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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01302574
Other study ID # EKBB 69/04.02
Secondary ID
Status Completed
Phase Phase 1
First received February 22, 2011
Last updated February 23, 2011
Start date January 2010
Est. completion date June 2010

Study information

Verified date February 2011
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 gastrointestinal (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 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.


Recruitment information / eligibility

Status Completed
Enrollment 16
Est. completion date June 2010
Est. primary completion date March 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years to 40 Years
Eligibility 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 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
Lactisole-liquid meal: Lactisole (450 ppm) will be mixed with a liquid meal. Liquid meal only: The comparator will be the liquid meal alone.

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, 

Outcome

Type Measure Description Time frame Safety issue
Primary Gastrointestinal peptide secretion 2 hours blood sampling No
Secondary Appetite perceptions 4 hours No
Secondary Gastric emptying rate 4 hours No
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