Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12624000929505
Ethics application status
Approved
Date submitted
17/07/2024
Date registered
1/08/2024
Date last updated
1/08/2024
Date data sharing statement initially provided
1/08/2024
Type of registration
Retrospectively registered

Titles & IDs
Public title
The appearance of blackcurrant compounds and the inhibition of MAO-B enzyme activity in blood after consuming a single dose of two different blackcurrant beverages in healthy adults
Scientific title
Characterising the effect of blackcurrant beverage format on the bioavailability of blackcurrant phytochemicals and platelet MAO-B enzyme activity in healthy adults
Secondary ID [1] 312547 0
None
Universal Trial Number (UTN)
U1111-1269-9473
Trial acronym
Linked study record
This is a sub-study related to the study registered under ACTRN12621001590853 to determine the most appropriate format to be used in the linked study.

Health condition
Health condition(s) or problem(s) studied:
MAO-B enzyme inhibition 334432 0
Condition category
Condition code
Neurological 331061 331061 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 food format (freeze dried powder or juice concentrate) on inhibiting platelet monoamine oxidase-B activity and bioavailability of blackcurrant anthocyanins and sarmentosin. We will implement a two-arm, randomised, placebo-controlled repeated measures study design. Individuals who have passed the study’s inclusion/exclusion criteria will be asked to attend a familiarisation session (approximately 40 minutes) 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 = 12) will be evenly assigned to the two blackcurrant food formats tested in this study - blackcurrant powder (n = 6; 7.8 mg anthocyanin/kg bodyweight) and blackcurrant juice (n = 6; 78.8 mg anthocyanins). Participants will complete two trial days – one for each treatment (blackcurrant or placebo). Participants will be given a list of foods (e.g. blackcurrants and blackcurrant-containing foods and 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 your scheduled arrival at the research facility for their trial day. Upon arriving on site, participants will be asked what time they consumed their standardised breakfast and self report whether they consumed any of the restricted foods in the list that they were given in the last 24 h. Participants will complete a mood questionnaire, and donate a venous blood sample first blood sample (approximately 18 mL). They will then be given a single serve of their allocated intervention (blackcurrant or placebo) served as a 300 mL drink to consume. Participants will the be asked to complete a mood questionnaire prior donating a venous blood sample at 10 min, 20 min, 2 h, 4 h and 8 h after consuming the intervention. A small meal will be provided to them after the 4 h blood sample collection timepoint. After the blood collection at 8 hour timepoint the Trial Day is finished.

At least five days after their first trial day, participants will complete a second trial day. The second trial day will be the same as the first, except participants will be give the intervention that they did not receive on their first trial day (i.e. the blackcurrant or placebo drink).

The blackcurrant juice and powder are commercially source and prepared in a food-safe facility. Doses used in this study have been used in previous used in nutritional intervention studies (blackcurrant powder) or the current dose of anthocyanins in a commercial blackcurrant juice product (blackcurrant juice).
Intervention code [1] 329064 0
Treatment: Other
Comparator / control treatment
The placebos for the blackcurrant juice and powder interventions will contain similar (but not matched) amount of sugars to the blackcurrant intervention and were commercially produced and provided to by the project’s commercial partner. They will be matched for colour and flavour with a commercial blackcurrant flavouring and food acids to be as similar in flavour and appearance as their corresponding blackcurrant intervention.
Control group
Placebo

Outcomes
Primary outcome [1] 338831 0
Platelet monoamine oxidase-B activity (MAO-B)
Timepoint [1] 338831 0
MAO-B will be measured in platelet samples collected at baseline and 10 min, 20 min, 2 h (primary timepoint), 4 h and 8 h after participants have consumed their allocated intervention
Secondary outcome [1] 437617 0
Composite measures of neurotransmitters - plasma concentrations of up to 35 inhibitory and excitatory neurotransmitters and their precursors associated with the tryptophan, tyrosine and glutamate pathways.
Timepoint [1] 437617 0
Plasma neurotransmitters will be measured in samples collected at baseline and 10 min, 20 min, 2 h, 4 h and 8 h after participants have consumed their allocated intervention on each trial day.
Secondary outcome [2] 437618 0
Subjective measures of mood
Timepoint [2] 437618 0
Mood will be assessed at baseline and 10 min, 20 min, 2 h, 4 h and 8 h after participants have consumed their allocated intervention on each trial day.
Secondary outcome [3] 437619 0
Plasma anthocyanin and sarmentosin concentrations will be measured in plasma samples collected from participants as composite measurements of bioavailabilty and compliance.
Timepoint [3] 437619 0
Bioavailability of anthocyanins and sarmentosin will be measured at baseline and 10 min, 20 min, 2 h, 4 h and 8 h after participants have consumed their allocated intervention on each trial day.

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 have no strong reaction to giving blood samples will be selected for this study.
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 interventions 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. For the primary outcome, ANOVA analysis of 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
Completed
Date of first participant enrolment
Anticipated
Actual
1/04/2022
Date of last participant enrolment
Anticipated
Actual
28/04/2022
Date of last data collection
Anticipated
Actual
28/05/2022
Sample size
Target
12
Accrual to date
Final
13
Recruitment outside Australia
Country [1] 26433 0
New Zealand
State/province [1] 26433 0
MANAWATU

Funding & Sponsors
Funding source category [1] 316973 0
Government body
Name [1] 316973 0
Ministry of Business Innovation and Employment - High Value Nutrition
Country [1] 316973 0
New Zealand
Funding source category [2] 316977 0
Commercial sector/Industry
Name [2] 316977 0
AlphaGen NZ Ltd.
Country [2] 316977 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason - New Zealand Institute for Plant & Food Research
Address
Country
New Zealand
Secondary sponsor category [1] 319221 0
None
Name [1] 319221 0
Address [1] 319221 0
Country [1] 319221 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 315728 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 315728 0
Ethics committee country [1] 315728 0
New Zealand
Date submitted for ethics approval [1] 315728 0
21/10/2021
Approval date [1] 315728 0
18/11/2021
Ethics approval number [1] 315728 0
2021 EXP 11576

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

Contacts
Principal investigator
Name 135618 0
Dr Dominic Lomiwes
Address 135618 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 135618 0
New Zealand
Phone 135618 0
+64 6 3556231
Fax 135618 0
Email 135618 0
[email protected]
Contact person for public queries
Name 135619 0
Dominic Lomiwes
Address 135619 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 135619 0
New Zealand
Phone 135619 0
+64 6 3556231
Fax 135619 0
Email 135619 0
[email protected]
Contact person for scientific queries
Name 135620 0
Dominic Lomiwes
Address 135620 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 135620 0
New Zealand
Phone 135620 0
+64 6 3556231
Fax 135620 0
Email 135620 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.