- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02255812
Taste Physiology in Healthy, Normal-weight Volunteers
September 30, 2014 updated by: University Hospital, Basel, Switzerland
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.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
- 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 Type
Interventional
Enrollment (Actual)
12
Phase
- Not Applicable
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
-
-
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Basel, Switzerland, CH-4031
- University Hospital
-
-
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 45 years (Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
Male
Description
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
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 Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: 200 mL tap water
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
|
|
Active Comparator: 2 g salt
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
|
|
Active Comparator: 1 g monosodium glutamate
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
changes from baseline to one hour after treatment
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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
|
changes from baseline to one hour after treatment
|
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
|
changes from baseline to one hour after treatment
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Christoph Beglinger, MD, University Hospital, Basel, Switzerland
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
March 1, 2013
Primary Completion (Actual)
October 1, 2013
Study Completion (Actual)
October 1, 2013
Study Registration Dates
First Submitted
August 6, 2014
First Submitted That Met QC Criteria
September 30, 2014
First Posted (Estimate)
October 3, 2014
Study Record Updates
Last Update Posted (Estimate)
October 3, 2014
Last Update Submitted That Met QC Criteria
September 30, 2014
Last Verified
September 1, 2014
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Anti-Infective Agents
- Peripheral Nervous System Agents
- Analgesics
- Sensory System Agents
- Analgesics, Non-Narcotic
- Anticoagulants
- Antiprotozoal Agents
- Antiparasitic Agents
- Neuromuscular Agents
- Chelating Agents
- Sequestering Agents
- Antimalarials
- Muscle Relaxants, Central
- Calcium Chelating Agents
- Citric Acid
- Sodium Citrate
- Quinine
Other Study ID Numbers
- EKBB 289/12/2
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.
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