NL-OMON26982尚未招募不适用
Standardized dietary challenge to monitor effects of rehabilitation program in patients with COPD: a pilot study
Ciro0 个研究点目标入组 10 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 10
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
入选标准
- •Objective diagnosis of COPD
- •-Age range from 40-59 year
- •-No carcinogenic events for the last 5 years
- •-Capability to read and understand the study protocol
- •-N=10 lean body composition: BMI between 20 and 25 kg/m2 with a normal FFMI (> percentile 5 according to Franssen et al. ) and without metabolic syndrome).
- •-N=10 with metabolic syndrome according to international criteria.
排除标准
- •-Clinically important pulmonary disease other than COPD (e.g. but not limited to active lung infection, clinically significant bronchiectasis, pulmonary fibrosis, lung cancer, asthma as primary or main diagnosis) or other pulmonary disorder as judged by the Investigator.
- •-An increase in complaints of the lungs defined by a physician as an exacerbation COPD within 4 weeks of the routine baseline assessment and between the period of routine baseline assessment and the first test day.
- •-Participation in an investigational drug within 3 months prior to screening.
- •-Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study.
- •-Average alcohol consumption > 21 units/week.
- •-Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments.
- •oUse of non-steroidal anti-inflammatory drugs (NSAIDs) (i.e. ibuprofen, aspirin), statins, and beta-blockers is not allowed during the evening before and during the test days. Patients are eligible after approval by the doctor to stop the abovementioned medication the evening before and during the nutritional challenge test days.
- •-Reported food allergy or sensitivity for one of the used ingredients of the Phenflex shake.
- •-Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner.
- •-Unintentional weight loss or gain > 5% body weight in the last month.
- •-Clinically significant abnormalities, as judged by the investigator, in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated once before determination of eligibility. This will be judged by the physician.
- •-Inappropriate veins for cannula insertion.
- •-Having a chronic auto-immune disease (such as arthritis).
- •-Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, gastrointestinal, hepatic, or renal disorder.
- •-Unwillingness or inability to comply with the study protocol for any other reason.
研究者
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