ISRCTN10600261已完成不适用
A high-calorie challenge within the healthy range of the population
TNO0 个研究点目标入组 100 人开始时间: 2017年5月12日最近更新:
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
2017 results in: https://www.ncbi.nlm.nih.gov/pubmed/29225708
研究设计
- 研究类型
- Interventional
入排标准
- 性别
- Male
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 and the health and lifestyle questionnaire.
- •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
- •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 1
- •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 hypertension defined as 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
- •For the sub investigation (Raman spectroscopy):
- •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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