NL-OMON31240已完成2 期
The effect of body fat distribution on the physiological response to a dietary fat intervention. - Body fat distribution and fat metabolism
TNO0 个研究点目标入组 12 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 12
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, physical examination and results of the pre-study laboratory tests;
- •2. Males aged between 30 - 60 years at Day 01 of the study;
- •3. Overweight/obese subjects, Body Mass Index (BMI) between 27-35 kg/m2 ;
- •4. Range in waist-hip ratio as high as possible (preferably below 0.90 or above 0.95);
- •5. Regular Dutch eating habits as assessed by P7261 F02 and used to consume margarine;
- •6. Non restrained eater, defined as a score of <3.25 in obese men on the Dutch Restrained Eating Questionnaire;
- •7. Appropriate veins for blood sampling / cannula insertion according to TNO employees;
- •8. Voluntary participation;
- •9. Having given written informed consent;
- •10. Willing to comply with the study procedures (consumption of the fat supplements for three weeks and the last days testing at TNO);
- •11. Agree to be informed about chance findings of pathology found with the MRI;
- •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.
排除标准
- •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 that may significantly affect the study outcome, including any psychiatric history, and metabolic or endocrine disease, or any gastro-intestinal disorder;
- •4. Use of medication that may influence appetite, and/or sensory functioning within 14 days before day 01, except paracetamol;
- •5. Smoking;
- •6. Alcohol consumption (> 28 units/week);
- •7. Contra-indication to MRI scanning (claustrophobia; pacemakers and defibrillators; nerve stimulators; intracranial clips; intraorbital or intraocular metallic fragments; cochlear implants; ferromagnetic implants; presence of any other metal object e.g. in the mouth);
- •8. Reported unexplained weight loss or gain of > 2 kg 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 concerning participation in the study, or information regarding his 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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