11
• Last Update Posted: 2016-11-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 8

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Blackadder Juice	Blackadder Juice	Cold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight
Placebo	Placebo	Sugar, flavour and volume matched placebo control drink.

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
Change from baseline postprandial blood glucose	15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.