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

Sponsor

Universitaire Ziekenhuizen Leuven (Other)

Overall Status

Unknown status

CT.gov ID

NCT02759926

Collaborator

(none)

Enrollment

Arms

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Healthy Obesity	Drug: Denatonium benzoate Drug: Quinine hydrochloride Drug: Tap water	N/A

Study Design

Study Type:

Interventional

Anticipated Enrollment :

98 participants

Allocation:

Randomized

Intervention Model:

Crossover Assignment

Masking:

Single (Participant)

Primary Purpose:

Basic Science

Official Title:

The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility

Study Start Date :

Aug 1, 2011

Actual Primary Completion Date :

Nov 1, 2015

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

Change in gastrointestinal motility measured by antroduodenal high-resolution manometry [2 hours after administration, continuous measurement with high resolution manometry]

Secondary Outcome Measures

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]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 60 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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