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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01304823
Other study ID # EKBB 69/04.03
Secondary ID
Status Completed
Phase Phase 1
First received February 22, 2011
Last updated July 15, 2015
Start date June 2010
Est. completion date January 2011

Study information

Verified date July 2015
Source University Hospital, Basel, Switzerland
Contact n/a
Is FDA regulated No
Health authority Switzerland: Ethikkommission
Study type Interventional

Clinical Trial Summary

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.


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.


Recruitment information / eligibility

Status Completed
Enrollment 10
Est. completion date January 2011
Est. primary completion date August 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Male
Age group 18 Years to 40 Years
Eligibility 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 Design

Allocation: Randomized, Endpoint Classification: Pharmacodynamics Study, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Basic Science


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
lactisole
flavoring agent/sweet taste antagonist
Other:
mixed liquid meal
Ensure Plus

Locations

Country Name City State
Switzerland University Hospital Basel, Phase 1 Research Unit Basel

Sponsors (1)

Lead Sponsor Collaborator
University Hospital, Basel, Switzerland

Country where clinical trial is conducted

Switzerland, 

References & Publications (2)

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- — View Citation

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. — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Gastrointestinal peptide secretion Assessment of venous GLP-1 and PYY release to meal stimulation with and without sweet receptor blockade 4 hours blood sampling No
Secondary Appetite perceptions during 4 hours using VAS Assessment of the following appetite perception markers: feelings of hunger, feelings of fullness, feelings of satiety using validated visual analogue scales 4 hours No