HealthyNCT02759926
The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake
A study testing Denatonium benzoate, Quinine hydrochloride and Tap water in people with Healthy and Obesity, run by Universitaire Ziekenhuizen KU Leuven.
Trial summary
In this study, the investigators aimed at evaluating the role of bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity… Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- What is being tested?
- Denatonium benzoate, Quinine hydrochloride and Tap water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 98 participants
- Where
- No sites listed yet
- Study dates
- Aug 2011to Nov 2015
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI>30 kg/m² for the obese volunteers
- BMI<30 kg/m² for the lean volunteers
- Subject is capable and willing to give informed consent
- Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
Who cannot join
- Female volunteer is pregnant or breastfeeding
- Gastrointestinal diseases, major abdominal surgery
- Major psychiatric illnesses
- Volunteers that use drugs affecting the GIT or the central nervous system (CNS)
- Volunteers that suffer from diabetes mellitus
- Volunteers suffering from an endocrine disease such as diabetes, Cushing's disease, Addison's disease, hypothalamic tumor…
- Volunteers that have undergone surgical procedure for weight loss
About this study
Official title: The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
In this study, the investigators aimed at evaluating the role of bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.
- Being tested
- Denatonium benzoate, Quinine hydrochloride, Tap water
- Keywords
- Healthy volunteers, Obesity, Bitter
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Denatonium benzoateDrug
Quinine hydrochlorideDrug
Tap waterDrug
| Study group | Role | What they receive |
|---|---|---|
| Denatonium benzoate intragastric | Active comparator | 1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube. Receives: Drug: Denatonium benzoate |
| Quinine hydrochloride intragastric | Active comparator | 10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube. Receives: Drug: Quinine hydrochloride |
| Tap water intragastric | Placebo comparator | An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube. Receives: Drug: Tap water |
| Denatonium benzoate intraduodenal | Active comparator | 1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. Receives: Drug: Denatonium benzoate |
| Quinine hydrochloride intraduodenal | Active comparator | 10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. Receives: Drug: Quinine hydrochloride |
| Tap water intraduodenal | Placebo comparator | An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. Receives: Drug: Tap water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
Measured: 2 hours after administration, continuous measurement with high resolution manometry
Secondary outcomes (3)
Change in gut hormone release measured by specific radioactive immunoassays
Measured: 2 hours after administration, blood sample every 10 min
Change in food intake measured by the caloric content of the meal
Measured: ad libitum food intake for 1 hour, 40 min after administration
Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm
Measured: 2 hours after administration, assessment every 5 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 May 2016 (estimated)
- Study startAug 2011
- Primary completionNov 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for HealthyStudies of the same condition, open and under way.
- More trials run by Universitaire Ziekenhuizen KU LeuvenThe 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
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 98 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universitaire Ziekenhuizen KU Leuven
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Jan Tack, Prof, Principal investigator, Universitaire Ziekenhuizen KU Leuven
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02759926
- Sponsor's protocol ID
- BitterMotilityHungerFoodIntake
- Status last verified
- Apr 2016
- First submitted
- 25 Apr 2016
- Last updated
- 3 May 2016
- Results posted
- No
- Data monitoring committee
- No
Publications
Deloose E, Janssen P, Corsetti M, Biesiekierski J, Masuy I, Rotondo A, Van Oudenhove L, Depoortere I, Tack J. Intragastric infusion of denatonium benzoate attenuates interdigestive gastric motility and hunger scores in healthy female volunteers. Am J Clin Nutr. 2017 Mar;105(3):580-588. doi: 10.3945/ajcn.116.138297. Epub 2017 Feb 1.
PubMed 28148502
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
- ClinicalTrials.gov ID
- NCT02759926
- Acronym / sponsor ID
- BitterMotilityHungerFoodIntake
- Keywords
- Healthy volunteers, Obesity, Bitter
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 98 participants (estimated)
- Lead sponsor
- Universitaire Ziekenhuizen KU LeuvenUniversity, hospital or other
- Study start
- Aug 2011
- Primary completion
- Nov 2015 (actual)
- First posted
- 3 May 2016 (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.
In this study, the investigators aimed at evaluating the role of bitter taste receptors in the gastrointestinal tract (GIT). Intragastric or intraduodenal administration of denatonium benzoate (DB) or quinine hydrochloride were compared with placebo administration for their effects on lingual sensitivity, gastrointestinal motility (both in the fasted and fed state), gut hormone release (motilin, ghrelin, glucagon-like peptide-1 (GLP-1) and cholecystokinin (CCK)) and food intake. Differences between lean and obese subjects will be evaluated.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 6
| Arm | Type | Receives |
|---|---|---|
| Denatonium benzoate intragastric | Active comparator | Drug: Denatonium benzoate1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube. |
| Quinine hydrochloride intragastric | Active comparator | Drug: Quinine hydrochloride10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube. |
| Tap water intragastric | Placebo comparator | Drug: Tap waterAn equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube. |
| Denatonium benzoate intraduodenal | Active comparator | Drug: Denatonium benzoate1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. |
| Quinine hydrochloride intraduodenal | Active comparator | Drug: Quinine hydrochloride10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. |
| Tap water intraduodenal | Placebo comparator | Drug: Tap waterAn equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- BMI>30 kg/m² for the obese volunteers
- BMI<30 kg/m² for the lean volunteers
- Subject is capable and willing to give informed consent
- Female volunteers of child bearing potential must use oral, injected or implanted hormonal methods of contraception
Key exclusion criteria (7 listed)
- Female volunteer is pregnant or breastfeeding
- Gastrointestinal diseases, major abdominal surgery
- Major psychiatric illnesses
- Volunteers that use drugs affecting the GIT or the central nervous system (CNS)
- Volunteers that suffer from diabetes mellitus
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 |
|---|---|---|
| Denatonium benzoate | Drug | Denatonium benzoate intraduodenal, Denatonium benzoate intragastric |
| Quinine hydrochloride | Drug | Quinine hydrochloride intraduodenal, Quinine hydrochloride intragastric |
| Tap water | Drug | Tap water intraduodenal, Tap water intragastric |
Primary outcome
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
Time frame: 2 hours after administration, continuous measurement with high resolution manometry
3 secondary outcomes
Change in gut hormone release measured by specific radioactive immunoassays
Time frame: 2 hours after administration, blood sample every 10 min
Change in food intake measured by the caloric content of the meal
Time frame: ad libitum food intake for 1 hour, 40 min after administration
Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm
Time frame: 2 hours after administration, assessment every 5 min
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 May 2016.
- Derived from this study: PubMed 28148502Deloose E, Janssen P, Corsetti M, Biesiekierski J, Masuy I, Rotondo A, Van Oudenhove L, Depoortere I, Tack J. Intragastric infusion of denatonium benzoate attenuates interdigestive gastric motility and hunger scores in healthy female volunteers. Am J Clin Nutr. 2017 Mar;105(3):580-588. doi: 10.3945/ajcn.116.138297. Epub 2017 Feb 1.
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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.
Jan Tack, Prof principal investigator
Universitaire Ziekenhuizen KU Leuven
Questions about this trial
What is this clinical trial studying?
A study testing Denatonium benzoate, Quinine hydrochloride and Tap water in people with Healthy and Obesity, run by Universitaire Ziekenhuizen KU Leuven.
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 7 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: status not confirmed, as of the sponsor's last update on 3 May 2016. Status can change between updates, so confirm with the study contact before making plans.
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?
Results are not available in the source record.
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?
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry (time frame: 2 hours after administration, continuous measurement with high resolution manometry). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02759926, which also lists 1 linked publication.
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 3 May 2016.