ANZCTR - Registration

Please note the ANZCTR will be unattended from Friday 20 December 2024 for the holidays. The Registry will re-open on Tuesday 7 January 2025. Submissions and updates will not be processed during that time.

Registering a new trial?

To achieve prospective registration, we recommend submitting your trial for registration at the same time as ethics submission.

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers

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 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]

None

Universal Trial Number (UTN)

Trial acronym

Linked study record

Health condition

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

Immune response to Influenza vaccine

Condition category

Condition code

Infection

Other infectious diseases

Inflammatory and Immune System

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]

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]

Antigen-specific immune responses to the influenza vaccination assessed by vaccine antigen-specific plasma IgG concentration via enzyme linked immunosorbent assay (ELISA).

Timepoint [1]

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]

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]

First visit in one-week run-in period, and week 1, 2, 4, 6, 8 post intervention

Secondary outcome [2]

Ways of consuming the supplement (intervention) via Consumption and General Health Diary and Consumption and Symptoms Diary

Timepoint [2]

Daily over the 8 week intervention period

Secondary outcome [3]

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]

Week 5, 6, 7 and 8 post intervention

Secondary outcome [4]

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]

Daily over the first four weeks post intervention and weekly over 4-8 week post intervention.

Secondary outcome [5]

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]

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

Accrual to date

Final

Recruitment outside Australia

Country [1]

New Zealand

State/province [1]

Auckland

Funding & Sponsors

Funding source category [1]

Commercial sector/Industry

Name [1]

Quantec Ltd

Address [1]

Quantec Ltd
Waikato Innovation Park
Ruakura Road
Hamilton
3216

Country [1]

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]

University

Name [1]

Massey University, School of Health Sciences

Address [1]

School of Health Sciences
Massey University
PO Box 756
Wellington
6140

Country [1]

New Zealand

Secondary sponsor category [2]

University

Name [2]

Massey University, Research and Enterprise

Address [2]

Research and Enterprise
Massey University
Private Bag 11222
Palmerston North
4442

Country [2]

New Zealand

Ethics approval

Ethics application status

Approved

Ethics committee name [1]

Central Health and Disability Ethics Committees

Ethics committee address [1]

Ministry of Health
113 Molesworth Street
PO Box 5013
Wellington 6011

Ethics committee country [1]

New Zealand

Date submitted for ethics approval [1]

19/08/2021

Approval date [1]

10/11/2021

Ethics approval number [1]

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

A/Prof Rachel Page

Address

School of Health Sciences, College of Health,
Massey University
Wellington 6140

Country

New Zealand

Phone

+64 49793462

Fax

r.a.page@massey.ac.nz

Contact person for public queries

Name

Yongsijia (Andrea) Wei

Address

School of Health Sciences,
SNW Extension, Level 3 Massey University, Albany Campus
Auckland 0745

Country

New Zealand

Phone

+64 212268287

Fax

a.wei@massey.ac.nz

Contact person for scientific queries

Name

Rachel Page

Address

School of Health Sciences, College of Health,
Massey University
Wellington 6140

Country

New Zealand

Phone

+64 49793462

Fax

r.a.page@massey.ac.nz

Data sharing statement

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

No/undecided IPD sharing reason/comment

What supporting documents are/will be available?

Doc. No.	Type	Citation	Link	Email	Other Details	Attachment
15367	Ethical 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

Documents were uploaded by study researchers but have since been removed.

Update to Study Results

Doc. No.	Type	Is Peer Reviewed?	DOI	Citations or Other Details	Attachment
4171	Plain language summary	No		High dose (200mg IDP/day) group exhibited a sustai... [More Details]
4817	Other files	No		Page 35	383687-(Uploaded-24-11-2023-12-26-19)-Other results publication.pdf

Documents added automatically

No additional documents have been identified.

Trial Review

Registering a new trial?

Documents added manually

Documents added automatically