NCT02962752

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.

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
8

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2012

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2012

Completed
1.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2013

Completed
3.5 years until next milestone

First Submitted

Initial submission to the registry

November 7, 2016

Completed
4 days until next milestone

First Posted

Study publicly available on registry

November 11, 2016

Completed
Last Updated

November 11, 2016

Status Verified

November 1, 2016

Enrollment Period

1.3 years

First QC Date

November 7, 2016

Last Update Submit

November 9, 2016

Conditions

Monoamine Oxidase Inhibitor ActivityProlactin LevelsPostprandial Blood Glucose

Outcome Measures

Primary Outcomes (2)

  • 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.

  • Change from baseline peripheral prolactin levels

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

Secondary Outcomes (1)

  • Change from baseline postprandial blood glucose

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

Study Arms (2)

Blackadder Juice

EXPERIMENTAL

Cold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight

Dietary Supplement: Blackadder Juice

Placebo

PLACEBO COMPARATOR

Sugar, flavour and volume matched placebo control drink.

Other: Placebo

Interventions

Blackadder JuiceDIETARY_SUPPLEMENT
Blackadder Juice
PlaceboOTHER
Placebo

Eligibility Criteria

Age18 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Healthy
  • Male
  • Aged 18-35
  • Non- smoker
  • No history of metabolic disease

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 7, 2016

First Posted

November 11, 2016

Study Start

January 1, 2012

Primary Completion

May 1, 2013

Study Completion

May 1, 2013

Last Updated

November 11, 2016

Record last verified: 2016-11

Data Sharing

IPD Sharing
Will not share