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Completed

NCT Number: NCT02962752

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

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.

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Key information

Age range

18 year–35 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Blackadder Juice

Dietary Supplement

Placebo

Other

Primary outcomes

  1. Change from baseline Monoamine Oxidase B - Activity

    Time frame: 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

  2. Change from baseline peripheral prolactin levels

    Time frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.

Secondary outcomes

  1. Change from baseline postprandial blood glucose

    Time frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.

Sponsors and collaborators

Lead sponsor

Northumbria University

Other

Collaborators

  • Plant & food Research Ltd

Registry information

Important dates

Study start
2012
Primary completion
2013
Study completion
2013
First posted
Nov 11, 2016
Registry last updated
Nov 11, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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