ISRCTN14120894进行中(未招募)未知
The effects of a prebiotic supplement on quality of life, control of asthma, and markers of systemic inflammation in adults with asthma: a double-blind, placebo-controlled, crossover trial
ottingham Trent University0 个研究点目标入组 15 人开始时间: 2021年5月19日最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 进行中(未招募)
- 发起方
- 入组人数
- 15
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- All
入选标准
- •1. Aged 18-50 years of age
- •2. Body mass index (BMI) of 18.5-35 kg·m²
- •3. Non-smoker
- •4. Asthma severity defined as Steps 1 to 5 based on British Thoracic Society guidelines
- •5. Current asthma diagnosis and medication prescription from GP (e.g. maintenance and reliever inhalers)
- •6. In the researcher’s opinion, able and willing to follow all the trial requirements
- •7. Potential participants must disclose any nutritional supplements they take to the researcher, to determine whether these may be considered as exclusion criteria
排除标准
- •1. Suffer from asthma but do not have a current medication prescription from GP (e.g. maintenance and reliever inhalers)
- •2. Regularly consume Omega-3 supplements, and/or eat high levels of Omega-3 (e.g. more than 1-2 portions of oily fish such as salmon or mackerel a week).
- •3. Take aspirin or other non-steroidal anti-inflammatory drugs such as ibuprofen once a day on 5 of the 7 days of the week
- •4. Females only: pregnant or planning a pregnancy during the time of the study (on each visit participants will be asked to complete a pregnancy test if within childbearing age)
- •5. Consumed prebiotics and/or probiotics (supplements), drugs that affect gastrointestinal mobility or laxatives in the 4 weeks before signing the consent form
- •6. Vegetarian or vegan diet
- •7. Previously diagnosed with chronic obstructive pulmonary disease (COPD), emphysema, chronic bronchitis, or similar respiratory (breathing-related) illness
- •8. Admitted to hospital during the past 12 months for asthma
- •9. History of heart failure, pulmonary hypertension, embolism, or other pulmonary heart disease
- •10. History of recurrent chest infections
- •11. Acute infection in the last 4 weeks and/or major operation in the past 4 months
- •12. History of gastrointestinal drug reaction
- •13. Taken antibiotics in the past 3 months
- •14. History or current evidence of gastrointestinal disease (e.g. chronic constipation, diarrhoea, irritable bowel syndrome, Crohn’s disease)
- •15. Recently taken part in other research projects. Please notify the chief investigator
- •16. Are or believe they may be lactose intolerant
- •17. Regularly take antioxidant supplements, such as beta-carotene, vitamin A, vitamin C, vitamin E, lutein and selenium
- •18. Standard multivitamin and mineral supplements are acceptable; however, If a single antioxidant supplement (e.g. Vitamin C) is more than the recommended daily Dietary Reference Values (DRVs) this must be checked with the chief investigator
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