- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02759926
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
Status
Unknown
Intervention / Treatment
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
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Overnutrition
- Nutrition Disorders
- Overweight
- Body Weight
- Obesity
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Antimalarials
- Muscle Relaxants, Central
- Aversive Agents
- Abuse-Deterrent Formulations
- Quinine
- Denatonium
Other Study ID Numbers
- BitterMotilityHungerFoodIntake
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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