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Trial registered on ANZCTR


Registration number
ACTRN12625000371493p
Ethics application status
Submitted, not yet approved
Date submitted
27/03/2025
Date registered
28/04/2025
Date last updated
28/04/2025
Date data sharing statement initially provided
28/04/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The dose effect of sarmentosin on platelet MAO-B activity in healthy adult males
Scientific title
Dose-response characterisation of blackcurrant-derived sarmentosin on platelet monoamine oxidase-B enzyme activity in healthy male adults
Secondary ID [1] 314050 0
None
Universal Trial Number (UTN)
U1111-1319-8187
Trial acronym
Linked study record
This is a follow-up study to registration records ACTRN12624000021572, where our results proved sarmentosin, at the two doses tested, temporally inhibited platelet MAO-B activity.

Health condition
Health condition(s) or problem(s) studied:
Monoamine oxidase B inhibition 336798 0
Condition category
Condition code
Neurological 333291 333291 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 sarmentosin-enriched blackcurrant extract and its effect on MAO-B inhibition. The extract is a freeze-dried powder that will be reconstituted in 250 mL water and served in sealed drink bottles. We will implement an unblinded, dose-escalation, placebo-controlled, repeated measures designed. Prospective participants who have passed the study’s the study’s inclusion/exclusion criteria will be asked to attend a familiarisation where they will meet with the study’s principal investigator or trial coordinator. During this session , the study’s trial coordinator (Research Associate, approx. 8 years experience in human dietary intervention 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 = 15) will attend a maximum of nine trial days. Participants will be given a list of foods (e.g. blackcurrant and blackcurrant-containing supplements) to abstain from consuming 18 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. Upon arriving at the research facility, complete a brief questionnaire confirming compliance with the fasting and dietary restrictions. Participants will then complete a mood questionnaire, then a venous blood sample (approximately 20 mL) will be collected from them. They will then be given a single serve of their allocated intervention (sarmentosin drink or placebo) to consume as quickly as they can. Participants will remain in the facility for a 2-hour observation period during which they will continue fasting, except for water provided to them. After 2 hours, participants will be asked to complete the same mood questionnaire they completed when they first arrived, then a second 20 mL venous blood sample will be collected.

After at least three days following their trial day, participants will return to receive the next higher dose of sarmentosin compared to their previous session. This process will continue until all interventions (placebo and up to eight escalating sarmentosin doses) have been completed, with venous blood collections following the same schedule on each trial day.

This is a dose-escalation study in which participants will be asked to consume a placebo (0 mg sarmentosin) on their first trial day, followed by escalating doses of sarmentosin ( 2.5, 5, 10, 20, 30, and 40 mg) on subsequent trial days. If the dose–response curve does not clearly identify the concentration of sarmentosin required to inhibit 50% of MAO-B activity, participants will be asked to return for two additional trial days. On these days, they will receive sarmentosin doses within the 2.5–40 mg range, selected based on the preliminary dose–response data from the initial six doses.
Intervention code [1] 330635 0
Treatment: Other
Comparator / control treatment
The placebo intervention will be colour matched to the sarmentosin interventions using anthocyanin-free food colouring, diluted to 250 mL with water, and served in opaque drink bottles.
Control group
Placebo

Outcomes
Primary outcome [1] 340871 0
Monoamine Oxidase-B enzyme activity of platelets
Timepoint [1] 340871 0
MAO-B enzyme activity will be measured in platelet samples isolated from whole blood collected at baseline and 2 h (primary endpoint) after participants have consumed their allocated dietary intervention.
Secondary outcome [1] 445306 0
Mood: Alertness, Contentment and Calmness
Timepoint [1] 445306 0
Mood will be evaluated at baseline and 2 h after participants have consumed their allocated dietary intervention.
Secondary outcome [2] 445309 0
Subjective Experience Questionniare - Felt effects
Timepoint [2] 445309 0
Participants will complete the questionnaire at baseline and 2 h after they have consumed their allocated dietary intervention.
Secondary outcome [3] 445770 0
Subjective Experience Questionniare - Dislike for felt effects
Timepoint [3] 445770 0
Participants will complete the questionnaire at baseline and 2 h after they have consumed their allocated dietary intervention.
Secondary outcome [4] 445771 0
Subjective Experience Questionniare - Liking for felt effects
Timepoint [4] 445771 0
Participants will complete the questionnaire at baseline and 2 h after they have consumed their allocated dietary intervention.
Secondary outcome [5] 445772 0
Subjective Experience Questionnaire - Focus
Timepoint [5] 445772 0
Participants will complete the questionnaire at baseline and 2 h after they have consumed their allocated dietary intervention.
Secondary outcome [6] 445773 0
Subjective Experience Questionnaire - Overall mood
Timepoint [6] 445773 0
Participants will complete the questionnaire at baseline and 2 h after they have consumed their allocated dietary intervention.
Secondary outcome [7] 446061 0
Sarmentosin concentrations will be determined in plasma samples collected from participants as a measurement of bioavailability.
Timepoint [7] 446061 0
Sarmentosin bioavailability will be measured in plasma samples separated from whole blood collected at baseline and 2 h after participants have consumed their allocated dietary intervention on each trial day.
Secondary outcome [8] 446062 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 [8] 446062 0
Plasma neurotransmitters will be measured in samples collected at baseline and 2 h after participants have consumed their allocated dietary intervention on each trial day.

