Australian Immunity Trial (Trial B): The effect of milk proteins on immune function in healthy young adults

Not Applicable

Recruiting

• Conditions: Immune Function; Gastrointestinal Microbiome; Cognition; Inflammatory and Immune System - Normal development and function of the immune system; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Mental Health - Studies of normal psychology, cognitive function and behaviour

• Registration Number: ACTRN12622000757718
• Lead Sponsor: utrition Research Australia

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2022-05-27
• Last Update Posted: 9 August 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

Humans.
Aged 18-40 years inclusive.
Any sex or gender.
BMI: 18.5-30kg/m2 inclusive.
Can speak and read English.
Consume cow’s milk 3 or more times per week, with at least 250ml consumed in one day.
Agree to limit alcohol consumption to a maximum of 2 standard drinks per day during the study period.
Agree to limit caffeine to two caffeinated beverages per day (one in the morning and one in the afternoon) during the study period.
Agree to avoid nicotine (e.g., via cigarettes, vape, patch, or gum) during the study period.
Agree to avoid prebiotic and probiotic supplements during the study period.
Agree to avoid artificial sweeteners during the study period.
Live in a stable residence and are able to receive and safely store weekly food deliveries throughout the intervention period.

Exclusion Criteria

Unable to provide informed consent.
Participant enrolled in or previously completed any AIM trial studies
Diagnosed with a chronic disease, including autoimmune conditions, kidney or liver disease, cardiovascular disease, and diabetes.
Diagnosed with one or more of the following mental health conditions:
- Major depressive disorder,
- Psychotic disorder such as schizophrenia,
- Anorexia nervosa,
- Bulimia nervosa,
- Substance abuse disorder,
- Bipolar disorder,
- Personality disorder.
History of elevated blood pressure (>140/90mmHg) at rest on 2 or more subsequent occasions, or told by a doctor that the participant has high blood pressure” or hypertension”.
Experienced infectious disease, injury, or trauma in the past 6-months which led to hospitalisation, systemic (oral) steroid, or oral antibiotic prescription.
Pregnant, breastfeeding, or attempting to become pregnant.
Received a tetanus toxoid vaccination within the past 5-years.
Received any other vaccination not previously mentioned in the past 6-months.
Hospitalised within the past 3-months for any reason.
Use of prescribed or recreational drugs, including steroids, CBD or cannabis, NSAIDs, proton-pump-inhibitors, or antihistamines within the past 2-months.
- Paracetamol and ibuprofen are permitted.
- Over-the-counter prescriptions permitted unless otherwise listed above or known to impact immunity and systemic inflammation.
Change of oral contraception within past 6-months or planned change within the study period.
Tobacco used within the past 2-years.
Known or self-diagnosed allergy or intolerance to any food or ingredient.
Seasonal allergy, e.g., rhinitis.
Irritable bowel syndrome (self-diagnosis is valid).
On a self- or healthcare professional prescribed diet (e.g., Paleo diet, vegan, gluten free diet, low sodium diet, FODMAPS diet).
- Red meat vegetarian, lacto-ovo vegetarian, and pescatarian are permitted.
Participated in a biomedical or medical study in the past 3-months; including participation in any AIM trials

Study & Design

• Study Type: Interventional
• Study Design: Not specified