- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05313347
Neural Correlates of Sensory Specific Satiety (Gusto)
November 28, 2023 updated by: Joe Simon, University of Heidelberg Medical Center
A Pilot Study to Investigate Neural Processing During Sensory Specific Satiety Using Gustatory Stimulation
Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.The rewarding effect of sugar will be investigated in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2.
A gustatory stimulation paradigm designed to induce sensory specific satiety for glucose will be employed.
The aim is to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior.
Study Overview
Status
Completed
Conditions
Detailed Description
Sensory specific satiety, or the phenomenon that the pleasantness of a particular taste declines when certain types food are consumed to satiety, plays an important role in food choice and meal termination.
Since changes in taste, smell and appetite are commonly observed in obesity, previous studies investigated the relation of sensory specific satiety to weight gain, but observed conflicting results.
To gain a more detailed understanding of the relationship between sensory specific satiety and weight homeostasis, we will examine the rewarding effect of sugar in a group of 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2.
We will employ a gustatory stimulation paradigm designed to induce sensory specific satiety for glucose.
During fMRI scanning, glucose and water are applied orally using a gustometer.
Furthermore, relevant hormonal satiety parameters are measured, as well as dietary behavior and food preferences in everyday life.
This will allow us to assess neuronal stimulus processing in relation to the sensory satiety level and to investigate the relationship with everyday eating behavior.
A better understanding of factors contributing to the development and maintenance of overweight are crucial for the development of new treatment options for obesity.
Study Type
Observational
Enrollment (Actual)
30
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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Heidelberg, Germany
- University Hospital Heidelberg
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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 55 years (Adult)
Accepts Healthy Volunteers
N/A
Sampling Method
Non-Probability Sample
Study Population
Healthy controls with BMI between 17,5 and 35 kg/m².
Description
Inclusion Criteria:
- BMI between 17,5 and 35 kg/m².
- Over age of 18 years.
- Right-handedness.
- Normal or corrected-to-normal vision.
- Capacity to consent.
Exclusion Criteria:
- History of head injury or surgery.
- History of neurological disorder.
- Severe psychiatric comorbidity.
- Lifetime or current medical illness that could potentially affect appetite or weight (including eating disorders diagnosis)
- Smoking.
- Current psychotropic medication.
- Inability to undergo fMRI scan (e.g. metallic implants, claustrophobia, pacemakers).
- Pregnancy.
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
- Observational Models: Case-Only
- Time Perspectives: Cross-Sectional
Cohorts and Interventions
Group / Cohort |
|---|
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Healty Participants with varying BMI
30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Choice of water compared to choice of sugar during Sensory Specific Satiety.
Time Frame: 1 hour
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Comparing tasting of water with tasting of sugar (G10%) when participants are allowed to freely chose between the two during specific satiety for sugar.
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1 hour
|
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Choice of water compared to passive ingestion of 20% sugar solution during Sensory Specific Satiety.
Time Frame: 1 hour
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Comparison of voluntary tasting of water with the "forced" tasting of sugar during specific satiety for sugar.
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1 hour
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
|
Influence of variations in BMI on brain activation during Sensory Specific Satiety.
Time Frame: 1 hour
|
1 hour
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: joe simon, Ph.D., Heidelberg University
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)
February 1, 2022
Primary Completion (Actual)
July 1, 2023
Study Completion (Actual)
October 1, 2023
Study Registration Dates
First Submitted
March 28, 2022
First Submitted That Met QC Criteria
April 5, 2022
First Posted (Actual)
April 6, 2022
Study Record Updates
Last Update Posted (Actual)
November 29, 2023
Last Update Submitted That Met QC Criteria
November 28, 2023
Last Verified
November 1, 2023
More Information
Terms related to this study
Keywords
Other Study ID Numbers
- S-656/2019-2
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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