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

Postprandial Blood Glucose Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02962752
• Other study ID #: 28AI4
• Status: Completed
• Phase: N/A
• First received: November 7, 2016
• Last updated: November 9, 2016
• Start date: January 2012
• Est. completion date: May 2013

Study information

• Verified date: November 2016
• Source: Northumbria University
• Contact: n/a
• Is FDA regulated: No
• Health authority: United Kingdom: Research Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 8
• Est. completion date: May 2013
• Est. primary completion date: May 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 35 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Pharmacokinetics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Investigator, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Monoamine Oxidase Inhibitor Activity
• Postprandial Blood Glucose
• Prolactin Levels

Intervention

Dietary Supplement:
• Blackadder Juice

Other:
• Placebo

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Northumbria University	Plant & food Research Ltd

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Primary	Change from baseline peripheral prolactin levels		15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.	No
Secondary	Change from baseline postprandial blood glucose		15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.	No