Taste Physiology in Healthy, Normal-weight Volunteers

• ClinicalTrials.gov Identifier: NCT02255812
• Recruitment Status: Completed
• First Posted: October 3, 2014
• Last Update Posted: October 3, 2014
• Sponsor: University Hospital, Basel, Switzerland
• Information provided by (Responsible Party): University Hospital, Basel, Switzerland

Tracking Information

• First Submitted Date: August 6, 2014
• First Posted Date: October 3, 2014
• Last Update Posted Date: October 3, 2014
• Study Start Date: March 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: September 30, 2014)

regional brain activity assessed by functional Magnetic Resonance Imaging (fMRI) [ Time Frame: changes from baseline to one hour after treatment ]

Changes in resting state functional connectivity

• Original Primary Outcome Measures: Same as current
• Change History: No Changes Posted

Current Secondary Outcome Measures (submitted: September 30, 2014)

• gastrointestinal satiation peptide secretion [ Time Frame: changes from baseline to one hour after treatment ]
  Unit of Measure: glucagon like peptide-1 (GLP-1) in pg/mL, peptide tyrosine tyrosine (PYY) in pg/mL and gastric inhibitory polypeptide (GIP) in pg/mL
• glucose and insulin secretion [ Time Frame: changes from baseline to one hour after treatment ]
  Unit of Measure: glucose in mmol/L, insulin in μU/mL

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: Taste Physiology in Healthy, Normal-weight Volunteers
• Official Title: Taste Physiology in Healthy, Normal-weight Volunteers
• Brief Summary: Taste physiology describes five main taste qualities in humans: sweet, sour, salty, umami and bitter. The receptors found on the tongue are also found in the entire gut. The correlation of stimulation of these gut receptors and brain activity has not yet been examined. The objectives are to investigate the effect of different taste substances on i) regional brain activity and ii) satiation peptide release.
• Detailed Description: Not Provided
• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: Randomized; Intervention Model: Crossover Assignment; Masking: Double (Participant, Investigator); Primary Purpose: Basic Science
• Condition: Exploratory Behavior

Intervention

• Dietary Supplement: Single intragastric instillation of 200 mL tap water via nasogastric tube
• Dietary Supplement: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube
• Dietary Supplement: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
• Dietary Supplement: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube
• Dietary Supplement: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
• Dietary Supplement: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube

Study Arms

• Placebo Comparator: 200 mL tap water
  Single intragastric instillation of 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 200 mL tap water via nasogastric tube
• Active Comparator: 2 g citric acid
  Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 2 g citric acid in 200 mL tap water via nasogastric tube
• Active Comparator: 2 g salt
  Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 2 g salt in 200 mL tap water via nasogastric tube
• Active Comparator: 0.017 g quinine
  Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 0.017 g quinine in 200 mL tap water via nasogastric tube
• Active Comparator: 1 g monosodium glutamate
  Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 1 g monosodium glutamate in 200 mL tap water via nasogastric tube
• Active Comparator: 25 g glucose
  Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube
  Intervention: Dietary Supplement: Single intragastric instillation of 25 g glucose in 200 mL tap water via nasogastric tube

• Publications *: Not Provided

Recruitment Information

• Recruitment Status: Completed
• Actual Enrollment (submitted: September 30, 2014): 12
• Original Actual Enrollment: Same as current
• Actual Study Completion Date: October 2013
• Actual Primary Completion Date: October 2013 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

• right-handed healthy males
• Body-mass index of < 25
• Age 18-45 years
• no drugs
• non-smoking

Exclusion Criteria:

• Smoking
• Substance abuse
• Regular intake of medications (except for oral contraceptives)
• Medical or psychiatric illness, especially: diabetes, pace-maker, claustrophobia
• History of gastrointestinal disorders
• Food allergies, glutamate intolerance
• Body piercings that cannot be removed

Sex/Gender

• Sexes Eligible for Study: Male

• Ages: 18 Years to 45 Years (Adult)
• Accepts Healthy Volunteers: Yes
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: Switzerland

Administrative Information

• NCT Number: NCT02255812
• Other Study ID Numbers: EKBB 289/12/2
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided
• IPD Sharing Statement: Not Provided
• Current Responsible Party: University Hospital, Basel, Switzerland
• Original Responsible Party: Same as current
• Current Study Sponsor: University Hospital, Basel, Switzerland
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Christoph Beglinger, MD; University Hospital, Basel, Switzerland

• PRS Account: University Hospital, Basel, Switzerland
• Verification Date: September 2014