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Trial registered on ANZCTR


Registration number
ACTRN12622000462785
Ethics application status
Approved
Date submitted
14/03/2022
Date registered
24/03/2022
Date last updated
25/09/2023
Date data sharing statement initially provided
24/03/2022
Date results information initially provided
7/03/2023
Type of registration
Prospectively registered

Titles & IDs
Public title
Pilot study: Can a dairy based protein (IDP) enhance immune responses after influenza vaccination?
Scientific title
A double-blinded randomised placebo controlled pilot study investigating impact of a dairy based protein complex (IDP) on immune responses after influenza vaccination, in healthy subjects
Secondary ID [1] 306587 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Immune response to Influenza vaccine 325482 0
Condition category
Condition code
Infection 322866 322866 0 0
Other infectious diseases
Inflammatory and Immune System 322867 322867 0 0
Normal development and function of the immune system

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A powdered dairy supplement containing immune defense protein (200mg of IDP each 2g sachet). The supplement will be consumed with breakfast daily for 8 weeks.

A one-week run-in period will precede the intervention stage, for baseline measurements using a short health screening questionnaire and measurement of height, weight and blood pressure. No supplement is consumed in the run-in week.
Participants will be asked to fill out a daily consumption and general health questionnaire during the first 4 weeks of intervention period asking if and how the intervention has been consumed, which will serve as a reminder to take their intervention. After 4 weeks of intervention participants will be vaccinated with the influenza vaccine developed according to World Health Organisation (WHO) guidelines for 2023 and approved by Medsafe, New Zealand. Vaccines will be administered intramuscularly in the deltoid region of the arm by trainned personnel as part of this study. Participants will be asked to fill out a daily sysptom-related weekly questionnaire during 4-8 weeks of the intervention period and a short questionnaire on consumption of the supplement at the end of the study.
Intervention code [1] 323014 0
Treatment: Other
Comparator / control treatment
A placebo powder is used as a control and will be weight-matched to the active intervention. The control contains no known bioactive ingredients. The placebo powder is commercially supplied by Quantec Limited. The placebo powder will be given daily for 8 weeks, to consume with breakfast.
Participants assigned to the control group will be subject to the same trial activities as the active intervention. Such as one-week run-in period before placebo intervention stage, daily consumption and general health questionnaire for the first four weeks of placebo intervention, weekly consumption and symptoms questionnaire during Week 5-8, after receiving the influenza vaccine at Week 4 and a short questionnaire on consumption of the supplement at the end of the study.
Control group
Placebo

Outcomes
Primary outcome [1] 330720 0
Antigen-specific immune responses to the influenza vaccination assessed by vaccine antigen-specific plasma IgG concentration via enzyme linked immunosorbent assay (ELISA).
Timepoint [1] 330720 0
Six visits (Day 0 is the initiation of intervention)
1. First visit in one-week run-in period (one day of Day -7 to Day 0),
2. Second visit in week 1 post-intervention (Day 07),
3. Third visit in week 2 post-intervention (Day 14)
4. Fourth visit in week 4 post-intervention (Day 28)
5. Fifth visit in week 6 post-intervention (Day 42)
6. Sixth visit in week 8 post-intervention (Day 56)
Secondary outcome [1] 407304 0
Plasma concentration of inflammatory markers, including Interleukin-6 (IL-6), Interleukin-10 (IL-10), interferon and Tumour Necrosis Factor alpha (TNF alpha) via enzyme linked immunosorbent assay (ELISA). This was collected for the 2022 participants only, and will not be collected for 2023 participants.
Timepoint [1] 407304 0
First visit in one-week run-in period, and week 1, 2, 4, 6, 8 post intervention
Secondary outcome [2] 407398 0
Ways of consuming the supplement (intervention) via Consumption and General Health Diary and Consumption and Symptoms Diary
Timepoint [2] 407398 0
Daily over the 8 week intervention period
Secondary outcome [3] 407399 0
Any changes in responses after receiving influenza vaccination with consumption of the active intervention or the placebo via the Weekly Consumption and Symptoms Diary.
Timepoint [3] 407399 0
Week 5, 6, 7 and 8 post intervention
Secondary outcome [4] 407400 0
Any changes in general health related to the consumption of supplement (Intervention) via Consumption and General Health Diary and Consumption and Symptoms Diary.
Timepoint [4] 407400 0
Daily over the first four weeks post intervention and weekly over 4-8 week post intervention.
Secondary outcome [5] 407401 0
Comments on various aspects of the supplement, including taste, convenience, amount, texture, and form (powder) of the supplement via Questionnaire on Supplement Consumed.
Timepoint [5] 407401 0
Week 8 post intervention.

Eligibility
Key inclusion criteria
Age: 25-62 years of age
Sex: Female and male
Health: Healthy as gauged by self-assessment and not having any chronic inflammatory conditions
Agreement: Participants have given written informed consent to the study.
Able to speak and read English
Minimum age
25 Years
Maximum age
62 Years
Sex
Both males and females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Lactose intolerance; known or suspected allergy to dairy products, starch, gluten or artificial sweeteners;
Participation in another clinical trial;
Pregnancy or currently lactating; have had flu vaccination recently;
Had anaphylaxis reaction to influenza vaccination;
Had already received the influenza vaccination in 2022;
Had a recent cold (three weeks prior to the first visit);
Have any chronic inflammatory conditions.