Eligibility
Key inclusion criteria
Healthy males 18-50 years (BMI less than 40 kg/m2) who are able to provide written consent to participate when selected for this study, are non-smokers/vapers and are not prescribed psychotropic medication or MAO inhibitors.
Minimum age
18 Years
Maximum age
50 Years
Sex
Males
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. Individuals will be excluded if they have any of the following conditions: (i) blood borne diseases (e.g. hepatitis), (ii) are taking medication that affects the properties of blood (e.g. blood clotting), (iii) are taking medication for mental health and mood disorders, (iv) 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, (v) have a chronic illness e.g., cancer, diabetes. Participants interested in this study 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
Non-randomised trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Single group
Other design features
Phase
Not Applicable
Type of endpoint/s
Pharmacodynamics
Statistical methods / analysis
Data will be presented as mean ± standard error. ANOVA will be used to assess the main effects of time and treatment on platelet MAO-B enzyme activity following dietary intervention. The concentration of sarmentosin required to inhibit 50% of MAO-B activity (IC50) will be determined using non-linear regression analysis.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/05/2025
Actual
Date of last participant enrolment
Anticipated
31/05/2025
Actual
Date of last data collection
Anticipated
30/09/2025
Actual
Sample size
Target
15
Accrual to date
Final
Recruitment outside Australia
Country [1] 26916 0
New Zealand
State/province [1] 26916 0
Manawatu

Funding & Sponsors
Funding source category [1] 318556 0
Commercial sector/Industry
Name [1] 318556 0
AlphaGen New Zealand Limited
Country [1] 318556 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason - The New Zealand Institute for Plant & Food Research Ltd.
Address
Country
New Zealand
Secondary sponsor category [1] 320954 0
None
Name [1] 320954 0
Address [1] 320954 0
Country [1] 320954 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317156 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317156 0
Ethics committee country [1] 317156 0
New Zealand
Date submitted for ethics approval [1] 317156 0
22/03/2025
Approval date [1] 317156 0
Ethics approval number [1] 317156 0

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

Contacts
Principal investigator
Name 140190 0
Dr Dominic Lomiwes
Address 140190 0
The New Zealand Institute for Plant & Food Research Ltd., 23 Batchelar Road, Fitzherbert, Turitea 4410
Country 140190 0
New Zealand
Phone 140190 0
+64 6 355 6113
Fax 140190 0
Email 140190 0
[email protected]
Contact person for public queries
Name 140191 0
TC Chadderton
Address 140191 0
The New Zealand Institute for Plant & Food Research Ltd., 293-297 Akersten Street, Port Nelson, Nelson 7010
Country 140191 0
New Zealand
Phone 140191 0
+64 21 839 282
Fax 140191 0
Email 140191 0
[email protected]
Contact person for scientific queries
Name 140192 0
Dominic Lomiwes
Address 140192 0
The New Zealand Institute for Plant & Food Research Ltd., 23 Batchelar Road, Fitzherbert, Turitea 4410
Country 140192 0
New Zealand
Phone 140192 0
+64 6 355 6113
Fax 140192 0
Email 140192 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No
No IPD sharing reason/comment: This work is industry funded and publicly disclosing individual participant data will violate our confidentiality agreement to protect the intellectual property generated from this study with our commercial partner. 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.