Oro-gastro-intestinal Digestion of Emulsified Fat

This study has been completed.
Sponsor:
Collaborator:
Top Institute Food and Nutrition
Information provided by (Responsible Party):
Maastricht University Medical Center
ClinicalTrials.gov Identifier:
NCT01478750
First received: November 14, 2011
Last updated: October 24, 2012
Last verified: October 2012
  Purpose

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.


Condition Intervention
Obesity
Dietary Supplement: administration of fat (sunflower oil), emulsified
Procedure: Insertion of nasoduodenal tube

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single Blind (Subject)
Primary Purpose: Treatment
Official Title: Oro-gastro-intestinal Digestion of Emulsified Fat and How This Digestion Relates to Colloidal Stability and Physiological Responses

Resource links provided by NLM:


Further study details as provided by Maastricht University Medical Center:

Primary Outcome Measures:
  • Appearance of free fatty acids in the duodenum [ Time Frame: In the first 180 min after administration of test product ] [ Designated as safety issue: No ]
    The appearance of free fatty acids in the duodenum will be assessed during the 180 min following ingestion of the test product.


Secondary Outcome Measures:
  • Colloidal stability of fat [ Time Frame: In the first 180 min after administration of test product ] [ Designated as safety issue: No ]
    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.


Enrollment: 15
Study Start Date: December 2009
Study Completion Date: June 2011
Primary Completion Date: May 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

  Eligibility

Ages Eligible for Study:   18 Years to 55 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01478750

Locations
Netherlands
Maastricht University Medical Centre
Maastricht, Netherlands, NL-6200MD
Sponsors and Collaborators
Maastricht University Medical Center
Top Institute Food and Nutrition
Investigators
Principal Investigator: Freddy Troost, PhD Maastricht University Medical Centre
  More Information

No publications provided

Responsible Party: Maastricht University Medical Center
ClinicalTrials.gov Identifier: NCT01478750     History of Changes
Other Study ID Numbers: NL27994.068.09
Study First Received: November 14, 2011
Last Updated: October 24, 2012
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht University Medical Center:
obesity
fat
appetite
digestion

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on July 24, 2014