ACTRN12621000017820招募中3 期
Effect of Palmitoylethanolamide (PEA) and Oleoylethanolamide (OEA) Compared to a Placebo on the Gut Microbiome in an Adult Population – A double blind, randomised controlled trial.
适应症
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 入组人数
- 120
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
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years（—）
- 性别
- All
入选标准
- •Male and females aged 18-65 years old
- •Able to provide informed consent
- •BMI 30-40kg/m2
排除标准
- •Unstable or serious illness (e.g. kidney, liver, GIT, heart conditions, diabetes, thyroid gland function, Malignancy, lung conditions, chronic asthma and mood disorders or neurological disorders such as MS)(a).
- •Acute sickness experienced within the past 2 months
- •Current use of medications (e.g. antibiotics) or supplements (e.g. pre- and probiotics) that alter the microbiome or gut health. Any use during the trial will result in exclusion from the study.
- •Active smokers and/or nicotine or drug abuse
- •Chronic alcohol use (>14 alcoholic drinks week)
- •Allergic to any of the ingredients in active or placebo formula
- •Pregnant or lactating woman
- •Females of child bearing potential not using a highly effective form of contraception (b,c) (i.e. methods which result in low failure rate, i.e. less than 1% per year, when used consistently and correctly like the oral contraception pill, birth control implant e.g. implanon) (b,c).
- •People medically prescribed medications that would affect the immune and/or the inflammatory response (e.g. NSAIDs, steroids, antibiotics).
- •Any condition which in the opinion of the investigator makes the participant unsuitable for inclusion
- •Participants who have participated in any other related clinical study during the past 1 month
- •People with cognitive damage
- •People who have or have had treatment for cancer, HIV or chronic use of any dose of steroids (cream, tablet or inhalant) in the past year
- •a An unstable illness is any illness that is currently not being treated with a stable dose of medication or is fluctuating in severity. A serious illness is a condition that carries a risk of mortality, negatively impacts quality of life and daily function and/or is burdensome in symptoms and/or treatments.
- •b Examples of acceptable forms of highly effective contraception include:
- •Established use of oral, injected or implanted hormonal methods of contraception.
- •Placement of an intrauterine device (IUD) or intrauterine system (IUS).
- •Sterilised male partner (with the appropriate post-vasectomy documentation of the absence of sperm in the ejaculate).
- •True abstinence: When this is in line with your preferred and usual lifestyle
- •c Examples of non-acceptable methods of contraception include:
- •Condoms alone or double barrier
- •Periodic abstinence (e.g. calendar, ovulation, symptothermal, post ovulation)
- •Withdrawal
- •Spermicide (as it is not approved as a method of contraception in Australia)
研究者
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