NCT02902198

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.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
16

participants targeted

Target at below P25 for not_applicable obesity

Timeline
19mo left

Started Dec 2014

Longer than P75 for not_applicable obesity

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress88%
Dec 2014Dec 2027

Study Start

First participant enrolled

December 1, 2014

Completed
1.8 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2016

Completed
3 days until next milestone

First Posted

Study publicly available on registry

September 15, 2016

Completed
10.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

April 3, 2025

Status Verified

March 1, 2025

Enrollment Period

12 years

First QC Date

September 12, 2016

Last Update Submit

March 31, 2025

Conditions

Obesity

Outcome Measures

Primary Outcomes (1)

  • Effect of tastants on cerebral blood flow measured by functional brain MRI

    changes from baseline to one hour after treatment

Secondary Outcomes (2)

  • Effect of tastants plasma glucagon-like peptide (GLP-1) concentrations

    changes from baseline to one hour after treatment

  • Effect of tastants plasma ghrelin concentrations

    changes from baseline to one hour after treatment

Study Arms (8)

Placebo preoperative

PLACEBO COMPARATOR

Single intragastric instillation of 200ml tap water via nasogastric tube

Dietary Supplement: Placebo

Placebo postoperative

PLACEBO COMPARATOR

Single intragastric instillation of 200ml tap water via nasogastric tube

Dietary Supplement: Placebo

Glucose preoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 25g glucose via nasogastric tube

Dietary Supplement: Glucose

Glucose postoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 25g glucose via nasogastric tube

Dietary Supplement: Glucose

Monosodium glutamate preoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 1g monosodium glutamate via nasogastric tube

Dietary Supplement: Monosodium glutamate

Monosodium glutamate postoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 1g monosodium glutamate via nasogastric tube

Dietary Supplement: Monosodium glutamate

Quinine preoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 17mg quinine via nasogastric tube

Dietary Supplement: Quinine

Quinine postoperative

ACTIVE COMPARATOR

Single intragastric instillation of 200ml tap water with 17mg quinine via nasogastric tube

Dietary Supplement: Quinine

Interventions

PlaceboDIETARY_SUPPLEMENT

Tap water 200ml

Placebo postoperativePlacebo preoperative
GlucoseDIETARY_SUPPLEMENT

25g Glucose in 200ml tap water

Glucose postoperativeGlucose preoperative
Monosodium glutamateDIETARY_SUPPLEMENT

1g monosodium glutamate in 200ml tap water

Monosodium glutamate postoperativeMonosodium glutamate preoperative
QuinineDIETARY_SUPPLEMENT

17mg quinine in 200ml tap water

Quinine postoperativeQuinine preoperative

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • cardiovascular disease
  • neurologic/psychiatric disorders

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hopital Basel

Basel, Switzerland

RECRUITING

MeSH Terms

Conditions

Obesity

Interventions

GlucoseSodium GlutamateQuinine

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

HexosesMonosaccharidesSugarsCarbohydratesGlutamic AcidGlutamatesAmino Acids, AcidicAmino AcidsAmino Acids, Peptides, and ProteinsAmino Acids, DicarboxylicCinchona AlkaloidsAlkaloidsHeterocyclic CompoundsQuinuclidinesHeterocyclic Compounds, Bridged-RingQuinolinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Christoph Beglinger, Prof

    University Basel

    STUDY CHAIR

Central Study Contacts

Bettina Wölnerhanssen, Dr

CONTACT

bettina.woelnerhanssen@usb.ch

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2016

First Posted

September 15, 2016

Study Start

December 1, 2014

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

April 3, 2025

Record last verified: 2025-03

Data Sharing

IPD Sharing
Will not share

Locations

CH(1)