Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000021572p
Ethics application status
Submitted, not yet approved
Date submitted
6/11/2023
Date registered
11/01/2024
Date last updated
11/01/2024
Date data sharing statement initially provided
11/01/2024
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of blackcurrants on platelet monoamine-oxidase enzyme activity.
Scientific title
The acute effect of a blackcurrant extract in inhibiting platelet monoamine oxidase-B enzyme activity in healthy adults.
Secondary ID [1] 310898 0
Nil
Universal Trial Number (UTN)
U1111-1299-5318
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Neurotransmitter modulation 331960 0
Condition category
Condition code
Neurological 328686 328686 0 0
Studies of the normal brain and nervous system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will investigate the effect of a proprietary sarmentosin-enriched blackcurrant extract and its effect on MAO-B inhibition and circulating neurotransmitters. The extract is a concentrated syrup that will be reconstituted in 250 mL water and served in opaque drink bottles.

We will implement a randomised, placebo-controlled, repeated measures study design. Prospective participants who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation session where they will meet with the study’s principal investigator. During this session the study’s trial coordinator (Research Associate, approx. 6 years experience in human studies) or the principal investigator (Research Scientist, PhD) will explain the logistics of the trial to them and answer any questions they may have.

Enrolled participants (n = 4) will attend a total of three trial days. Participants will be given a list of foods (e.g. blackcurrant and blackcurrant-containing supplements) to abstain from consuming 24 hours prior each trial day. Participants will be also be asked to refrain from eating any food or drink (other than water) 10 h before the start of their scheduled trial day except for their supplied breakfast (one Almond One Square Meal bar [Cookie Time Ltd.]) that will be provided for them to consume approximately 2 h before their scheduled arrival at the research facility for their trial day. Upon arriving at the research facility, a venous blood sample (approximately 9 mL) will be collected from them. They will then be given a single serve of their allocated intervention (blackcurrant extract (42 mg and 84 mg sarmentosin) or placebo) to consume as quickly as they can. After this, they will be directed to the seating area of the facility to wait. Two hours and 4 h after consuming their allocated intervention, 9 mL of venous blood will be collected from them. After the 4 h blood sample collection is finished, they will be offered a small snack to eat before you leave the facility.

Participants will be scheduled to complete the next trial day at least three days after completing their trial day. The logistics of subsequent trial days will be the same as the first, except they will be given the intervention that they did not receive on the previous trial day/s.
Intervention code [1] 327325 0
Treatment: Other
Comparator / control treatment
The placebo and the blackcurrant extract intervention will contain similar amount of sugars to the blackcurrant interventions. The blackcurrant intervention will contain sarmetosin-enriched blackcurrant extract (syrup) and blackcurrant flavouring made to total volume of 250 mL with water and served in opaque drink bottles. The placebo intervention will also be matched for colour, flavour and sugar made to a volume of 250 mL water and served in opaque drink bottles.
Control group
Placebo

Outcomes
Primary outcome [1] 336498 0
Monoamine Oxidase-B enzyme activity of platelets
Timepoint [1] 336498 0
MAO-B enzyme activity will be measured in platelet samples isolated from whole blood collected at baseline and 2 h (primary endpoint) and 4 h after participants have consumed their allocated dietary intervention.
Secondary outcome [1] 429521 0
Nil
Timepoint [1] 429521 0
Nil

Eligibility
Key inclusion criteria
Healthy individual (male or female) 18 – 50 years who are able to provide written consent to participate when selected for this study, are non-smokers and vapers and are not prescribed psychotropic medication or MAO inhibitors.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Participants will be excluded if they are unwilling to unable to provide written consent or comply with the study procedures. Participants will be excluded if they are pregnant, planning to get pregnant in the immediate future or have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) recent bacterial or viral illness, (iii) are taking medication that affects the properties of blood (e.g. blood clotting) or immune function, (iv) are taking medication for mental health and mood disorders, (v) have a strong fear or dislike of needles and/or the sight of blood, have an aversion to blood sampling, or difficult veins to access.

Participants will be excluded if they have known hypersensitivity or intolerance to blackcurrants or blackcurrant derived foods.

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
The randomisation of participants in both cohorts will be undertaken by a fellow scientist not involved in this study using a computer randomisation function. All recruited participants will then be allocated a random participant code (consisting of numerical and alphabetical characters) containing no information on which order of treatment they were allocated to. To conceal the treatment allocation from the study investigators, those preparing and packaging the treatment interventions for the participants will not be involved in any other component of the study. Further, the constituents for the placebo intervention will be commercially sourced and will be prepared to be as close as possible in appearance and flavour to the blackcurrant interventions. The blackcurrant intervention will be served in in opaque drink bottles to the participants. These measures will be taken to conceal the identity of the interventions to the volunteers and study investigators
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Randomisation of treatment intervention will be conducted by simple randomisation using a randomisation table created by computer software (i.e., randomisation function of Microsoft Excel).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
Data will be expressed as mean +/- standard error. ANOVA analysis MAO-B enzyme activity will be conducted to determine time and treatment effect on platelet MAO-B activity following dietary intervention consumption.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
29/01/2024
Actual
Date of last participant enrolment
Anticipated
29/02/2024
Actual
Date of last data collection
Anticipated
3/05/2024
Actual
Sample size
Target
4
Accrual to date
Final
Recruitment outside Australia
Country [1] 25953 0
New Zealand
State/province [1] 25953 0
Auckland

Funding & Sponsors
Funding source category [1] 315155 0
Government body
Name [1] 315155 0
The New Zealand Institute for Plant and Food Research Limited
Country [1] 315155 0
New Zealand
Funding source category [2] 315161 0
Commercial sector/Industry
Name [2] 315161 0
AlphaGen New Zealand Limited
Country [2] 315161 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
The New Zealand Institute for Plant & Food Research, Batchelar Road, Fitzherbert, Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 317175 0
None
Name [1] 317175 0
Address [1] 317175 0
Country [1] 317175 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 314092 0
Northern B Health and Disability Ethics Committees
Ethics committee address [1] 314092 0
Ethics committee country [1] 314092 0
New Zealand
Date submitted for ethics approval [1] 314092 0
11/12/2023
Approval date [1] 314092 0
Ethics approval number [1] 314092 0

Summary
Brief summary
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 130378 0
Dr Dominic Lomiwes
Address 130378 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130378 0
New Zealand
Phone 130378 0
+64 6 355 6113
Fax 130378 0
Email 130378 0
[email protected]
Contact person for public queries
Name 130379 0
Pramod Gopal
Address 130379 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130379 0
New Zealand
Phone 130379 0
+64 6 953 7678
Fax 130379 0
Email 130379 0
[email protected]
Contact person for scientific queries
Name 130380 0
Dominic Lomiwes
Address 130380 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130380 0
New Zealand
Phone 130380 0
+64 6 355 6113
Fax 130380 0
Email 130380 0
[email protected]

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment
This work is partly industry funded and publicly disclosing individual participant data will violate our confidentiality agreement to protect the intellectual property generated from this study. Furthermore, ethics guidelines for human clinical studies do not allow us to release data that may risk the disclosure of the identity of participants who took part in this study.


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.