Working...
ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 6 of 538 for:    Taste Disorders AND taste

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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01302574
Recruitment Status : Completed
First Posted : February 24, 2011
Last Update Posted : February 24, 2011
Sponsor:
Information provided by:
University Hospital, Basel, Switzerland

Tracking Information
First Submitted Date  ICMJE February 22, 2011
First Posted Date  ICMJE February 24, 2011
Last Update Posted Date February 24, 2011
Study Start Date  ICMJE January 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
Gastrointestinal peptide secretion [ Time Frame: 2 hours blood sampling ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE
 (submitted: February 23, 2011)
  • Appetite perceptions [ Time Frame: 4 hours ]
  • Gastric emptying rate [ Time Frame: 4 hours ]
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Role of the Gut Sweet Taste Receptor in the Secretion of Satiation Peptides
Official Title  ICMJE The Role of Sweet Taste Receptor Blockade on Intragastric Liquid Meal-stimulated Secretion of Satiation Peptides in Healthy Humans
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Study Design  ICMJE Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Basic Science
Condition  ICMJE Taste Disorder, Secondary, Sweet
Intervention  ICMJE 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.
Other Name: Dietary supplement
Study Arms  ICMJE
  • Placebo Comparator: mixed liquid meal
    500 mL mixed liquid meal + 50 mg 13C-sodium-acetate
    Intervention: Dietary Supplement: lactisole
  • Active Comparator: mixed liquid meal + lactisole
    500 mL mixed liquid meal + 50 mg 13C-sodium-acetate + 450 ppm lactisole
    Intervention: Dietary Supplement: lactisole
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: February 23, 2011)
16
Original Actual Enrollment  ICMJE Same as current
Actual Study Completion Date  ICMJE June 2010
Actual Primary Completion Date March 2010   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 40 Years   (Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Switzerland
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01302574
Other Study ID Numbers  ICMJE EKBB 69/04.02
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Beglinger Christoph, Prof. Dr. med., Department of Gastroenterology, University Hospital Basel, Basel, Switzerland
Study Sponsor  ICMJE University Hospital, Basel, Switzerland
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Christoph Beglinger, MD Phase 1 Research Unit, University Hospital Basel
PRS Account University Hospital, Basel, Switzerland
Verification Date February 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP