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

U

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

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

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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