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)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
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
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Stopped early
Data analysis
Data collected is being analysed
Reason for early stopping/withdrawal
Other reasons/comments
Other reasons
Moving out of flu season 2023 so it would be less efficient for further recruitment. And we are satisfied with the current sample size.
Date of first participant enrolment
Anticipated
31/03/2022
Actual
11/04/2022
Date of last participant enrolment
Anticipated
10/10/2023
Actual
7/08/2023
Date of last data collection
Anticipated
5/12/2023
Actual
7/09/2023
Sample size
Target
60
Accrual to date
Final
53
Recruitment outside Australia
Country [1] 24654 0
New Zealand
State/province [1] 24654 0
Auckland

Funding & Sponsors
Funding source category [1] 310918 0
Commercial sector/Industry
Name [1] 310918 0
Quantec Ltd
Country [1] 310918 0
New Zealand
Primary sponsor type
Commercial sector/Industry
Name
Quantec Ltd
Address
Quantec Ltd
Waikato Innovation Park
Ruakura Road
Hamilton
3216
Country
New Zealand
Secondary sponsor category [1] 312212 0
University
Name [1] 312212 0
Massey University, School of Health Sciences
Address [1] 312212 0
School of Health Sciences
Massey University
PO Box 756
Wellington
6140
Country [1] 312212 0
New Zealand
Secondary sponsor category [2] 312288 0
University
Name [2] 312288 0
Massey University, Research and Enterprise
Address [2] 312288 0
Research and Enterprise
Massey University
Private Bag 11222
Palmerston North
4442
Country [2] 312288 0
New Zealand

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 310477 0
Central Health and Disability Ethics Committees
Ethics committee address [1] 310477 0
Ministry of Health
113 Molesworth Street
PO Box 5013
Wellington 6011
Ethics committee country [1] 310477 0
New Zealand
Date submitted for ethics approval [1] 310477 0
19/08/2021
Approval date [1] 310477 0
10/11/2021
Ethics approval number [1] 310477 0
21/CEN/233

Summary
Brief summary
Immune Defense Proteins (IDP) is a complex of milk proteins that has been shown to have anti-inflammatory activity, and also have antimicrobial, antioxidant and antiviral activity. IDP is a product that has been present in the marketplace for over 10 years. The effect of IDP on enhancing immune response after an influenza vaccination in humans has not been shown.
The objective of this project is to conduct a pilot study examining the impact of IDP on IgG response after influenza vaccination has been administered to healthy 25-62 year-olds. This pilot study will be evaluating how the study design can be improved upon prior to a larger scale research study. The study will be a double-blinded randomised placebo-controlled trial. Twenty subjects will be randomised per trial arm and there will be two arms to the trial – placebo, and 200 mg IDP.
Daily consumption of Placebo or IDP (200 mg) will occur over 8 weeks. At 4 weeks the participants will receive the flu vaccination. Blood samples will be collected throughout the trial for measurement of influenza-specific IgG. Appropriate diaries will be provided for participants to discuss their well-being throughout the trial, how they consumed the product they were given and what they thought of the supplementation.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 117806 0
A/Prof Rachel Page
Address 117806 0
School of Health Sciences, College of Health,
Massey University
Wellington 6140
Country 117806 0
New Zealand
Phone 117806 0
+64 49793462
Fax 117806 0
Email 117806 0
r.a.page@massey.ac.nz
Contact person for public queries
Name 117807 0
Miss Yongsijia (Andrea) Wei
Address 117807 0
School of Health Sciences,
SNW Extension, Level 3 Massey University, Albany Campus
Auckland 0745
Country 117807 0
New Zealand
Phone 117807 0
+64 212268287
Fax 117807 0
Email 117807 0
a.wei@massey.ac.nz
Contact person for scientific queries
Name 117808 0
A/Prof Rachel Page
Address 117808 0
School of Health Sciences, College of Health,
Massey University
Wellington 6140
Country 117808 0
New Zealand
Phone 117808 0
+64 49793462
Fax 117808 0
Email 117808 0
r.a.page@massey.ac.nz

Data sharing statement
Will individual participant data (IPD) for this trial be available (including data dictionaries)?
No
No/undecided IPD sharing reason/comment


What supporting documents are/will be available?

Doc. No.TypeCitationLinkEmailOther DetailsAttachment
15367Ethical approval    383687-(Uploaded-14-03-2022-08-09-54)-Study-related document.pdf



Results publications and other study-related documents

Documents added manually
Current Study Results
No documents have been uploaded by study researchers.

Update to Study Results
Doc. No.TypeIs Peer Reviewed?DOICitations or Other DetailsAttachment
4171Plain language summaryNo High dose (200mg IDP/day) group exhibited a sustai... [More Details]
4817Other filesNo Page 35 383687-(Uploaded-24-11-2023-12-26-19)-Other results publication.pdf

Documents added automatically
No additional documents have been identified.