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

April 29, 2016 updated by: Universitaire Ziekenhuizen KU Leuven

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

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.

Study Overview

Study Type

Interventional

Enrollment (Anticipated)

98

Phase

  • Not Applicable

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Single

Arms and Interventions

Participant Group / 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.
Active Comparator: Quinine hydrochloride intragastric
10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
Placebo Comparator: Tap water intragastric
An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.
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.
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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
Time Frame: 2 hours after administration, continuous measurement with high resolution manometry
2 hours after administration, continuous measurement with high resolution manometry

Secondary Outcome Measures

Outcome Measure
Time Frame
Change in gut hormone release measured by specific radioactive immunoassays
Time Frame: 2 hours after administration, blood sample every 10 min
2 hours after administration, blood sample every 10 min
Change in food intake measured by the caloric content of the meal
Time Frame: ad libitum food intake for 1 hour, 40 min after administration
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
Time Frame: 2 hours after administration, assessment every 5 min
2 hours after administration, assessment every 5 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Jan Tack, Prof, Universitaire Ziekenhuizen KU Leuven

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2011

Primary Completion (Actual)

November 1, 2015

Study Registration Dates

First Submitted

April 25, 2016

First Submitted That Met QC Criteria

April 29, 2016

First Posted (Estimate)

May 3, 2016

Study Record Updates

Last Update Posted (Estimate)

May 3, 2016

Last Update Submitted That Met QC Criteria

April 29, 2016

Last Verified

April 1, 2016

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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