Gastric Emptying of Plant Sterol-containing Mini Drinks in Different Meal Intake Scenarios and Their Effect on Gallbladder Emptying
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 18
- 试验地点
- 1
- 主要终点
- GB volume measurement by ultrasonography
研究概览
简要总结
Background of the study:
Plant sterols can play an important role in lowering plasma cholesterol. The extent to which plant sterols can reduce plasma cholesterol levels depends on the intake scenario. We suggest that the difference in these effects depends on gastric emptying and bile secretion.
Objective of the study:
The aim of this study is to gain insight in the mechanisms that may be involved in the effects of plant sterol drinks on gastric emptying and gallbladder motility. In order to test this, we compare the different effects of the consumption of a plant sterol containing drink prior to, during and after a standardized meal.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Single Group
- 主要目的
- Basic Science
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- Male
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form
- •Sex: male
- •Age: 18-55 years
- •Body Mass Index (BMI): 20-25 kg/m2
排除标准
- •History of severe cardiovascular, respiratory, urogenital, gastrointestinal/ hepatic, hematological/immunologic, HEENT (head, ears, eyes, nose, throat), dermatological/connective tissue, musculoskeletal, metabolic/nutritional, endocrine, neurological/psychiatric diseases, allergy, major surgery which might limit participation in or completion of the study protocol.
- •Use of any medication on regular basis.
- •Use of paracetamol prior to treatment (≤ 48 hour).
- •Use of plant sterol/stanol enriched products or supplements 3 months prior to the study.
- •Blood donations less than three months previous to study enrolment.
- •Known hypersensitivity or allergy towards paracetamol.
- •Hyperlipidaemia (TG > 3 mmol/L and/or tot. chol. > 8 mmol/L)
- •Corn products prior to treatment (≤ 48 hour)
- •Presence of gallbladder stones.
- •Known allergy for cow milk and/or lactose intolerance
研究组 & 干预措施
Dietary Supplement: Plant sterol containing drink
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
干预措施: Plant sterol containing drink (Dietary Supplement)
Dietary Supplement: Plant sterol containing drink
The test products used in the study will be a commercially available PS drink and a ready to eat macaroni meal
干预措施: Standard macaroni meal (Dietary Supplement)
结局指标
主要结局
GB volume measurement by ultrasonography
时间窗: September 2009
次要结局
- GE rate measurement by 13C stable isotope breath test and plasma paracetamol concentration by clinical chemistry analysis(December 2009)