Taste Physiology in Obese Volunteers Before and After Bariatric Surgery

May 15, 2023 updated by: University Hospital, Basel, Switzerland
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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

16

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 Contact

Study Locations

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

16 years to 53 years (Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

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

Exclusion Criteria:

  • cardiovascular disease
  • neurologic/psychiatric disorders

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: Triple

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Effect of tastants on cerebral blood flow measured by functional brain MRI
Time Frame: changes from baseline to one hour after treatment
changes from baseline to one hour after treatment

Secondary Outcome Measures

Outcome Measure
Time Frame
Effect of tastants plasma glucagon-like peptide (GLP-1) concentrations
Time Frame: changes from baseline to one hour after treatment
changes from baseline to one hour after treatment
Effect of tastants plasma ghrelin concentrations
Time Frame: changes from baseline to one hour after treatment
changes from baseline to one hour after treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital, Basel, Switzerland

Investigators

  • Study Chair: Christoph Beglinger, Prof, University Basel

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 (Actual)

December 1, 2014

Primary Completion (Anticipated)

December 1, 2024

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

September 12, 2016

First Submitted That Met QC Criteria

September 12, 2016

First Posted (Estimate)

September 15, 2016

Study Record Updates

Last Update Posted (Actual)

May 16, 2023

Last Update Submitted That Met QC Criteria

May 15, 2023

Last Verified

May 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fMRI Taste 2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

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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Locations

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