NL-OMON35155已完成不适用
A double-blind, randomized, placebo-controlled, crossover study on the effect of a dietary oil composition on food intake - Effect of a dietary oil composition on food intake
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
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 TNO health & lifestyle questionnaire and limited physical examination
- •2. Male or female, age * 18 and * 30 years at Day 01 of the study
- •3. Body Mass Index (BMI) * 20 and * 27 kg/m2
- •4. Normal Dutch eating habits; consuming mostly three main meals per day
- •5. Non restrained eater, defined as the following scores on cognitive restraint according to the Dutch Eating Behaviour Questionnaire: men with a DEBQ-restraint score of <=2.37; women (BMI <26 kg/m2) DEBQ-restraint score <=3.24; women (BMI >=26 kg/m2) DEBQ-restraint score <=3.41)
- •6. Voluntary participation
- •7. Having given their written informed consent
- •8. Willing to comply with the study procedures
- •9. Willing to accept use of all nameless data, including publication, and the confidential use and storage of all data for at least 15 years
- •10. Willing to accept the disclosure of the financial benefit of participation in the study to the authorities concerned
排除标准
- •1.Having a history of medical or surgical events that may significantly affect the study outcome, including metabolic or endocrine disorders, gastro-intestinal disorders, eating behaviour disorders.
- •2. Any prescribed medication with the exception of incidental use of pain killers and use of (oral) contraceptives
- •3. Intolerance or allergy to milk products
- •4. Alcohol consumption > 28 units/week for males or > 21 units/week for females
- •5. Smoking
- •6. Coffee consumption of > 8 cups/day
- •7. Reported unexplained weight loss or weight gain of > 2 kg in the 2 months prior to start of the study
- •8. Reported slimming or medically prescribed diet
- •9. Reported vegan, vegetarian or macrobiotic diet
- •10. Pregnant or lactating or wishing to became pregnant during the study period
- •11. Participation in any clinical trial including blood sampling and/or administration of substances up to 30 days before Day 01 of this study.
- •12. Participation in any clinical trial including blood sampling and/or administration of substances during the conduct of this study.
- •13. Personnel of TNO, location Zeist, their partner and their first and second degree relatives
- •14. Not having a general practitioner
- •15. Not willing that one*s physician will be informed about participation in this study
- •16. Not willing to accept information-transfer concerning information regarding a subject*s health (laboratory results, findings at anamnesis or physical examination and eventual adverse events) to and from a subject*s general practitioner.
研究者
相似试验
进行中(未招募)
1 期
A study to evaluate the clinical efficacy and safety of subcutaneously administered C1-esterase inhibitor in the prevention of hereditary angioedema.EUCTR2013-000916-10-CZCSL Behring GmbH80
进行中(未招募)
不适用
A study to evaluate the clinical efficacy and safety of subcutaneously administered C1-esterase inhibitor in the prevention of hereditary angioedema.Hereditary Angioedema (HAE) type I and IIMedDRA version: 16.0Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-000916-10-ITCSL Behring GmbH100
进行中(未招募)
不适用
A study to evaluate the clinical efficacy and safety of subcutaneously administered C1-esterase inhibitor in the prevention of hereditary angioedema.Hereditary Angioedema (HAE) type I and IIMedDRA version: 17.0Level: PTClassification code 10019860Term: Hereditary angioedemaSystem Organ Class: 10010331 - Congenital, familial and genetic disordersEUCTR2013-000916-10-HUCSL Behring GmbH80
进行中(未招募)
1 期
A study to evaluate the clinical efficacy and safety of subcutaneously administered C1-esterase inhibitor in the prevention of hereditary angioedema.EUCTR2013-000916-10-GBCSL Behring GmbH80
进行中(未招募)
不适用
A double-blind, randomized, placebo-controlled, cross-over study to evaluate the safety, tolerability and preliminary efficacy of alginate oligosaccharide (OligoG) administered for 28 days in subjects with Cystic Fibrosis chronically colonised with Pseudomonas aeruginosaMedDRA version: 14.1Level: PTClassification code 10011762Term: Cystic fibrosisSystem Organ Class: 10010331 - Congenital, familial and genetic disordersCystic FibrosisEUCTR2010-023090-19-IEAlgiPharma AS24
