NL-OMON38724已完成不适用
A high-calorie challenge within the healthy range of the population - A high-calorie challenge
TNO0 个研究点目标入组 100 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
- 100
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 male / female subjects (ratio: 50-50), 20 to 70 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history, a complete physical examination including vital signs, hematology and blood chemistry.
- •2. Body fat percentage within limits of predefined recruitment categories.
- •3. Able to participate and willing to give written informed consent and to comply with the study restrictions.
排除标准
- •1. Participation in an investigational drug or device study within 3 months prior to screening and / or participation of more than 4 times in the previous year.
- •2. Loss of blood outside the limits of Sanquin (500 mL) within 3 months prior to screening or not willing to refrain from blood- or plasma donation during the study.
- •3. Average alcohol consumption > 21 units/week for women and > 28 units/week for men.
- •4. Change of smoking habits within two months prior to screening.
- •5. Not having a general practitioner or health insurance.
- •6. Unacceptable concomitant medication use at baseline, e.g., drugs known or likely to interact with the challenge drink or study assessments
- •7. Use of dietary supplements less than one month prior to Day 01.
- •8. Reported slimming or being on a medically prescribed diet.
- •9. Reported unexplained weight loss or gain of > 2 kg in the last month before screening.
- •10. Reported food allergy or sensitivity for one of the used ingredients.
- •11. Females who are pregnant, planning to be pregnant during the study period, or lactating.
- •12. Not willing to accept information transfer which concerns participation in the study or information regarding health (e.g. laboratory results, findings at health and lifestyle questionnaire, physical examination or eventual adverse events) to and from their general practitioner.
- •13. Having a systolic blood pressure (SBP) greater than 140 mmHg or diastolic blood pressure (DBP) greater than 90 mmHg (assessed three times at five minutes interval). In the case of isolated systolic hypertension in middle aged volunteers (phenotypic group 5 and 10), the principal investigator will judge whether this condition will cause a clinically significant interference with the study outcome.
- •14. Clinically significant abnormalities, as judged by the Investigator, in laboratory test results. In the case of uncertain or questionable results, tests performed during screening may be repeated once before determination of eligibility.
- •15. Inappropriate veins for cannula insertion.
- •16. Having a chronic disease related to inflammation (such as arthritis).
- •17. Having a history or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
- •18. Any known factor, condition, or disease that might interfere with treatment compliance, study conduct or interpretation of the results such as drug or alcohol dependence or psychiatric disease.
- •19. Unwillingness or inability to comply with the study protocol for any other reason.;Additional exclusion criteria for the sub-investigation (Raman spectroscopie):
- •20. Dark skin color according to the Fitzpatrick skin type scale (type 5 or 6).
- •21. Abnormalities of the skin at the desired measurement location (upper side of forearm).
研究者
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