Oro-gastro-intestinal Digestion of Emulsified Fat

Obesity Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01478750
• Other study ID #: NL27994.068.09
• Status: Completed
• Phase: N/A
• First received: November 14, 2011
• Last updated: October 24, 2012
• Start date: December 2009
• Est. completion date: June 2011

Study information

• Verified date: October 2012
• Source: Maastricht University Medical Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)
• Study type: Interventional

Clinical Trial Summary

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: June 2011
• Est. primary completion date: May 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years to 55 Years

Eligibility

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

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Single Blind (Subject), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Obesity

Intervention

Dietary Supplement:
• administration of fat (sunflower oil), emulsified
40 ml sunflower oil, in the presence of the emulsifier tween-80.

Procedure:
• Insertion of nasoduodenal tube
A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat

Locations

Country	Name	City	State
Netherlands	Maastricht University Medical Centre	Maastricht

Sponsors (2)

Lead Sponsor	Collaborator
Maastricht University Medical Center	Top Institute Food and Nutrition

Country where clinical trial is conducted

Netherlands, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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	No