Oro-gastro-intestinal Digestion of Emulsified Fat

Study Overview
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Brief Summary
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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.

Official Title
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Oro-gastro-intestinal Digestion of Emulsified Fat and How This Digestion Relates to Colloidal Stability and Physiological Responses

Conditions
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Obesity

Intervention / Treatment
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* Dietary Supplement: administration of fat (sunflower oil), emulsified
* Procedure: Insertion of nasoduodenal tube


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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. Exclusion Criteria: 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) Smoking Self-admitted HIV-positive state

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 55 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: emulsified fat, orally<br>At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 | Dietary Supplement: administration of fat (sunflower oil), emulsified<br>* 40 ml sunflower oil, in the presence of the emulsifier tween-80.<br>Procedure: Insertion of nasoduodenal tube<br>* A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat<br>* Other names: nasoduodenal catheter;|
| Experimental: intragastric administration of fat<br>At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically | Dietary Supplement: administration of fat (sunflower oil), emulsified<br>* 40 ml sunflower oil, in the presence of the emulsifier tween-80.<br>Procedure: Insertion of nasoduodenal tube<br>* A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat<br>* Other names: nasoduodenal catheter;|
| Experimental: intraduodenal administration of fat<br>At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally | Dietary Supplement: administration of fat (sunflower oil), emulsified<br>* 40 ml sunflower oil, in the presence of the emulsifier tween-80.<br>Procedure: Insertion of nasoduodenal tube<br>* A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat<br>* Other names: nasoduodenal catheter;|
| Experimental: intragastric, non-emulsified fat<br>At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically | Dietary Supplement: administration of fat (sunflower oil), emulsified<br>* 40 ml sunflower oil, in the presence of the emulsifier tween-80.<br>Procedure: Insertion of nasoduodenal tube<br>* A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat<br>* Other names: nasoduodenal catheter;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Appearance of free fatty acids in the duodenum | The appearance of free fatty acids in the duodenum will be assessed during the 180 min following ingestion of the test product. | In the first 180 min after administration of test product | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Colloidal stability of fat | Droplet size, flocculation, aggregation, coalescence) in samples from the oral, gastric and duodenal compartment will be determined during the 180 min following ingestion of the test product. | In the first 180 min after administration of test product | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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fat, obesity, appetite, digestion