Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12623001247662
Ethics application status
Approved
Date submitted
7/11/2023
Date registered
1/12/2023
Date last updated
1/12/2023
Date data sharing statement initially provided
1/12/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
The effect of Comvita propolis supplementation on markers of immune function in healthy adults.
Scientific title
Investigating the effect of acute and chronic Comvita propolis supplementation on immune cell function in healthy adults.
Secondary ID [1] 310914 0
Nil
Universal Trial Number (UTN)
U1111-1299-2261
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune function 331976 0
Condition category
Condition code
Inflammatory and Immune System 328714 328714 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
The intervention is an over-the-counter available Comvita propolis product presented in the same gelatine capsule form. The propolis capsules contain cellulose-microcrystalline (bulking agent), propolis extract with 400 mg pure propolis, silicon dioxide, glyceryl monostearate and magnesium stearate (anticaking agents). Participants will be given a number of capsules at the beginning of the study arm to take home and required to consume a single capsule with water daily for six weeks.

Participants will be asked to return any capsules that they did not consume at the end of their supplementation period. Plasma samples collected at the beginning of each trial day will also be measured for specific polyphenols, enabling the detection of non-adherence to dietary restrictions within a minimum of 24 hours before their respective trial day.
Intervention code [1] 327344 0
Treatment: Other
Comparator / control treatment
The placebo capsule will be similar in appearance as the propolis capsule and contain the same constituents (i.e., cellulose-microcrystalline, silicon dioxide, glyceryl monostearate and magnesium stearate) minus except without propolis. Participants will be given a number of capsules at the beginning of the study arm to take home and required to consume a single capsule with water daily for six weeks.
Control group
Placebo

Outcomes
Primary outcome [1] 336520 0
Composite cytokine production of ex-vivo stimulated peripheral immune cells isolated from participants' peripheral blood.
Timepoint [1] 336520 0
Pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.
Secondary outcome [1] 428682 0
Propolis flavonoid bioavailability after consuming a single dose of propolis and after 6 weeks of daily supplementation
Timepoint [1] 428682 0
Pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.
Secondary outcome [2] 428683 0
Composite subjective assessment of general health using validated questions.
Timepoint [2] 428683 0
The Daily Wellness Diary and Wisconsin Upper Respiratory Symptom Survey will be completed by participants daily from their location. Immune Status Questionnaire, MOS 36-item short-from health questionnaire, Pittsburgh sleep quality index, Short Form Profile of Mood States questionnaire and Bond Lader mood scales will be completed pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.
Secondary outcome [3] 428684 0
Composite measure of immune cell types and metabolism status.
Timepoint [3] 428684 0
Pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.
Secondary outcome [4] 428685 0
Comparison of epigenetic changes in immune cells following acute and long-term propolis supplementation. This will be assessed as a composite outcome.
Timepoint [4] 428685 0
Pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.
Secondary outcome [5] 429028 0
Comparison of transciptomic changes in immune cells following acute and long-term propolis supplementation. This will be assessed as a composite outcome.
Timepoint [5] 429028 0
Pre-supplementation, 2 h after consuming the first dose (acute) and after 6 weeks supplementation.

Eligibility
Key inclusion criteria
Participants will be included if they have given written informed consent and are gauged as healthy by self report and their General Health Questionnaire. Participants will be included if their blood parameters do not indicate significant illness for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose, HbA1c.
Minimum age
18 Years
Maximum age
50 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Blood parameters for albumin, alkaline phosphatase, alanine aminotransferase (ALT), aspartate aminotransferase (AST), blood urea, calcium, chloride, creatinine, potassium, sodium, total bilirubin, total protein, glucose and HBA1c being indicative of clinically significant illness. Participants will be excluded if they are unwilling to unable to provide written consent or comply with the study procedures. Participants will also be excluded if they have known hypersensitivity or intolerance to propolis bee stings and/or specific food additives. In addition, participants will be excluded if they are breastfeeding, 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 or (iii) are taking medication that affects the properties of blood (e.g. blood clotting).

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 will be undertaken by a fellow scientist not involved in this study using a computer randomisation function. Treatment capsules will be stored in opaque containers with each participant's unique code.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
The randomisation of participant treatment allocation for each participant will be undertaken by a fellow scientist not involved in this study using the randomisation function in Microsoft Excel. The key to participant treatment allocation will until completion of the trial and sample analysis.
Masking / blinding
Who is / are masked / blinded?



Intervention assignment
Other design features
Phase
Not Applicable
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
5/02/2024
Actual
Date of last participant enrolment
Anticipated
30/04/2024
Actual
Date of last data collection
Anticipated
28/06/2024
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 25955 0
New Zealand
State/province [1] 25955 0

Funding & Sponsors
Funding source category [1] 315176 0
Commercial sector/Industry
Name [1] 315176 0
Comvita New Zealand Limited
Country [1] 315176 0
New Zealand
Primary sponsor type
Individual
Name
Dr Jocelyn Eason
Address
The New Zealand Institute for Plant & Food Research, Batchelar Road Fitzherbert Palmerston North 4474
Country
New Zealand
Secondary sponsor category [1] 317197 0
None
Name [1] 317197 0
Address [1] 317197 0
Country [1] 317197 0
Other collaborator category [1] 282866 0
Individual
Name [1] 282866 0
Dr Gowthami Vangala
Address [1] 282866 0
The New Zealand Institute for Plant & Food Research Batchelar Road Fitzherbert Palmerston North 4474
Country [1] 282866 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 314107 0
Northern B Health and Disability Ethics Committee
Ethics committee address [1] 314107 0
Ethics committee country [1] 314107 0
New Zealand
Date submitted for ethics approval [1] 314107 0
30/11/2023
Approval date [1] 314107 0
01/12/2023
Ethics approval number [1] 314107 0

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

Contacts
Principal investigator
Name 130434 0
Dr Dominic Lomiwes
Address 130434 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130434 0
New Zealand
Phone 130434 0
+64 6 355 6113
Fax 130434 0
Email 130434 0
[email protected]
Contact person for public queries
Name 130435 0
Pramod Gopal
Address 130435 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130435 0
New Zealand
Phone 130435 0
+64 6 953 7678
Fax 130435 0
Email 130435 0
[email protected]
Contact person for scientific queries
Name 130436 0
Dominic Lomiwes
Address 130436 0
The New Zealand Institute for Plant & Food Research Ltd., Batchelar Road, Private Bag 11600, Palmerston North 4442
Country 130436 0
New Zealand
Phone 130436 0
+64 6 355 6113
Fax 130436 0
Email 130436 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 fully funded by our industry partner 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.