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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

98 participants

Study Classification

INTERVENTIONAL

Study Start Date

2011-08-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Healthy Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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Denatonium benzoate intragastric

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

Group Type ACTIVE_COMPARATOR

Denatonium benzoate

Intervention Type DRUG

Quinine hydrochloride intragastric

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

Group Type ACTIVE_COMPARATOR

Quinine hydrochloride

Intervention Type DRUG

Tap water intragastric

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

Group Type PLACEBO_COMPARATOR

Tap water

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Denatonium benzoate

Intervention Type DRUG

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.

Group Type ACTIVE_COMPARATOR

Quinine hydrochloride

Intervention Type DRUG

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.

Group Type PLACEBO_COMPARATOR

Tap water

Intervention Type DRUG

Interventions

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Denatonium benzoate

Intervention Type DRUG

Quinine hydrochloride

Intervention Type DRUG

Tap water

Intervention Type DRUG

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes