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Trial registered on ANZCTR


Registration number
Help: Registration number
ACTRN12626001163392p
Ethics application status
Help: Ethics application status
Not yet submitted
Date submitted
Help: Date submitted
31/08/2026
Date registered
Help: Date registered
18/09/2026
Date last updated
Help: Date last updated
18/09/2026
Date data sharing statement initially provided
Help: Data sharing statement date
18/09/2026
Type of registration
Help: Type of registration
Prospectively registered

Titles & IDs
Public title
How sarmentosin from blackcurrants is absorbed, metabolised and excreted by the body.
Scientific title
A placebo-controlled crossover study to characterise the pharmacokinetics of sarmentosin in a blackcurrant extract in healthy adults.
Additional trial identifiers [1] 318290 0
Nil
Universal Trial Number (UTN)
U1111-1344-9253
Trial acronym
BOOST
Related trial records

Health condition
Health condition(s) studied:
Nutrient absorption 343417 0
Mood disturbances 343418 0
Condition category
Condition code
Diet and Nutrition 339496 339496 0 0
Other diet and nutrition disorders
Mental Health 339497 339497 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of the intervention or exposure
There are two components to this study.

The first is a Pilot study, which will be used to identify sarmentosin metabolites that will be targeted in the main dietary intervention study. The Pilot study will also be used to determine the number of participants required for the Dietary intervention study.

PILOT STUDY
There is only one arm, which spans 48 hours. The intervention is a blackcurrant extract providing 100 mg of sarmentosin dissolved in 250 mL of water.

The intervention will be delivered face-to-face by a research associate who has many years experience in participant management during clinical studies.

Participants will be supervised by a member of the research team to monitor adherence.

Participants will remain on site for the initial four hours of the study arm, There are additional timepoints at 8, 12, 24 and 48 hours. Participants may leave the facility after the 4-hour timepoint but must ensure that they return well before each subsequent sampling time.

All visits will take place at the Bioeconomy Science Institute's clinical facility.

DIETARY INTERVENTION STUDY

As no comprehensive pharmacokinetic data are available for blackcurrant-derived (BC-derived) sarmentosin and its metabolites, a reliable a priori sample size calculation is not possible. Accordingly, this study incorporates an adaptive design in which the sample size for the main Dietary Intervention Study will be estimated using data obtained from the initial Pilot Study. Specifically, results from the Pilot Study on the appearance and clearance of sarmentosin and its metabolites in plasma from at least five participants (n = 5) will be used to estimate inter-individual variability. These data will then be used to determine the sample size required for the Dietary Intervention Study, targeting an inter-individual coefficient of variation of =20% for key pharmacokinetic parameters.

This is a two arm, randomised crossover study which includes two study arms separated by a washout period of at least five days. For one of the study arms, participants will consume the following intervention.

Intervention 2 - a blackcurrant extract providing 100 mg of sarmentosin dissolved in 250 mL of water.

By the end of the study, participants will have received both study interventions. Each study arm spans 48 hours. Participants are expected to consume their intervention as soon as possible.

The intervention will be delivered face-to-face by a research associate who has many years experience in participant management during clinical studies.

Participants will be supervised by a member of the research team to monitor adherence.

Participants will remain on site for the initial 4 hours of the study arm, There are additional timepoints at 8, 12, 24 and 48 hours. Participants may leave the facility after the 4-hour timepoint but must ensure that they return well before each subsequent sampling time.

All visits will take place at the Bioeconomy Science Institute's clinical facility.
Intervention code [1] 335187 0
Treatment: Other
Description of the comparator or control
DIETARY INTERVENTION STUDY
Intervention 1 - 250 mL water matched in colour and flavour to the sarmentosin intervention.

The intervention will be delivered face-to-face by a research associate who has many years experience in participant management during clinical studies.

Participants will be supervised by a member of the research team to monitor adherence.

Participants will receive the placebo intervention one time only. Sampling for this arm will span 48 hours. All visits will take place at the Bioeconomy Science Institute's clinical facility.
Control group
Placebo

