ACTRN12622000755730招募中未知
Effect of milk containing only a2 beta-casein protein plus lactoferrin on immunity and inflammatory markers, gastrointestinal function, and cognitive function as compared to conventional milk which contains a2 and a1 beta-casein and no lactoferrin, in healthy young adults.
utrition Research Australia0 个研究点目标入组 50 人开始时间: 2022年5月26日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 50
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Prevention
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 40 Years（—）
- 性别
- All
入选标准
- •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.
排除标准
- •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
研究者
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