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Clinical Trials/NCT02962752
NCT02962752CompletedNot Applicable

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

Northumbria University0 sites8 target enrollmentStarted: January 2012Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
8
Primary Endpoint
Change from baseline Monoamine Oxidase B - Activity

Study Overview

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 Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Crossover
Primary Purpose
Basic Science
Masking
Triple (Participant, Investigator, Outcomes Assessor)

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
Male
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

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

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

  • Change from baseline postprandial blood glucose(15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.)

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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