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Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides

Primary Purpose

Taste Disorder, Secondary, Sweet

Status
Completed
Phase
Phase 1
Locations
Switzerland
Study Type
Interventional
Intervention
lactisole
Sponsored by
University Hospital, Basel, Switzerland
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Taste Disorder, Secondary, Sweet focused on measuring T1R2/T1R3, gastric emptying, gut, lactisole, nutrient sensing

Eligibility Criteria

18 Years - 40 Years (Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • healthy subjects
  • BMI of 19.0-24.5
  • age 18-40 years old
  • stable body weight for at least 3 month

Exclusion Criteria:

  • smoking
  • substance abuse
  • regular intake of medication
  • medical or psychiatric illness
  • gastrointestinal disorders or food allergies

Sites / Locations

  • University Hospital Basel, Phase 1 Research Unit

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Active Comparator

Arm Label

mixed liquid meal

mixed liquid meal + lactisole

Arm Description

500 mL mixed liquid meal + 50 mg 13C-sodium-acetate

500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole

Outcomes

Primary Outcome Measures

Gastrointestinal peptide secretion

Secondary Outcome Measures

Appetite perceptions
Gastric emptying rate

Full Information

First Posted
February 22, 2011
Last Updated
February 23, 2011
Sponsor
University Hospital, Basel, Switzerland
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1. Study Identification

Unique Protocol Identification Number
NCT01302574
Brief Title
Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
Official Title
The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
Study Type
Interventional

2. Study Status

Record Verification Date
February 2011
Overall Recruitment Status
Completed
Study Start Date
January 2010 (undefined)
Primary Completion Date
March 2010 (Actual)
Study Completion Date
June 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Basel, Switzerland

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The purpose of this study is to determine the functional significance of sweet taste receptors in the secretion of gastrointestinal (GI) satiation peptides by using a specific sweet taste receptor antagonist to block sweet taste perception in the gastrointestinal tract.
Detailed Description
There is strong evidence that taste signaling mechanisms identified in the oral epithelium also operate in the gut. It is suggested that open-type enteroendocrine cells directly sense nutrient via alpha-gustducin coupled taste receptors to modulate the secretion of glucagon like peptide-1 (GLP-1) and peptide YY (PYY). Several nutrient responsive G-protein coupled receptors have been identified in the human gut, including the sweet taste responsive T1R2/T1R3 heterodimer, the amino acid/umami responsive T1R1/T1R3 as well as GPR120 for unsaturated long-chain free fatty acids. The functional significance of sweet taste receptors in mixed liquid meal-stimulated secretion of GLP-1 and PYY will be determined by intragastric infusion of a 500 mL mixed liquid meal with or without lactisole (450 ppm)in a double blind, 2-way crossover trial including 16 healthy subjects.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Taste Disorder, Secondary, Sweet
Keywords
T1R2/T1R3, gastric emptying, gut, lactisole, nutrient sensing

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
mixed liquid meal
Arm Type
Placebo Comparator
Arm Description
500 mL mixed liquid meal + 50 mg 13C-sodium-acetate
Arm Title
mixed liquid meal + lactisole
Arm Type
Active Comparator
Arm Description
500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole
Intervention Type
Dietary Supplement
Intervention Name(s)
lactisole
Other Intervention Name(s)
Dietary supplement
Intervention Description
Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.
Primary Outcome Measure Information:
Title
Gastrointestinal peptide secretion
Time Frame
2 hours blood sampling
Secondary Outcome Measure Information:
Title
Appetite perceptions
Time Frame
4 hours
Title
Gastric emptying rate
Time Frame
4 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: healthy subjects BMI of 19.0-24.5 age 18-40 years old stable body weight for at least 3 month Exclusion Criteria: smoking substance abuse regular intake of medication medical or psychiatric illness gastrointestinal disorders or food allergies
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Christoph Beglinger, MD
Organizational Affiliation
Phase 1 Research Unit, University Hospital Basel
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Basel, Phase 1 Research Unit
City
Basel
ZIP/Postal Code
4031
Country
Switzerland

12. IPD Sharing Statement

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Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides

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