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Taste Physiology in Obese Volunteers Before and After Bariatric Surgery

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02902198
Recruitment Status : Recruiting
First Posted : September 15, 2016
Last Update Posted : August 18, 2020
Sponsor:
Information provided by (Responsible Party):
University Hospital, Basel, Switzerland

Brief Summary:
The objective is to investigate neuro-anatomical correlates of gastrointestinal taste stimulation by means of functional MRI before and after bariatric surgery. Intragastric administration of glucose, monosodium glutamate, chloroquine and placebo is followed by functional brain MRI in obese humans before and 3 months after surgery.

Condition or disease Intervention/treatment Phase
Obesity Dietary Supplement: Placebo Dietary Supplement: Glucose Dietary Supplement: Monosodium glutamate Dietary Supplement: Quinine Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Basic Science
Official Title: Taste Physiology in Obese Volunteers Before and After Bariatric Surgery
Actual Study Start Date : December 2014
Estimated Primary Completion Date : July 2021
Estimated Study Completion Date : July 2021

Resource links provided by the National Library of Medicine

Drug Information available for: Quinine

Arm Intervention/treatment
Placebo Comparator: Placebo preoperative
Single intragastric instillation of 200ml tap water via nasogastric tube
Dietary Supplement: Placebo
Tap water 200ml

Placebo Comparator: Placebo postoperative
Single intragastric instillation of 200ml tap water via nasogastric tube
Dietary Supplement: Placebo
Tap water 200ml

Active Comparator: Glucose preoperative
Single intragastric instillation of 200ml tap water with 25g glucose via nasogastric tube
Dietary Supplement: Glucose
25g Glucose in 200ml tap water

Active Comparator: Glucose postoperative
Single intragastric instillation of 200ml tap water with 25g glucose via nasogastric tube
Dietary Supplement: Glucose
25g Glucose in 200ml tap water

Active Comparator: Monosodium glutamate preoperative
Single intragastric instillation of 200ml tap water with 1g monosodium glutamate via nasogastric tube
Dietary Supplement: Monosodium glutamate
1g monosodium glutamate in 200ml tap water

Active Comparator: Monosodium glutamate postoperative
Single intragastric instillation of 200ml tap water with 1g monosodium glutamate via nasogastric tube
Dietary Supplement: Monosodium glutamate
1g monosodium glutamate in 200ml tap water

Active Comparator: Quinine preoperative
Single intragastric instillation of 200ml tap water with 17mg quinine via nasogastric tube
Dietary Supplement: Quinine
17mg quinine in 200ml tap water

Active Comparator: Quinine postoperative
Single intragastric instillation of 200ml tap water with 17mg quinine via nasogastric tube
Dietary Supplement: Quinine
17mg quinine in 200ml tap water




Primary Outcome Measures :
  1. Effect of tastants on cerebral blood flow measured by functional brain MRI [ Time Frame: changes from baseline to one hour after treatment ]

Secondary Outcome Measures :
  1. Effect of tastants plasma glucagon-like peptide (GLP-1) concentrations [ Time Frame: changes from baseline to one hour after treatment ]
  2. Effect of tastants plasma ghrelin concentrations [ Time Frame: changes from baseline to one hour after treatment ]


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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • morbidly obese patients (BMI min 35kg/m2) scheduled for bariatric surgery
  • right handed

Exclusion Criteria:

  • cardiovascular disease
  • neurologic/psychiatric disorders

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02902198


Contacts
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Contact: Bettina Wölnerhanssen, Dr bettina.woelnerhanssen@usb.ch

Locations
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Switzerland
University Hopital Basel Recruiting
Basel, Switzerland
Contact: Bettina Wölnerhanssen, Dr       bettina.woelnerhanssen@usb.ch   
Sponsors and Collaborators
University Hospital, Basel, Switzerland
Investigators
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Study Chair: Christoph Beglinger, Prof University Basel
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Responsible Party: University Hospital, Basel, Switzerland
ClinicalTrials.gov Identifier: NCT02902198    
Other Study ID Numbers: fMRI Taste 2
First Posted: September 15, 2016    Key Record Dates
Last Update Posted: August 18, 2020
Last Verified: August 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Additional relevant MeSH terms:
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Quinine
Antimalarials
Antiprotozoal Agents
Antiparasitic Agents
Anti-Infective Agents
Muscle Relaxants, Central
Physiological Effects of Drugs
Neuromuscular Agents
Peripheral Nervous System Agents
Analgesics, Non-Narcotic
Analgesics
Sensory System Agents