- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01302574
Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
February 23, 2011 updated by: University Hospital, Basel, Switzerland
The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
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.
Study Type
Interventional
Enrollment (Actual)
16
Phase
- Phase 1
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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Basel, Switzerland, 4031
- University Hospital Basel, Phase 1 Research Unit
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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 40 years (ADULT)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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
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
- Masking: QUADRUPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
PLACEBO_COMPARATOR: mixed liquid meal
500 mL mixed liquid meal + 50 mg 13C-sodium-acetate
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Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal.
Liquid meal only: The comparator will be the liquid meal alone.
Other Names:
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ACTIVE_COMPARATOR: mixed liquid meal + lactisole
500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole
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Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal.
Liquid meal only: The comparator will be the liquid meal alone.
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Gastrointestinal peptide secretion
Time Frame: 2 hours blood sampling
|
2 hours blood sampling
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Appetite perceptions
Time Frame: 4 hours
|
4 hours
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Gastric emptying rate
Time Frame: 4 hours
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4 hours
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Collaborators and Investigators
This is where you will find people and organizations involved with this 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
January 1, 2010
Primary Completion (ACTUAL)
March 1, 2010
Study Completion (ACTUAL)
June 1, 2010
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 23, 2011
First Posted (ESTIMATE)
February 24, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
February 24, 2011
Last Update Submitted That Met QC Criteria
February 23, 2011
Last Verified
February 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB 69/04.02
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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