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Completed

NCT Number: NCT01478750

Oro-gastro-intestinal Digestion of Emulsified Fat

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.

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Platelet Glycoprotein IV Deficiency Signs and Symptoms

Age range

18 year–55 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Maastricht University Medical Centre

Maastricht, NL-6200MD, Netherlands

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

administration of fat (sunflower oil), emulsified

Dietary Supplement

40 ml sunflower oil, in the presence of the emulsifier tween-80.

Insertion of nasoduodenal tube

Procedure

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

Primary outcomes

  1. Appearance of free fatty acids in the duodenum

    Time frame: In the first 180 min after administration of test product

    The appearance of free fatty acids in the duodenum will be assessed during the 180 min following ingestion of the test product.

Secondary outcomes

  1. Colloidal stability of fat

    Time frame: In the first 180 min after administration of test product

    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.

Sponsors and collaborators

Lead sponsor

Maastricht University Medical Center

Other

Collaborators

  • Top Institute Food and Nutrition

Registry information

Official study title

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

Important dates

Study start
2009
Primary completion
2011
Study completion
2011
First posted
Nov 23, 2011
Registry last updated
Oct 25, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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