Oro-gastro-intestinal Digestion of Emulsified Fat

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

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.

Study Overview

• Status: Completed
• Conditions: Obesity
• Intervention / Treatment: Dietary supplement: administration of fat (sunflower oil), emulsified; Procedure: Insertion of nasoduodenal tube

• Study Type: Interventional
• Enrollment (Actual): 15
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Netherlands
  • Maastricht, Netherlands, NL-6200MD
    • Maastricht University Medical Centre

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 55 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 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	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; Other Names: nasoduodenal intubation; nasoduodenal catheter
Experimental: 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	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; Other Names: nasoduodenal intubation; nasoduodenal catheter
Experimental: 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	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; Other Names: nasoduodenal intubation; nasoduodenal catheter
Experimental: intragastric, non-emulsified fat; 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; 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; Other Names: nasoduodenal intubation; nasoduodenal catheter

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Maastricht University Medical Center
• Collaborators: Top Institute Food and Nutrition
• Investigators: Principal Investigator: Freddy Troost, PhD, Maastricht University Medical Centre

Study record dates

Study Major Dates

• Study Start: December 1, 2009
• Primary Completion (Actual): May 1, 2011
• Study Completion (Actual): June 1, 2011

Study Registration Dates

• First Submitted: November 14, 2011
• First Submitted That Met QC Criteria: November 21, 2011
• First Posted (Estimate): November 23, 2011

Study Record Updates

• Last Update Posted (Estimate): October 25, 2012
• Last Update Submitted That Met QC Criteria: October 24, 2012
• Last Verified: October 1, 2012

More Information

Terms related to this study

• Keywords: obesity; appetite; fat; digestion
• Additional Relevant MeSH Terms: Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity
• Other Study ID Numbers: NL27994.068.09