Monoamine Oxidase Inhibitor ActivityNCT02962752
Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
A study testing Blackadder Juice in people with Monoamine Oxidase Inhibitor Activity and Prolactin Levels, run by Northumbria University.
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. Read more about this study
- Who is it for?
- Ages 18 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Monoamine Oxidase Inhibitor Activity, Prolactin Levels, Postprandial Blood Glucose
- What is being tested?
- Blackadder Juice
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to May 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy
- Male
- Aged 18-35
- Non- smoker
- No history of metabolic disease
Who cannot join
- 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
About this study
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.
Read the 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.
- Being tested
- Blackadder Juice, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Blackadder JuiceDietary supplement
PlaceboOther
| Study group | Role | What they receive |
|---|---|---|
| Blackadder Juice | Experimental | Cold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight Receives: Dietary Supplement: Blackadder Juice |
| Placebo | Placebo comparator | Sugar, flavour and volume matched placebo control drink. Receives: Other: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline Monoamine Oxidase B - Activity
Platelet monamine oxidase- B activity as measured by the Invitrogen amplex red assay
Measured: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Change from baseline peripheral prolactin levels
Measured: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Secondary outcomes (1)
Change from baseline postprandial blood glucose
Measured: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2016 (estimated)
- Study startJan 2012
- Primary completionMay 2013
- Study completionMay 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Monoamine Oxidase Inhibitor ActivityStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Northumbria University
- Sponsor type
- University, hospital or other
- Collaborators
- Plant & food Research Ltd
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02962752
- Sponsor's protocol ID
- 28AI4
- Status last verified
- Nov 2016
- First submitted
- 7 Nov 2016
- Last updated
- 11 Nov 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Nov 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
- ClinicalTrials.gov ID
- NCT02962752
- Acronym / sponsor ID
- 28AI4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Northumbria UniversityUniversity, hospital or other
- Collaborators
- Plant & food Research Ltd
- Study start
- Jan 2012
- Primary completion
- May 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 11 Nov 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Blackadder Juice | Experimental | Dietary Supplement: Blackadder JuiceCold pressed Blackadder blackcurrant juice. Standardised at 500mg of polyphenols per 60kg of body weight |
| Placebo | Placebo comparator | Other: PlaceboSugar, flavour and volume matched placebo control drink. |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Healthy
- Male
- Aged 18-35
- Non- smoker
- No history of metabolic disease
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Blackadder Juice | Dietary supplement | Blackadder Juice |
| Placebo | Other | Placebo |
Primary outcome
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.
1 secondary outcome
Change from baseline postprandial blood glucose
Time frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Nov 2016.
- Individual participant dataSharing planned: No
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
A study testing Blackadder Juice in people with Monoamine Oxidase Inhibitor Activity and Prolactin Levels, run by Northumbria University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Nov 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline Monoamine Oxidase B - Activity (time frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Nov 2016.