NL-OMON35204已完成不适用
The effect of moderate alcohol consumption with a meal in different ambiances on postprandial mood, evaluated by subjective and objective responses. - Effect of moderate alcohol consumption on postprandial mood
Stichting Alcohol Research0 个研究点目标入组 28 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
- 28
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
- •9.4 Inclusion criteria
- •1. Healthy as assessed by the health and lifestyle questionnaire, (P9334 F02; in Dutch).
- •2. Females aged 18-45 years at Day 01 of the study*
- •3. Taking a monophasic combined oral contraceptive pill at Day 01 of the study, with 21 days of taking pills with active ingredients followed by 7 days taking no pills or continuous intake of the oral contraceptive pill**.
- •4. Body Mass Index (BMI) of 18.5-27 kg/m2 *
- •5. Body weight between 57 and 80 kg
- •6. Normal Dutch eating habits as assessed by P9334 F02
- •7. Alcohol consumption >= 3 and <= 21 standard units/week*
- •8. Voluntary participation
- •9. Having given written informed consent
- •10. Willing to comply with the study procedures, including refrain from alcohol 24 h before the test days and refrain from caffeine during the afternoon of the test day.
- •11. Appropriate veins for blood sampling/cannula insertion according to TNO
- •12. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- •13. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned.;* Volunteers within the age of 25-45 years, a BMI of 20-25 and with an alcohol consumption between 3-14 standard glasses/week are preferred for inclusion.
- •** With the recruitment letter, a list with accepted brands of oral contraceptive pills for participation will be added.
排除标准
- •9.5 Exclusion criteria
- •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. Having a history of medical or surgical events or disease that may significantly affect the study outcome, particularly physiological disorders, or psychiatric, metabolic or endocrine disease and gastrointestinal disorders.
- •3. Use of medication that may affect the outcome of the study parameters (e.g. antidepressive drugs).
- •4. Having a family history of alcoholism
- •5. Having a history of alcohol or drug related problems
- •6. Smoking
- •7. Reported unexplained weight loss or gain of > 2 kg in the month prior to the pre-study screening
- •8. Reported slimming or medically prescribed diet
- •9. Reported vegan, vegetarian or macrobiotic
- •10. Recent blood donation (<1 month prior to the start of the study)
- •11. Not willing to give up blood donation during the study.
- •12. Pregnant (to their own knowledge) or lactating or wishing to become pregnant in the period of the study
- •13. Personnel of TNO Zeist, their partner and their first and second degree relatives
- •14. Not having a general practitioner
- •15. Not willing to accept information-transfer concerning participation in the study, or information regarding her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
研究者
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