Outcomes
Primary outcome [1] 346687 0
PILOT STUDY Identification and quantification of sarmentosin metabolites in plasma and urine samples Assessed together as a composite primary outcome
Timepoint [1] 346687 0
Baseline (0 hours), 1, 2, 4, 8, 12 and 24 hours post consumption of intervention
Primary outcome [2] 346700 0
DIETARY INTERVENTION STUDY To characterise the bioavailability, metabolism and excretion of targeted sarmentosin metabolites in plasma and urine identified in the pilot study Assessed together as a composite primary outcome
Timepoint [2] 346700 0
Baseline (0 hours), 1, 2, 4, 8, 12 and 24 hours post consumption of intervention
Secondary outcome [1] 467073 0
PILOT STUDY Identification and quantification of sarmentosin metabolites in faeces samples Assessed together as a composite secondary outcome
Timepoint [1] 467073 0
Baseline (0 hours), 24 and 48 hours post consumption of intervention
Secondary outcome [2] 467074 0
PILOT STUDY Liver and kidney function Assessed together as a composite secondary outcome
Timepoint [2] 467074 0
Baseline (0 hours) and 24 hours post consumption of intervention
Secondary outcome [3] 467075 0
PILOT STUDY Any effects felt by participants following consumption of the intervention
Timepoint [3] 467075 0
1, 2, 4, 8, 12 and 24 hours post consumption of intervention
Secondary outcome [4] 467076 0
PILOT STUDY Changes in participants physical and mental wellbeing that they may attribute to the study intervention Assessed together as a composite secondary outcome
Timepoint [4] 467076 0
48 hours post consumption of intervention
Secondary outcome [5] 467077 0
DIETARY INTERVENTION STUDY To characterise the bioavailability, metabolism and excretion of targeted sarmentosin metabolites in faeces identified in the pilot study Assessed together as a composite secondary outcome
Timepoint [5] 467077 0
Baseline (0 hours), 24 and 48 hours post consumption of intervention
Secondary outcome [6] 467078 0
DIETARY INTERVENTION STUDY Liver and kidney function Assessed together as a composite secondary outcome
Timepoint [6] 467078 0
Baseline (0 hours) and 24 hours post consumption of intervention
Secondary outcome [7] 467079 0
DIETARY INTERVENTION STUDY Mood
Timepoint [7] 467079 0
Baseline (0 hours), 1, 2, 4, 8, 12 and 24 hours post consumption of intervention
Secondary outcome [8] 467080 0
DIETARY INTERVENTION STUDY Heart rate variability
Timepoint [8] 467080 0
Continuously during first 12 hours of each study arm
Secondary outcome [9] 467081 0
DIETARY INTERVENTION STUDY Changes in participants' physical and mental wellbeing that they may attribute to the study intervention Assessed together as a composite secondary outcome
Timepoint [9] 467081 0
48 hours post consumption of intervention
Secondary outcome [10] 467082 0
DIETARY INTERVENTION STUDY Blood pressure
Timepoint [10] 467082 0
Baseline (0 hours), 1, 2, 4, 8, 12 and 24 hours post consumption of intervention

Eligibility
Key inclusion criteria
An individual of any sex aged 18 - 50 years
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Healthy volunteers
Yes
Key exclusion criteria
They will also be excluded if they are allergic to, or intolerant of, blackcurrants or blackcurrant-derived foods. In addition, volunteers will be excluded if they are pregnant, planning to get pregnant in the near future or are breast feeding. They must not have any of the following: (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), (iv) have a strong fear or dislike of needles and/or the sight of blood, or have veins that are difficult to access, (v) have a chronic illness (e.g. cancer), (vi) are taking medication for weight loss (e.g. Wegovy, Ozempic, Saxenda), (vii) are taking medication for mental health or mood disorders, (viii) donated blood to the blood bank within four weeks of starting the study. Volunteers who smoke or vape are ineligible to take part.

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)
Allocation is concealed by central randomisation.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation using a randomisation table created by computer software.
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s


The people analysing the results/data
Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis
PILOT STUDY
n = 5 was decided on because that is sufficient to identify sarmentosin metabolites and determine if they are bioavailable.

DIETARY INTERVENTION STUDY
This is an adaptive study. Data from the Pilot study will be used to estimate the sample size required to characterise the pharmacokinetic profiles of sarmentosin and related metabolites in plasma and urine, targeting a coefficient of variation of 20% between individuals for key measures of appearance and clearance.

All study data will be captured on study-specific worksheets and transcribed to an access-restricted database maintained by BSI. Analysed data will be presented as mean values and standard errors of the mean. Statistical significance for the comparison between timepoints and intervention groups will be assessed using analysis of variance (ANOVA) from a linear mixed effects model with fixed effects for treatment and time, and their interaction, and random effects for participant. Statistical significance for all indices will be set at P < 0.05 with a confidence level of 95%.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
1/10/2026
Actual
Date of last participant enrolment
Anticipated
1/12/2026
Actual
Date of last data collection
Anticipated
21/12/2026
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 28477 0
New Zealand
State/province [1] 28477 0

Funding & Sponsors
Funding source category [1] 322845 0
Commercial sector/Industry
Name [1] 322845 0
AlphaGen Ltd
Country [1] 322845 0
New Zealand
Funding source category [2] 322846 0
Other Collaborative groups
Name [2] 322846 0
Bioeconomy Science Institute
Country [2] 322846 0
New Zealand
Primary sponsor type
Other Collaborative groups
Name
Bioeconomy Science Institute
Address
Country
New Zealand
Secondary sponsor category [1] 325779 0
None
Name [1] 325779 0
Address [1] 325779 0
Country [1] 325779 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 321283 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 321283 0
Ethics committee country [1] 321283 0
New Zealand
Date submitted for ethics approval [1] 321283 0
21/09/2026
Approval date [1] 321283 0
Ethics approval number [1] 321283 0

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

Contacts
Principal investigator
Name 153242 0
Dr Dominic Lomiwes
Address 153242 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North, 4410
Country 153242 0
New Zealand
Phone 153242 0
+64 06 355 6113
Fax 153242 0
Email 153242 0
[email protected]
Contact person for public queries
Name 153243 0
Dominic Lomiwes
Address 153243 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North, 4410
Country 153243 0
New Zealand
Phone 153243 0
+64 06 355 6113
Fax 153243 0
Email 153243 0
[email protected]
Contact person for scientific queries
Name 153244 0
Dominic Lomiwes
Address 153244 0
Bioeconomy Science Institute, 23 Batchelar Road, Fitzherbert, Palmerston North, 4410
Country 153244 0
New Zealand
Phone 153244 0
+64 06 355 6113
Fax 153244 0
Email 153244 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
No



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.