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

Primary Purpose

Healthy, Obesity

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Denatonium benzoate
Quinine hydrochloride
Tap water
Sponsored by
Universitaire Ziekenhuizen KU Leuven
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Healthy focused on measuring Healthy volunteers, Obesity, Bitter

Eligibility Criteria

18 Years - 60 Years (Adult)All SexesAccepts 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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm 3

    Arm 4

    Arm 5

    Arm 6

    Arm Type

    Active Comparator

    Active Comparator

    Placebo Comparator

    Active Comparator

    Active Comparator

    Placebo Comparator

    Arm Label

    Denatonium benzoate intragastric

    Quinine hydrochloride intragastric

    Tap water intragastric

    Denatonium benzoate intraduodenal

    Quinine hydrochloride intraduodenal

    Tap water intraduodenal

    Arm Description

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

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

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

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

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

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

    Outcomes

    Primary Outcome Measures

    Change in gastrointestinal motility measured by antroduodenal high-resolution manometry

    Secondary Outcome Measures

    Change in gut hormone release measured by specific radioactive immunoassays
    Change in food intake measured by the caloric content of the meal
    Change in subjective hunger and satiety scores measured by visual analogue scales of 100 mm

    Full Information

    First Posted
    April 25, 2016
    Last Updated
    April 29, 2016
    Sponsor
    Universitaire Ziekenhuizen KU Leuven
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    1. Study Identification

    Unique Protocol Identification Number
    NCT02759926
    Brief Title
    The Effect of Bitter Taste Receptor Agonists on The Gastrointestinal Tract, Hunger and Food Intake
    Official Title
    The Role of Bitter Taste Receptors Expressed in the Gastrointestinal Tract in Altering Food Intake and Gastrointestinal Motility
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2016
    Overall Recruitment Status
    Unknown status
    Study Start Date
    August 2011 (undefined)
    Primary Completion Date
    November 2015 (Actual)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Universitaire Ziekenhuizen KU Leuven

    4. Oversight

    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Healthy, Obesity
    Keywords
    Healthy volunteers, Obesity, Bitter

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Crossover Assignment
    Masking
    Participant
    Allocation
    Randomized
    Enrollment
    98 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    Denatonium benzoate intragastric
    Arm Type
    Active Comparator
    Arm Description
    1 µmol/kg bodyweight (10mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
    Arm Title
    Quinine hydrochloride intragastric
    Arm Type
    Active Comparator
    Arm Description
    10 µmol/kg bodyweight (100mM) was administered as a bolus into the stomach through a nasogastric feeding tube.
    Arm Title
    Tap water intragastric
    Arm Type
    Placebo Comparator
    Arm Description
    An equal amount of tap water was administered as a bolus into the stomach through a nasogastric feeding tube.
    Arm Title
    Denatonium benzoate intraduodenal
    Arm Type
    Active Comparator
    Arm Description
    1 µmol/kg bodyweight (10mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
    Arm Title
    Quinine hydrochloride intraduodenal
    Arm Type
    Active Comparator
    Arm Description
    10 µmol/kg bodyweight (100mM) was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
    Arm Title
    Tap water intraduodenal
    Arm Type
    Placebo Comparator
    Arm Description
    An equal amount of tap water was administered as a bolus into the proximal part of the duodenum through a nasogastric feeding tube.
    Intervention Type
    Drug
    Intervention Name(s)
    Denatonium benzoate
    Intervention Type
    Drug
    Intervention Name(s)
    Quinine hydrochloride
    Intervention Type
    Drug
    Intervention Name(s)
    Tap water
    Primary Outcome Measure Information:
    Title
    Change in gastrointestinal motility measured by antroduodenal high-resolution manometry
    Time Frame
    2 hours after administration, continuous measurement with high resolution manometry
    Secondary Outcome Measure Information:
    Title
    Change in gut hormone release measured by specific radioactive immunoassays
    Time Frame
    2 hours after administration, blood sample every 10 min
    Title
    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
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Jan Tack, Prof
    Organizational Affiliation
    Universitaire Ziekenhuizen KU Leuven
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    28148502
    Citation
    Deloose E, Janssen P, Corsetti M, Biesiekierski J, Masuy I, Rotondo A, Van Oudenhove L, Depoortere I, Tack J. Intragastric infusion of denatonium benzoate attenuates interdigestive gastric motility and hunger scores in healthy female volunteers. Am J Clin Nutr. 2017 Mar;105(3):580-588. doi: 10.3945/ajcn.116.138297. Epub 2017 Feb 1.
    Results Reference
    derived

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

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