None listed
Conditions
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.
Interventions
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 fi
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.
Sponsors
Quantec Ltd
Study design
Allocation
Randomised controlled trial
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
25 Years to 62 Years
Healthy volunteers
Yes
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
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.
Outcome results
None listed