Overview

This trial is active, not recruiting.

Conditions healthy, obesity
Treatments denatonium benzoate, quinine hydrochloride, tap water
Sponsor Universitaire Ziekenhuizen Leuven
Start date August 2011
End date November 2015
Trial size 98 participants
Trial identifier NCT02759926, BitterMotilityHungerFoodIntake

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking single blind (subject)
Primary purpose basic science
Arm
(Active Comparator)
1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
denatonium benzoate
(Active Comparator)
10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
quinine hydrochloride
(Placebo Comparator)
An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.
tap water
(Active Comparator)
1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
denatonium benzoate
(Active Comparator)
10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
quinine hydrochloride
(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.
tap water

Primary Outcomes

Measure
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
time frame: 2 hours after administration, continuous measurement with high resolution manometry

Secondary Outcomes

Measure
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

Eligibility Criteria

Male or female participants from 18 years up to 60 years old.

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

Additional Information

Official title The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
Principal investigator Jan Tack, Prof
Trial information was received from ClinicalTrials.gov and was last updated in April 2016.
Information provided to ClinicalTrials.gov by Universitaire Ziekenhuizen Leuven.