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

Universitaire Ziekenhuizen KU Leuven

Status: Unknown

Conditions: Healthy; Obesity

Treatments: Drug: Tap water; Drug: Denatonium benzoate; Drug: Quinine hydrochloride

Study type: Interventional

Funder types: Other

Identifiers

NCT02759926

BitterMotilityHungerFoodIntake

Details and patient eligibility

About

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.

Enrollment: 98 estimated patients

Sex: All

Ages: 18 to 60 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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98 participants in 6 patient groups, including a placebo group

Denatonium benzoate intragastric

Active Comparator group

Description:

1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.

Treatment:

Drug: Denatonium benzoate

Quinine hydrochloride intragastric

Active Comparator group

Description:

10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.

Treatment:

Drug: Quinine hydrochloride

Tap water intragastric

Placebo Comparator group

Description:

An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.

Treatment:

Drug: Tap water

Denatonium benzoate intraduodenal

Active Comparator group

Description:

1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Treatment:

Drug: Denatonium benzoate

Quinine hydrochloride intraduodenal

Active Comparator group

Description:

10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Treatment:

Drug: Quinine hydrochloride

Tap water intraduodenal

Placebo Comparator group

Description:

An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.

Treatment:

Drug: Tap water