Clinical trial NCT02759926: The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake
Official title: The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Healthy
Obesity
Keywords: Healthy volunteers
Obesity
Bitter
Lead sponsor: Universitaire Ziekenhuizen KU Leuven
Sponsor class: OTHER
First posted: 2016-05-03
Enrollment: 98
Sex: ALL
Minimum age (years): 18
Maximum age (years): 60
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

Brief 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, 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.


Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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

Primary outcomes:
measure: Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
timeFrame: 2 hours after administration, continuous measurement with high resolution manometry
Secondary outcomes:
measure: Change in gut hormone release measured by specific radioactive immunoassays
timeFrame: 2 hours after administration, blood sample every 10 min
measure: Change in food intake measured by the caloric content of the meal
timeFrame: ad libitum food intake for 1 hour, 40 min after administration
measure: Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm
timeFrame: 2 hours after administration, assessment every 5 min
Other outcomes:
Locations:
Study officials:
affiliation: Universitaire Ziekenhuizen KU Leuven
name: Jan Tack, Prof
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.