ObesityNCT03140930
The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake
A study testing Tastants duodenal and Tastants ileal in people with Obesity, run by Maastricht University Medical Center at 1 site in Netherlands.
Trial summary
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- Tastants duodenal and Tastants ileal
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 19 participants
- Where
- 1 siteNetherlands
- Study dates
- 12 May 2017to 31 May 2018
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months
Who cannot join
- History 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. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), 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)
- Dieting (medically prescribed, vegetarian, diabetic, microbiological, biological dynamic)
- Pregnancy, lactation
Show all 11Show fewer
- Excessive alcohol consumption (>20 alcoholic consumptions per week)
- Smoking
- Weight <60kg
- Non-tasters of sweet, bitter or umami
- Evidence of MSG-hypersensitivity or Chinese restaurant syndrome
Trial locations and contacts
1 site in 1 country.
Netherlands1 site
Maastricht University Medical Center
Maastricht, Limburg, 6229HX
About this study
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The effects of intraduodenal and/or intraileal infusion of a combination of tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be investigated.
Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake.
Read more
Secondary objectives:
- To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.
- Conditions
- Obesity
- Being tested
- Tastants duodenal, Tastants ileal, Placebo duodenal, Placebo ileal
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tastants duodenalDietary supplement
Duodenal infusion of combination of tastants (sweet, bitter and umami)
Tastants ilealDietary supplement
Ileal infusion of combination of tastants (sweet, bitter and umami)
Placebo duodenalDietary supplement
Duodenal infusion of placebo (tap water)
Placebo ilealDietary supplement
Ileal infusion of placebo (tap water)
| Study group | Role | What they receive |
|---|---|---|
| Duodenal tastants, ileal placebo | Experimental | Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water) Receives: Dietary Supplement: Tastants duodenal; Dietary Supplement: Placebo ileal |
| Duodenal placebo, ileal tastants | Experimental | Duodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami) Receives: Dietary Supplement: Tastants ileal; Dietary Supplement: Placebo duodenal |
| Duodenal tastants, ileal tastants | Experimental | Duodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of combination of tastants (sweet, bitter and umami) Receives: Dietary Supplement: Tastants duodenal; Dietary Supplement: Tastants ileal |
| Duodenal placebo, ileal placebo | Placebo comparator | Duodenal infusion of placebo (tap water), ileal infusion of placebo (tap water) Receives: Dietary Supplement: Placebo duodenal; Dietary Supplement: Placebo ileal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Ad libitum meal intake
Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.
Measured: 5 weeks
Secondary outcomes (2)
Satiation
Difference in satiation (as measured by VAS) per time point.
Measured: 5 weeks
GI-symptoms
Difference in gastro-intestinal symptoms (as measured by VAS) per time point.
Measured: 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 May 2017
- Study start12 May 2017
- Primary completion31 May 2018
- Study completion31 May 2018
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
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 19 participants (actual)
Sponsor and investigators
- Lead sponsor
- Maastricht University Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Tim Klaassen, Maastricht University Medical Center
- Investigators
- Ad AM Masclee, Prof., Principal investigator, Maastricht University Medical Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03140930
- Sponsor's protocol ID
- NL59530.068.16
- Status last verified
- Nov 2019
- First submitted
- 2 May 2017
- Last updated
- 15 Nov 2019
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 15 Nov 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Duodenal, Ileal or Combined Infusion of Tastants on Food Intake
- ClinicalTrials.gov ID
- NCT03140930
- Acronym / sponsor ID
- NL59530.068.16
- Conditions
- Obesity
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 19 participants (actual)
- Lead sponsor
- Maastricht University Medical CenterUniversity, hospital or other
- Study start
- 12 May 2017 (actual)
- Primary completion
- 31 May 2018 (actual)
- Study completion
- 31 May 2018 (actual)
- First posted
- 4 May 2017 (actual)
- 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.
