- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01304823
Role of the Gut Sweet Taste Receptor in the Secretion of Glucagon-like Peptide-1 and Peptide YY
July 15, 2015 updated by: University Hospital, Basel, Switzerland
The Role of Sweet Taste Receptor Blockade on Intraduodenal Glucose- and 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 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 the secretion of GLP-1 and PYY will be determined by intraduodenal perfusion of glucose (I) or a mixed liquid meal (II) with or without lactisole (450 ppm) in a double blind, 5-way crossover trial including 10 healthy subjects.
Study Type
Interventional
Enrollment (Actual)
10
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
-
-
-
Basel, Switzerland, 4031
- University Hospital Basel, Phase 1 Research Unit
-
-
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
Male
Description
Inclusion Criteria:
- Healthy subjects
- BMI of 19.0-24.5
- Age 18-40
- 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 |
---|---|
ACTIVE_COMPARATOR: glucose
intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min)
|
flavoring agent/sweet taste antagonist
Other Names:
|
ACTIVE_COMPARATOR: glucose + lactisole
intraduodenal perfusion of glucose (29.3 g glucose per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole
|
flavoring agent/sweet taste antagonist
Other Names:
|
ACTIVE_COMPARATOR: mixed liquid meal
intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min)
|
Ensure Plus
Other Names:
|
ACTIVE_COMPARATOR: mixed liquid meal + lactisole
intraduodenal perfusion of a mixed liquid meal (20.20 g carbohydrate, 4.92 g fat and 6.25 g protein per 100 mL; rate: 2.5 mL/min for 180 min; caloric load: 3.0 kcal/min) + 450 ppm lactisole
|
Ensure Plus
Other Names:
|
PLACEBO_COMPARATOR: saline + lactisole
saline (0.9 %; rate: 2.5 mL/min for 180 min) + 450 ppm lactisole
|
flavoring agent/sweet taste antagonist
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Gastrointestinal peptide secretion
Time Frame: 4 hours blood sampling
|
Assessment of venous GLP-1 and PYY release to meal stimulation with and without sweet receptor blockade
|
4 hours blood sampling
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Appetite perceptions during 4 hours using VAS
Time Frame: 4 hours
|
Assessment of the following appetite perception markers: feelings of hunger, feelings of fullness, feelings of satiety using validated visual analogue scales
|
4 hours
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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.
General Publications
- Steinert RE, Meyer-Gerspach AC, Beglinger C. The role of the stomach in the control of appetite and the secretion of satiation peptides. Am J Physiol Endocrinol Metab. 2012 Mar 15;302(6):E666-73. doi: 10.1152/ajpendo.00457.2011. Epub 2012 Jan 3.
- Steinert RE, Gerspach AC, Gutmann H, Asarian L, Drewe J, Beglinger C. The functional involvement of gut-expressed sweet taste receptors in glucose-stimulated secretion of glucagon-like peptide-1 (GLP-1) and peptide YY (PYY). Clin Nutr. 2011 Aug;30(4):524-32. doi: 10.1016/j.clnu.2011.01.007. Epub 2011 Feb 15.
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
June 1, 2010
Primary Completion (ACTUAL)
August 1, 2010
Study Completion (ACTUAL)
January 1, 2011
Study Registration Dates
First Submitted
February 22, 2011
First Submitted That Met QC Criteria
February 24, 2011
First Posted (ESTIMATE)
February 25, 2011
Study Record Updates
Last Update Posted (ESTIMATE)
July 16, 2015
Last Update Submitted That Met QC Criteria
July 15, 2015
Last Verified
July 1, 2015
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- EKBB 69/04.03
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.
Clinical Trials on Taste Disorder, Primary, Sweet
-
Monell Chemical Senses CenterPepsiCo Global R&DCompletedSweet Taste PerceptionUnited States
-
University Hospital, Basel, SwitzerlandCompletedTaste Disorder, Secondary, SweetSwitzerland
-
Johns Hopkins UniversityNational Institute on Drug Abuse (NIDA)CompletedFeeding Behavior | Taste Sweet | Taste SaltyUnited States
-
Rutgers, The State University of New JerseyMonell Chemical Senses CenterCompletedTreatment of Sweet Taste Receptors Without or With an Oral Rinse of Ibuprofen Solution in Healthy Participants | Treatment of Sweet Taste Receptors Without or With an Oral Rinse of Naproxen Solution in Healthy ParticipantsUnited States
-
Ministry of Health, Saudi ArabiaNot yet recruitingTaste Disorders | Smell Disorder | Smell Dysfunction | Taste Disorder, Secondary, Sweet | Taste Disorder, Secondary, Bitter
-
Purdue UniversityCompleted
-
National Institute on Deafness and Other Communication...Completed
-
Centre Hospitalier de ValenceCompletedSensation Disorders | Taste Disorders | Taste, Metallic | Taste Disorder, Glossopharyngeal NerveFrance
-
Markus R. FussneggerDeutsche Gesellschaft für Zahn-, Mund- und Kieferheilkunde e.V.UnknownOrofacial Pain | Burning Mouth Syndrome | Taste DisorderGermany
-
University Medical Centre LjubljanaRecruitingTaste Disorders | Chorda Tympani Disorder | Stapes FixationSlovenia
Clinical Trials on lactisole
-
University GhentVIBCompleted
-
University Hospital, Basel, SwitzerlandCompletedTaste Disorder, Secondary, SweetSwitzerland
-
University Hospital, Basel, SwitzerlandCompletedPhysiological Satiation MechanismsSwitzerland
-
Northern Care Alliance NHS Foundation TrustUniversity of ManchesterUnknownBlood Glucose | Hormones | Therapeutic Uses | AppetiteUnited Kingdom
-
University Hospital, Basel, SwitzerlandCompletedAppetite and General Nutritional Disorders | Hormone ReplacementSwitzerland
-
AdventHealth Translational Research InstituteCompletedObesityUnited States
-
University Hospital, Basel, SwitzerlandCompletedExploratory BehaviorSwitzerland
-
University of ViennaCompletedHunger | Blood Glucose, LowAustria