NCT Number: NCT02962752
Pharmacodynamic Profile of 'Blackadder' Blackcurrant Juice Effects Upon the Monoamine Axis in Humans
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.
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Notify MeKey information
Age range
18 year–35 year
Sex eligibility
Male
Study type
Interventional
Phase
Not applicable
About this study
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.
Who can participate
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
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
Treatment and study plan
Placebo
OtherPrimary 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
Time frame: 15, 30, 45 60, 100, 120, 150, 180 and 240 minutes and 24h post dose.
Sponsors and collaborators
Lead sponsor
Northumbria University
Other
Collaborators
- Plant & food Research Ltd
Registry information
Important dates
- Study start
- 2012
- Primary completion
- 2013
- Study completion
- 2013
- First posted
- Nov 11, 2016
- Registry last updated
- Nov 11, 2016
OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.
View the official ClinicalTrials.gov record (opens in a new tab)This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.
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