NL-OMON40953已完成不适用
The influence of seafood enrichment on mental performance and anti-oxidant status - EnRichMar
Matis0 个研究点目标入组 150 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
- 150
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. Age 18-70 yr; preferably 35 - 70
- •2. BMI > 20 kg/m2 and < 40 kg/m2 (preferably 25 - 32 ) and waist circumference > 80 cm (women) or > 94 cm (men)
- •3. Healthy as assessed by the independent physician based on medical history and values of total cholesterol, CRP, triglycerides and glucose
- •4. Voluntary participation
- •5. Having given written informed consent
- •6. Willing to comply with the study procedures
- •7. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- •8. 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 or any non-invasive clinical trial up to 30 days before Day 01 of this study.
- •2. Having a history of medical or surgical events/ailments/treatments that may significantly affect the study outcome, including psychiatric disorders
- •3. Mental status that is incompatible with the proper conduct of the study
- •4. Known allergy or intolerance to food products, especially cereal, dairy and fish products
- •5. Use of dietary supplements
- •6. Smoking
- •7. Being colourblind
- •8. Alcohol consumption > 28 units/week for males and > 21 units/week for females
- •9. Reported slimming or medically prescribed diet
- •10. Personnel of CRO, their partner and their first and second degree relatives
- •11. Not having a general practitioner
- •12. Not willing to accept information-transfer concerning participation in the study, or information regarding his/her health, like laboratory results, findings at anamnesis or physical examination and eventual adverse events to and from his general practitioner.
- •13. Pregnant or lactating or wishing to become pregnant in the period of the study
- •14. Extreme physical activity (more than 6h/week)
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