NL-OMON31093已完成不适用
Effect of moderate alcohol consumption on postprandial insulin secretion, appetite regulation, glucose homeostasis and insulin resistance. - Effect of moderate alcohol consumption on postprandial insulin secretion
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 (P7573 F02; in Dutch), physical examination and results of the pre-study laboratory tests
- •2. Females between 20 - 44 years of age at day of inclusion
- •3. Using oral contraceptives for >3 months (only phase 1 or 2 oral contraceptives)
- •4. Normal fasting glucose levels as indicated by venous fasting plasma glucose levels < 6.1 mmol/L
- •5. Used to drink beer
- •6. Alcohol consumption more or equal than 5 and less than 22 glasses/week
- •7. Body Mass Index (BMI) between 20 and 25 kg/m2
- •8. Normal Dutch eating habits as assessed by the questionnaire P7573 F02 on health and lifestyle
- •9. Appropriate veins for blood sampling and cannula insertion
- •10. Voluntary participation
- •11. Having given their written informed consent
- •12. Willing to comply with the study procedures
- •13. Willing not to serve as blood donor during the study
- •14. Non restraint eater, defined as a score of < 3.25 in non obese subjects on the Dutch Eating Behaviour Questionnaire
- •15. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
排除标准
- •1. Having the intention to become pregnant, to be pregnant or to lactate during the study
- •2. Participation in any clinical trial including blood sampling and/or administration of substances up to 90 days before Day 01 of this study
- •3. Participation in any non-invasive clinical trial up to 30 days before day 01 of the study, including no blood sampling and/or oral, intravenous, inhalatory administration of substances
- •4. Having a history of medical or surgical events that may significantly affect the study outcome including metabolic or endocrine disease, gastro-intestinal disorder, or eating behavior disorders such as anorexia/bulimia disorders
- •5. Having a family history of alcoholism
- •6. Mental or physical status that is incompatible with the proper conduct of the study
- •7. Use of medication that may affect the outcome of the study parameters (except oral contaceptives)
- •8. Smoking
- •9. Reported use of any soft or hard drugs
- •10. Reported unexplained weight loss or gain of > 3 kg in the month prior to the screen¬ing
- •11. Reported slimming or medically prescribed diet
- •12. Reported vegetarian, vegan or macrobiotic
- •13. Recent blood donation (<1 month prior to the start of the study)
- •14. Not willing to give up blood donation during the study
- •16. Not having a general practitioner
- •17. 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 her general practitioner
- •18. Not willing your general practitioner to be notified upon participation in this study
研究者
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