NL-OMON33095已完成不适用
The effect of moderate alcohol consumption on a human in vivo model of low-grade systemic inflammation in young, normal-weight men - Effect of alcohol consumption on a markers of inflammation
Stichting Alcohol Research0 个研究点目标入组 24 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
- 已完成
- 发起方
- 入组人数
- 24
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
- 年龄范围
- 18 至 99（—）
入选标准
- •1. Healthy as assessed by the health and lifestyle questionnaire (P8600 F02), physical examination and results of the pre-study laboratory tests
- •2. Caucasian males aged 21-40 years at Day 01 of the study.
- •3. Body Mass Index (BMI) of 18 - 27 kg/m2.
- •4. Alcohol consumption >= 5 and <= 28 standard units/week.
- •5. Normal Dutch eating habits as assessed by P8600 F02.
- •6. Voluntary participation.
- •7. Having given written informed consent.
- •8. Willing to comply with the study procedures, including refrain from drinking alcoholic drinks other then the alcoholic beverage provided by TNO during the entire study and refrain from fermented dairy and probiotics-containing products.
- •9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years.
- •10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.
排除标准
- •Subjects with one or more of the following characteristics will be excluded from participation:
- •1. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study.
- •2. Participation in any non-invasive clinical trial up to 30 days before Day 01 of this study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances.
- •3. Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly metabolic or endocrine disease and gastrointestinal disorders.
- •4. Use of medication that may affect the outcome of the study parameters.
- •5. Having a family history of alcoholism.
- •6. Smoking.
- •7. Not having appropriate veins for blood sampling/cannula insertion according to TNO.
- •8. Reported unexplained weight loss or gain in the month prior to the pre-study screening.
- •9. Reported slimming or medically prescribed diet.
- •10. Reported vegan, vegetarian or macrobiotic.
- •11. Recent blood donation (<1 month prior to the start of the study).
- •12. Not willing to give up blood donation during the study.
- •13. Personnel of TNO Quality of Life, their partner and their first and second degree relatives.
- •14. Not having a general practitioner.
- •15. Not willing to accept information transfer which concerns participation in the study, or information regarding health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
- •16. Not willing your general practitioner to be notified upon participation in this study
研究者
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