Oro-gastro-intestinal Digestion of Emulsified Fat

October 24, 2012 updated by: Maastricht University Medical Center

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

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

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

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
In the first 180 min after administration of test product

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
In the first 180 min after administration of test product

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Maastricht University Medical Center

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Top Institute Food and Nutrition

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Freddy Troost, PhD, Maastricht University Medical Centre

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
December 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2011

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 14, 2011

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 21, 2011

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 23, 2011

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
October 25, 2012

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 24, 2012

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
October 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • NL27994.068.09

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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