ANZCTR - Registration

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Trial registered on ANZCTR

Registration number

ACTRN12622000850774

Ethics application status

Approved

Date submitted

2/06/2022

Date registered

16/06/2022

Date last updated

16/06/2022

Date data sharing statement initially provided

16/06/2022

Type of registration

Prospectively registered

Titles & IDs

Public title

Polyphenol-rich drink for gut and brain health

Scientific title

The effects of a polyphenol-rich blackcurrant drink on markers of the gut-brain axis in healthy females: A randomised double-blind cross-over intervention trial.

Secondary ID [1]

None

Universal Trial Number (UTN)

U1111-1276-9066

Trial acronym

LINK study

Linked study record

Health condition

Health condition(s) or problem(s) studied:

Neurocognitive disturbances

Gastrointestinal dysbiosis

Condition category

Condition code

Diet and Nutrition

Other diet and nutrition disorders

Mental Health

Studies of normal psychology, cognitive function and behaviour

Oral and Gastrointestinal

Normal oral and gastrointestinal development and function

Intervention/exposure

Study type

Interventional

Description of intervention(s) / exposure

300mL of Arepa performance drink (blackcurrant-based, polyphenol-rich beverage available on the market containing approximately 300mg of anthocyanins, 200mg of L-theanine, and 150mg of Enzogenol) or a taste- and colour-matched 300mL placebo.

Participants will consume one beverage (intervention or placebo) once daily for 4 weeks, and after a 4-week wash-out period the participants will cross over and receive the other treatment. Participants will be instructed to consume the drink every day at any time of day.

Adherence will be monitored through a weekly self-report diary.

Intervention code [1]

Prevention

Comparator / control treatment

The placebo beverage is matched for taste, colour, and macronutrient composition to the Arepa performance drink, but does not contain anthocyanins, L-theanine, or Enzogenol

Control group

Placebo

Outcomes

Primary outcome [1]

Change in stress reactivity to a multi-tasking cognitive stressor (purple multi-tasking framework), measured by Bond-Lader visual analogue mood scales and the State-Trait Anxiety Inventory (State subscale). This is reported as a composite measure.

Timepoint [1]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [1]

Faecal gut microbiota (composition and predicted function), measured by shotgun metagenome sequencing.

Timepoint [1]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [2]

Change in cognitive performance, measured by the purple multi-tasking framework

Timepoint [2]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [3]

Change in sleep quality, measured by the Pittsburgh Sleep Quality Index

Timepoint [3]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [4]

Change in platelet MAO-B activity, measured in a blood sample

Timepoint [4]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [5]

Change in circulating tryptophan metabolite concentrations, measured in a blood sample

Timepoint [5]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [6]

Change in circulating inflammatory marker concentrations (interleukin-6), measured in a blood sample

Timepoint [6]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Secondary outcome [7]

Change in mood, measured by the profile of mood state questionnaires

Timepoint [7]

Baseline and 4 weeks post-intervention commencement, and baseline and 4 weeks post-placebo commencement.

Eligibility

Key inclusion criteria

• Females aged between 18-45 years.
• BMI between 18-30 kg/m2.
• Not pregnant, nor intending to become pregnant during the trial.
• Has access to internet and a computer, smart phone, or tablet.
• Agree not to enroll in another interventional clinical research trial 4 weeks prior to and for the duration of the study period
• Understands, and is willing and able to comply with all study procedures
• Willing and able to provide written informed consent

Minimum age

18 Years

Maximum age

45 Years

Sex

Females

Can healthy volunteers participate?

Yes

Key exclusion criteria

• Treated for anxiety, depression, or psychiatric disorders within the past two years.
• Diagnosed with gastrointestinal disorders (Coeliac disease, ulcerative colitis, Crohn’s disease), or had past major gastrointestinal surgery likely to interfere with study outcomes (e.g., hemi colectomy, ileostomy, colostomy).
• History of neurological disorders (e.g., Epilepsy, Parkinson’s Disease, stroke, serious head trauma), cognitive impairment, cardiovascular diseases or diabetes requiring medication.
• Medication use expected to interfere with normal digestive processes, including proton pump inhibitors, laxatives.
• Antibiotic use in the four weeks prior to the intervention.
• Prebiotic or probiotic supplement use and are not willing to cease intake for four weeks prior to (and duration of) the intervention.
• Herbal extract supplement use expected to interfere with cognition or mood and are not willing to cease use for four weeks prior to (and duration of) the intervention.
• Self-reported alcohol intake exceeding a moderate intake (>15 standard drinks/week).
• Regular use of recreational/illicit drugs
• Sensitivity to the investigational product, or any of the active/inactive ingredients.

Study design

Purpose of the study

Prevention

Allocation to intervention

Randomised controlled trial

Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)

Allocation is concealed through central randomisation by computer.

