The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake

Not Applicable

• Conditions: Obesity; Healthy
• Interventions: Drug: Tap water; Drug: Quinine hydrochloride; Drug: Denatonium benzoate

• Registration Number: NCT02759926
• Lead Sponsor: Universitaire Ziekenhuizen KU Leuven

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-08
• Primary Completion: 2015-11
• Status Verified: 2016-04
• Study First Submitted: 2016-04-25
• Study First Submitted QC: 2016-04-29
• Last Update Submitted: 2016-04-29
• Study First Posted: 2016-05-03
• Last Update Posted: 2016-05-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 98

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Tap water intraduodenal	Tap water	An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
Quinine hydrochloride intragastric	Quinine hydrochloride	10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
Tap water intragastric	Tap water	An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.
Denatonium benzoate intragastric	Denatonium benzoate	1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
Quinine hydrochloride intraduodenal	Quinine hydrochloride	10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
Denatonium benzoate intraduodenal	Denatonium benzoate	1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Primary Outcome Measures

Name	Time	Method
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry	2 hours after administration, continuous measurement with high resolution manometry

Secondary Outcome Measures

Name	Time	Method
Change in gut hormone release measured by specific radioactive immunoassays	2 hours after administration, blood sample every 10 min
Change in food intake measured by the caloric content of the meal	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	2 hours after administration, assessment every 5 min