ObesityNCT01478750
Oro-gastro-intestinal Digestion of Emulsified Fat
A study testing administration of fat (sunflower oil), emulsified and Insertion of nasoduodenal tube in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
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. Read more about this study
- Who is it for?
- Ages 18 to 55 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- administration of fat (sunflower oil), emulsified and Insertion of nasoduodenal tube
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 15 participants
- Where
- 1 siteNetherlands
- Study dates
- Dec 2009to Jun 2011
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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]
Show all 13Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Centre
Maastricht, NL-6200MD
About this study
Official title: 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.
- Conditions
- Obesity
- Being tested
- administration of fat (sunflower oil), emulsified, Insertion of nasoduodenal tube
- Keywords
- obesity, fat, appetite, digestion
- Medical subject headings
- Obesity, Platelet Glycoprotein IV Deficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of fat (sunflower oil), emulsifiedDietary supplement
40 ml sunflower oil, in the presence of the emulsifier tween-80.
Insertion of nasoduodenal tubeProcedure or surgery
Also called nasoduodenal intubation, nasoduodenal catheter
A nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat
| Study group | Role | What they receive |
|---|---|---|
| emulsified fat, orally | Experimental | At 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 Receives: Dietary Supplement: administration of fat (sunflower oil), emulsified; Procedure: Insertion of nasoduodenal tube |
| intragastric administration of fat | Experimental | At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically Receives: Dietary Supplement: administration of fat (sunflower oil), emulsified; Procedure: Insertion of nasoduodenal tube |
| intraduodenal administration of fat | Experimental | At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally Receives: Dietary Supplement: administration of fat (sunflower oil), emulsified; Procedure: Insertion of nasoduodenal tube |
| intragastric, non-emulsified fat | Experimental | At 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically Receives: Dietary Supplement: administration of fat (sunflower oil), emulsified; Procedure: Insertion of nasoduodenal tube |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: In the first 180 min after administration of test product
Secondary outcomes (1)
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.
Measured: In the first 180 min after administration of test product
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Nov 2011 (estimated)
- Study startDec 2009
- Primary completionMay 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Maastricht University Medical CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Responsible party
- Sponsor
- Investigators
- Freddy Troost, PhD, Principal investigator, Maastricht University Medical Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01478750
- Sponsor's protocol ID
- NL27994.068.09
- Status last verified
- Oct 2012
- First submitted
- 14 Nov 2011
- Last updated
- 25 Oct 2012
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oro-gastro-intestinal Digestion of Emulsified Fat and How This Digestion Relates to Colloidal Stability and Physiological Responses
- ClinicalTrials.gov ID
- NCT01478750
- Acronym / sponsor ID
- NL27994.068.09
- Conditions
- Obesity
- Keywords
- obesity, fat, appetite, digestion
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Collaborators
- Top Institute Food and Nutrition
- Study start
- Dec 2009
- Primary completion
- May 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 23 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| emulsified fat, orally | Experimental | Dietary Supplement: administration of fat (sunflower oil), emulsified, Procedure: Insertion of nasoduodenal tubeAt 09:00, subjects will ingest the test load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 |
| intragastric administration of fat | Experimental | Dietary Supplement: administration of fat (sunflower oil), emulsified, Procedure: Insertion of nasoduodenal tubeAt 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intragastrically |
| intraduodenal administration of fat | Experimental | Dietary Supplement: administration of fat (sunflower oil), emulsified, Procedure: Insertion of nasoduodenal tubeAt 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, well emulsified with Tween-80 intraduodenally |
| intragastric, non-emulsified fat | Experimental | Dietary Supplement: administration of fat (sunflower oil), emulsified, Procedure: Insertion of nasoduodenal tubeAt 09:00, subjects will receive the load, consisting of 460 water and 40 ml sunflower oil, non emulsified, intragastrically |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (13 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| administration of fat (sunflower oil), emulsified40 ml sunflower oil, in the presence of the emulsifier tween-80. | Dietary supplement | emulsified fat, orally, intraduodenal administration of fat, intragastric administration of fat, intragastric, non-emulsified fat |
| Insertion of nasoduodenal tubeAlso: nasoduodenal intubation, nasoduodenal catheterA nasoduodenal tube is inserted to enable collection of gastric and duodenal aspirates of 2 mL each, to determine gastrointestinal digestion of fat | Procedure or surgery | emulsified fat, orally, intraduodenal administration of fat, intragastric administration of fat, intragastric, non-emulsified fat |
Primary outcome
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.
1 secondary outcome
Colloidal stability of fat
Time frame: In the first 180 min after administration of test product
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Oct 2012.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Freddy Troost, PhD principal investigator
Maastricht University Medical Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of fat (sunflower oil), emulsified and Insertion of nasoduodenal tube in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Oct 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Netherlands. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Appearance of free fatty acids in the duodenum (time frame: In the first 180 min after administration of test product). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Oct 2012.