Methods used to generate the sequence in which subjects will be randomised (sequence generation)

Randomisation sequences will be generated on a 1:1 allocation ratio. An unblinded researcher will use a computer-generated randomisation programme to generate a randomisation table using random block sizes, which will be partitioned by two strata based on participant’s diet quality at baseline (“optimal” or “suboptimal”).

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

A sample size of 40 subjects was calculated based on reported changes in stress following four weeks of intervention with equivalent doses of constituent bio-actives in the Arepa performance drink. A sample size of 35 subjects is estimated to be adequate for a between-group difference of 20% to identify significant differences at a level of 5%. A sample size of 40 will allow for a drop-out rate not exceeding 15%.

Differences in neurocognitive and biochemical markers between treatment groups will be compared using two-way repeated measures ANOVA or non-parametric tests, followed by post-hoc analysis. Differences in markers of the gut microbiota between treatment groups will be evaluated by Kruskal-Wallis and PERMANOVA tests. The relationship between primary and secondary endpoints will be assessed using correlation and multiple regression analyses.

Recruitment

Recruitment status

Not yet recruiting

Date of first participant enrolment

Anticipated

11/07/2022

Actual

Date of last participant enrolment

Anticipated

Actual

Date of last data collection

Anticipated

Actual

Sample size

Target

40

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Government body

Name [1]

New Zealand Ministry of Business Innovation and Employment

Address [1]

15 Stout Street, Wellington 6011
PO Box 1473, Wellington 6140

Country [1]

New Zealand

Primary sponsor type

University

Name

University of Auckland

Address

85 Park Road
Grafton
Auckland, 1023

Country

New Zealand

Secondary sponsor category [1]

None

Name [1]

NA

Address [1]

NA

Country [1]

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
Health and Disability Ethics Committees
133 Molesworth Street, Thorndon
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

27/04/2022

Approval date [1]

27/05/2022

Ethics approval number [1]

2022 EXP 12513

Summary

Brief summary

There is growing awareness that gut health is linked to virtually all aspects of human health, from digestive function to metabolic health, immunity, cognition, and mental wellbeing. At the same time, the prevalence of functional gut disorders is on the rise, thought to result from disturbances to the gut-brain axis.

The Arepa formula has the potential to provide additive benefits along the gut-brain axis. The Neuroberry® blackcurrant cultivar used in the Arepa formula is unique to Aotearoa and is particularly rich in anthocyanins. Anthocyanins are thought to have a proliferative effect on ‘good’ gut bacteria, yet research in humans has been limited to date. Other plant-derived bio-actives in the Arepa formula are known to target stress, anxiety, cognition, and sleep – all of which can have beneficial effects on the gut microbiota and vice versa. 

A systems approach will be used in this research, providing insight into links between the gut microbiome, blood markers, neurocognitive responses, and diet. The researchers aim to determine whether daily consumption of the Arepa performance beverage has a prebiotic effect, improving the gut microbiota composition and its predicted function. This research also aims to tease apart the role of the gut microbiota in mediating the known neurocognitive benefits of Arepa.

Trial website

Trial related presentations / publications

Public notes

Contacts

Principal investigator

Name

Dr Nicola Gillies

Address

Nutrition Department
Faculty of Medical and Health Sciences, University of Auckland
85 Park Road
Grafton
Auckland, 1023

Country

New Zealand

Phone

+64 220878065

Fax

Email

n.gillies@auckland.ac.nz

Contact person for public queries

Name

Nicola Gillies

Address

Nutrition Department
Faculty of Medical and Health Sciences, University of Auckland
85 Park Road
Grafton
Auckland, 1023

Country

New Zealand

Phone

+64 220878065

Fax

Email

n.gillies@auckland.ac.nz

Contact person for scientific queries

Name

Nicola Gillies

Address

Nutrition Department
Faculty of Medical and Health Sciences, University of Auckland
85 Park Road
Grafton
Auckland, 1023

Country

New Zealand

Phone

+64 220878065

Fax

Email

n.gillies@auckland.ac.nz

Data sharing statement

Will individual participant data (IPD) for this trial be available (including data dictionaries)?

Yes

What data in particular will be shared?

All individual participant data (including data dictionaries) collected during the trial will be available after de-identification, along with the study protocol.

When will data be available (start and end dates)?

Data will be available beginning 3 months following the first publication of study results and ending 36 months following publication.

Available to whom?

Data will be available to investigators who provide a methodologically sound proposal approved by the study Steering Committee, for use to achieve the aims in the approved proposal. Proposals should be directed to the principle investigator. To gain access, requests will need to sign a data access agreement

Available for what types of analyses?

For use to achieve the aims in an approved proposal.

How or where can data be obtained?

Proposals should be directed to the principle investigator (n.gillies@auckland.ac.nz). To gain access, requests will need to sign a data access agreement.

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
16276	Study protocol			n.gillies@auckland.ac.nz
16277	Informed consent form			n.gillies@auckland.ac.nz
16278	Ethical approval			n.gillies@auckland.ac.nz

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.