Oro-gastro-intestinal Digestion of Emulsified Fat

Maastricht University Medical Centre (MUMC)

Status: Completed

Conditions: Obesity

Treatments: Procedure: Insertion of nasoduodenal tube; Dietary Supplement: administration of fat (sunflower oil), emulsified

Study type: Interventional

Funder types: Other

Identifiers

NCT01478750

NL27994.068.09

Details and patient eligibility

About

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.

Enrollment: 15 patients

Sex: All

Ages: 18 to 55 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Signed informed consent form
2. Sex: male or female
3. Age: 18-55 years
4. Body Mass Index (BMI): 18-29 kg/m2
5. Based on medical history and previous examination, no gastrointestinal complaints can be defined.

Exclusion criteria

1. 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
2. Gastrointestinal or hepatic disorders influencing gastrointestinal absorption or transit
3. 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
4. Pregnancy, lactation, wish to become pregnant during study, or having a positive pregnancy test at inclusion
5. Reported unexplained weight loss/gain of more than 2 kg in the month before the study enrollment
6. Score > 9 on Factor 1 (dietary restrained) of the Dutch translation of the Three Factor eating Questionnaire (TFEQ) [17]
7. Blood donations less than three months previous to study enrollment, and for three months following participation
8. 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
9. Major abdominal surgery interfering with gastrointestinal function (uncomplicated appendectomy, cholecystectomy and hysterectomy allowed, and other surgery upon judgement of the principle investigator)
10. Premenstrual syndrome, dieting (medically prescribed, vegetarian, diabetic, biological dynamic)
11. Excessive alcohol consumption (>20 alcoholic consumptions per week)
12. Smoking
13. Self-admitted HIV-positive state

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

15 participants in 4 patient groups

emulsified fat, orally

Experimental group

Description:

At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80

Treatment:

Dietary Supplement: administration of fat (sunflower oil), emulsified

Procedure: Insertion of nasoduodenal tube

intragastric administration of fat

Experimental group

Description:

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically

Treatment:

Dietary Supplement: administration of fat (sunflower oil), emulsified

Procedure: Insertion of nasoduodenal tube

intraduodenal administration of fat

Experimental group

Description:

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally

Treatment:

Dietary Supplement: administration of fat (sunflower oil), emulsified

Procedure: Insertion of nasoduodenal tube

intragastric, non-emulsified fat

Experimental group

Description:

At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically

Treatment:

Dietary Supplement: administration of fat (sunflower oil), emulsified

Procedure: Insertion of nasoduodenal tube