Rationale: The appearance of tastants in the small intestine can result in the activation of a negative feedback mechanism from different parts of the intestine to the stomach, the small intestine and to the central nervous system. These processes inhibit food processing, appetite sensations and food intake, and furthermore they increase feelings of satiety and satiation. The effects of intraduodenal and/or intraileal infusion of a combination of tastants (sweet (rebaudioside A), bitter (quinine) en umami (monosodium glutamate(MSG))) and placebo on ad libitum food intake, satiation and gastrointestinal symptoms will be investigated.
Objective: To investigate the effect of intraduodenal, intraileal and combined infusion of a combination of tastants versus infusion of placebo on food intake.
Secondary objectives:
- To compare the effect of intraduodenal versus intraileal versus combined intraduodenal and intraileal delivery of a combination of tastants on satiation.
- To assess the effect of intraduodenal and/or intraileal delivery of a combination of tastants on gastrointestinal symptoms/complaints.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Duodenal tastants, ileal placebo | Experimental | Dietary Supplement: Tastants duodenal, Dietary Supplement: Placebo ilealDuodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of placebo (tap water) |
| Duodenal placebo, ileal tastants | Experimental | Dietary Supplement: Tastants ileal, Dietary Supplement: Placebo duodenalDuodenal infusion of placebo (tap water), ileal infusion of combination of tastants (sweet, bitter and umami) |
| Duodenal tastants, ileal tastants | Experimental | Dietary Supplement: Tastants duodenal, Dietary Supplement: Tastants ilealDuodenal infusion of combination of tastants (sweet, bitter and umami), ileal infusion of combination of tastants (sweet, bitter and umami) |
| Duodenal placebo, ileal placebo | Placebo comparator | Dietary Supplement: Placebo duodenal, Dietary Supplement: Placebo ilealDuodenal infusion of placebo (tap water), ileal infusion of placebo (tap water) |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Based on medical history and previous examination, no gastrointestinal complaints can be defined.
- Age between 18 and 65 years. This study will include healthy adult subjects (male and female). Women must be taking contraceptives.
- BMI between 18 and 25 kg/m2)
- Weight stable over at least the last 6 months
Key exclusion criteria (11 listed)
- History 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. The severity of the disease (major interference with the execution of the experiment or potential influence on the study outcomes) will be decided by the principal investigator.
- Use of medication, including vitamin supplementation, except oral contraceptives, within 14 days prior to testing
- Administration of investigational drugs or participation in any scientific intervention study which may interfere with this study (to be decided by the principle investigator), 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)
- Dieting (medically prescribed, vegetarian, diabetic, microbiological, biological dynamic)
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 |
|---|---|---|
| Tastants duodenalDuodenal infusion of combination of tastants (sweet, bitter and umami) | Dietary supplement | Duodenal tastants, ileal placebo, Duodenal tastants, ileal tastants |
| Tastants ilealIleal infusion of combination of tastants (sweet, bitter and umami) | Dietary supplement | Duodenal placebo, ileal tastants, Duodenal tastants, ileal tastants |
| Placebo duodenalDuodenal infusion of placebo (tap water) | Dietary supplement | Duodenal placebo, ileal placebo, Duodenal placebo, ileal tastants |
| Placebo ilealIleal infusion of placebo (tap water) | Dietary supplement | Duodenal placebo, ileal placebo, Duodenal tastants, ileal placebo |
Primary outcome
Ad libitum meal intake
Time frame: 5 weeks
Difference in ad libitum meal intake (as measured during ad libitum pasta meal) at end of the test day.
2 secondary outcomes
Satiation
Time frame: 5 weeks
GI-symptoms
Time frame: 5 weeks
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 15 Nov 2019.
- Individual participant dataSharing planned: No
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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.
Ad AM Masclee, Prof. principal investigator
Maastricht University Medical Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Tastants duodenal and Tastants ileal 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 4 inclusion and 11 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 15 Nov 2019. 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. Some participants in this study may receive a placebo. 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?
Ad libitum meal intake (time frame: 5 weeks). 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 15 Nov 2019.