Oro-gastro-intestinal Digestion of Emulsified Fat and How This Digestion Relates to Colloidal Stability and Physiological Responses
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 15
- 试验地点
- 1
- 主要终点
- Appearance of free fatty acids in the duodenum
研究概览
简要总结
Interaction of fat with the mouth, stomach and intestine will trigger physiological responses that will impact on the digestion, gut transit time and absorption of fat. These responses will also influence and contribute to regulation of food intake and satiety. No systematic research on understanding how the physiological-chemical properties of food affect the digestion and absorption of lipids has been carried out previously. Studies have shown that the release of free fatty acids triggers the fat-related responses. The investigators hypothesize that the release of fatty acids depends on the colloidal state of the fat, which changes progressively due to the pH changes and enzyme activities in the mouth, stomach and intestine.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Treatment
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Signed informed consent form
- •Sex: male or female
- •Age: 18-55 years
- •Body Mass Index (BMI): 18-29 kg/m2
- •Based on medical history and previous examination, no gastrointestinal complaints can be defined.
排除标准
- •Evidence 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 and/or laboratory assessments which might limit participation in or completion of the study protocol
- •Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit
- •Use of psychotropic drugs, including: benzodiazepines. Concomitant medication that can increase gastric pH (e.g. antacids, proton pump inhibitors, prostaglandins, anticholinergic agents, H2-receptor antagonists), or alter gastric emptying (e.g. metoclopramide, cisapride, domperidone and erythromycin, anticholinergics, tricyclic antidepressants, narcotic analgetics, adrenergic agents, calcium channel blockers), or alter intestinal transit (e.g., loperamide, chemical/osmotic/bulk laxatives) or influence satiety/energy intake (e.g. sibutramine, glucocorticoids, anabolic steroids), except oral contraceptives
- •Pregnancy, lactation, wish to become pregnant during study, or having a positive pregnancy test at inclusion
- •Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment
- •Score > 9 on Factor 1 (dietary restrained) of the Dutch translation of the Three Factor eating Questionnaire (TFEQ) [17]
- •Blood donations less than three months previous to study enrollment, and for three months following participation
- •One or more of the following dietary habits: medically prescribed diets, weight reduction diets, or vegetarian/macrobiotic/biologically dynamic food habits. Administration of investigational drugs in the 180 days prior to the study
- •Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
- •Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, biological dynamic)
- •Excessive alcohol consumption (>20 alcoholic consumptions per week)
- •Self-admitted HIV-positive state
研究组 & 干预措施
emulsified fat, orally
At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80
干预措施: administration of fat (sunflower oil), emulsified (Dietary Supplement)
emulsified fat, orally
At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80
干预措施: Insertion of nasoduodenal tube (Procedure)
intragastric administration of fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically
干预措施: administration of fat (sunflower oil), emulsified (Dietary Supplement)
intragastric administration of fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically
干预措施: Insertion of nasoduodenal tube (Procedure)
intraduodenal administration of fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally
干预措施: administration of fat (sunflower oil), emulsified (Dietary Supplement)
intraduodenal administration of fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally
干预措施: Insertion of nasoduodenal tube (Procedure)
intragastric, non-emulsified fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically
干预措施: administration of fat (sunflower oil), emulsified (Dietary Supplement)
intragastric, non-emulsified fat
At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically
干预措施: Insertion of nasoduodenal tube (Procedure)
结局指标
主要结局
Appearance of free fatty acids in the duodenum
时间窗: In the first 180 min after administration of test product
The appearance of free fatty acids in the duodenum will be assessed during the 180 min following ingestion of the test product.
次要结局
- Colloidal stability of fat(In the first 180 min after administration of test product)