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

November 9, 2016 updated by: Northumbria University
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

8

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Change from baseline peripheral prolactin levels
Time Frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Northumbria University

Collaborators

Plant & food Research Ltd

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2012

Primary Completion (Actual)

May 1, 2013

Study Completion (Actual)

May 1, 2013

Study Registration Dates

First Submitted

November 7, 2016

First Submitted That Met QC Criteria

November 9, 2016

First Posted (Estimate)

November 11, 2016

Study Record Updates

Last Update Posted (Estimate)

November 11, 2016

Last Update Submitted That Met QC Criteria

November 9, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Other Study ID Numbers

  • 28AI4

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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