Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12625000598482p
Ethics application status
Submitted, not yet approved
Date submitted
28/05/2025
Date registered
11/06/2025
Date last updated
11/06/2025
Date data sharing statement initially provided
11/06/2025
Type of registration
Prospectively registered

Titles & IDs
Public title
The effects of a honey and probiotic formulation on digestive symptoms, mood, stress and sleep quality in physically active adults
Scientific title
The effects of a honey and probiotic formulation on digestive symptoms, mood, stress and sleep quality in physically active adults
Secondary ID [1] 314546 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Sleep 337646 0
Anxiety 337647 0
Condition category
Condition code
Mental Health 333972 333972 0 0
Anxiety

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
This study will be a randomised, placebo-controlled, double-blind, crossover trial. There will be two treatment arms: Honey + probiotics (HP) or placebo (glucose syrup). Participants will be required to consume the supplement daily; either once in the morning or once in the evening, for a period of 2 weeks. The HP product contains 4g of manuka honey (UMF 15), 0.96g rewarewa honey, and 35 mg bacillus coagulans probiotics per dose (1 million CFU). There will then be a two-week washout period before supplementing with the alternative (HP or PL) for two-weeks. The HP and PL will be encapsulated in opaque gelatin capsules and will be visually identical to each other. Weekly text messages will be sent to participants to monitor adherence to the supplementation protocols.
Intervention code [1] 331173 0
Treatment: Other
Comparator / control treatment
The control in the study is 5g of plain glucose syrup. The glucose syrup will be encapsulated in opaque gelatin capsules and taken once per day for 14 days.
Control group
Placebo

Outcomes
Primary outcome [1] 341630 0
Changes in Sleep
Timepoint [1] 341630 0
The PSQI will be completed before each intervention arm (pre), 7 days after intervention start (mid) and 14 days post the intervention start (post)
Primary outcome [2] 341631 0
Changes in anxiety
Timepoint [2] 341631 0
Participants will complete the GAD-7 before each intervention arm (pre), at day 7 (mid) and at the end of each intervention arm (day 14 - post).
Secondary outcome [1] 448137 0
Digestive Symptoms
Timepoint [1] 448137 0
Participants will complete the DQLQ before starting each intervention arm (pre), 7 days after supplementing (mid) and at the end of the 14-day supplementation period (post).

Eligibility
Key inclusion criteria
Aged 18 years and over
Exercise > 2.5 hours per week, '
Not currently supplementing with probiotics.
Minimum age
18 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Psychiatric or neurological disorders,
Coeliac disease, lactose intolerance, allergies or other ongoing illnesses (i.e., irritable bowel syndrome, diabetes, ulcerative colitis),
Recent antibiotic treatment (i.e., < 3 months before the beginning of the study).

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 allocation will be determined by computer generated randomisation by an individual independent of the research study. This individual will provide the supplements (intervention and placebo) in numbered containers to ensure allocation will be double-blinded.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Trial order will be prescribed using a computer-generated sequence (https://www.randomizer.org/).
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s

Intervention assignment
Crossover
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
An a priori sample size calculation using G*Power (version 3.1) yielded a minimum sample of 10 participants. Sample size estimation was calculated considering an F-test within-interaction repeated measures, and six collection points (T0, T7, T14), using an effect size of 0.48 observed in previous studies exploring probiotics and mood (Marotto et al., 2019), a error probability of 0.05, and power of 0.95. To account for potential participant drop out and enhance the power of the study, 14 participants will be recruited. Statistical analyses will be conducted using R and GraphPad Prism version 10.3 (GraphPad Software, Boston, Massachusetts USA). Data on questionnaires, will be presented as means and standard deviation and the primary statistical approach employed will be mixed factorial ANOVA with repeated measures on time to assess group (HP vs. PL), time (baseline T0, mid T7, and post T14), and group x time interaction effects. Sidak post hoc comparisons will be conducted upon statistical significance in the mixed factorial ANOVA model. All variables will be tested for normality using results from a Shapiro-Wilk test. Changes from baseline (deltas) will be calculated and independent t-tests computed to evaluate between-group changes using 95% confidence intervals, p-values, and effect sizes for the primary outcome measures. Effects sizes (Cohen’s d) will be used to determine the magnitude of change on all significant post hoc outcomes with a small effect size being equal to or less than 0.2, a medium effect being equal to or less than 0.5, and a large effect being equal to or less than 0.8. Significance will be defined as p < 0.05.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
7/07/2025
Actual
Date of last participant enrolment
Anticipated
11/08/2025
Actual
Date of last data collection
Anticipated
13/10/2025
Actual
Sample size
Target
14
Accrual to date
Final
Recruitment outside Australia
Country [1] 27089 0
New Zealand
State/province [1] 27089 0
Waikato

Funding & Sponsors
Funding source category [1] 319094 0
Government body
Name [1] 319094 0
Callaghan Innovation Poutama Grant
Country [1] 319094 0
New Zealand
Primary sponsor type
University
Name
University of Auckland
Address
Country
New Zealand
Secondary sponsor category [1] 321558 0
None
Name [1] 321558 0
Address [1] 321558 0
Country [1] 321558 0

Ethics approval
Ethics application status
Submitted, not yet approved
Ethics committee name [1] 317694 0
Northern B Health and Disability Ethics Committee 
Ethics committee address [1] 317694 0
Ethics committee country [1] 317694 0
New Zealand
Date submitted for ethics approval [1] 317694 0
28/05/2025
Approval date [1] 317694 0
Ethics approval number [1] 317694 0

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

Contacts
Principal investigator
Name 141834 0
Dr Lillian Morton
Address 141834 0
University of Auckland, Faculty Medical and Health Science, 85 Park Road, Grafton, Auckland, 1023
Country 141834 0
New Zealand
Phone 141834 0
+64 275190375
Fax 141834 0
Email 141834 0
[email protected]
Contact person for public queries
Name 141835 0
Lillian Morton
Address 141835 0
University of Auckland, Faculty Medical and Health Science, 85 Park Road, Grafton, Auckland, 1023
Country 141835 0
New Zealand
Phone 141835 0
+64 275190375
Fax 141835 0
Email 141835 0
[email protected]
Contact person for scientific queries
Name 141836 0
Dr Lillian Morton
Address 141836 0
University of Auckland, 85 Park Road, Grafton, Auckland, 1023
Country 141836 0
New Zealand
Phone 141836 0
+64 275190374
Fax 141836 0
Email 141836 0
[email protected]

Data sharing statement
Will the study consider sharing individual participant data?
Yes
Will there be any conditions when requesting access to individual participant data?
Persons/groups eligible to request access:
• Researchers
Conditions for requesting access:
• Yes, conditions apply:
• Requires review on a case-by-case basis by the trial custodian, sponsor or data sharing committee
• Requires a scientifically sound proposal or protocol
• Requires approval by an ethics committee
What individual participant data might be shared?
• De-identified individual participant data:
• Published results
• Safety data
What types of analyses could be done with individual participant data?
• Systematic reviews and meta-analyses
• Studies testing whether findings can be repeated or confirmed
When can requests for individual participant data be made (start and end dates)?
From:
After publication of main results
To:
No end date
Where can requests to access individual participant data be made, or data be obtained directly?
• Journal publication or its supplementary materials: To be determined

• Email of trial custodian, sponsor or committee: Requests can be emailed to the primary researcher [email protected]

Are there extra considerations when requesting access to 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.