Satiety ResponseGustoNCT05313347
Neural Correlates of Sensory Specific Satiety
An observational study of Satiety Response and Functional Neuroimaging, run by University of Heidelberg Medical Center at 1 site in Germany.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 18 to 55 years
- Conditions the study is for
- Satiety Response, Functional Neuroimaging, Obesity
- How many people
- 30 participants
- Where
- 1 siteGermany
- Study dates
- 1 Feb 2022to 1 Oct 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 55 years
- All sexes
- Adult
Study population: Healthy controls with BMI between 17,5 and 35 kg/m².
Who may be able to join
- BMI between 17,5 and 35 kg/m².
- Over age of 18 years.
- Right-handedness.
- Normal or corrected-to-normal vision.
- Capacity to consent.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read the 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.
- Conditions
- Satiety Response, Functional Neuroimaging, Obesity
- Keywords
- fmri, sensory specific satiety
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Healty Participants with varying BMI | 30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Choice of water compared to choice of sugar during Sensory Specific Satiety.
Comparing tasting of water with tasting of sugar (G10%) when participants are allowed to freely chose between the two during specific satiety for sugar.
Measured: 1 hour
Choice of water compared to passive ingestion of 20% sugar solution during Sensory Specific Satiety.
Comparison of voluntary tasting of water with the "forced" tasting of sugar during specific satiety for sugar.
Measured: 1 hour
Secondary outcomes (1)
Influence of variations in BMI on brain activation during Sensory Specific Satiety.
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Apr 2022
- Study start1 Feb 2022
- Primary completion1 Jul 2023
- Study completion1 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Satiety ResponseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Heidelberg Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Joe Simon, University of Heidelberg Medical Center
- Investigators
- joe simon, Ph.D., Principal investigator, Heidelberg University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05313347
- Sponsor's protocol ID
- S-656/2019-2
- Acronym
- Gusto
- Status last verified
- Nov 2023
- First submitted
- 28 Mar 2022
- Last updated
- 29 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study to Investigate Neural Processing During Sensory Specific Satiety Using Gustatory Stimulation
- ClinicalTrials.gov ID
- NCT05313347
- Acronym / sponsor ID
- Gusto / S-656/2019-2
- Conditions
- Satiety Response, Functional Neuroimaging, Obesity
- Keywords
- fmri, sensory specific satiety
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- University of Heidelberg Medical CenterUniversity, hospital or other
- Study start
- 1 Feb 2022 (actual)
- Primary completion
- 1 Jul 2023 (actual)
- Study completion
- 1 Oct 2023 (actual)
- First posted
- 6 Apr 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case only
- Time perspective
- Cross-sectional
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healty Participants with varying BMI | – | –30 healthy participants with a body mass index ranging from 17.5 to 35kg/m2. |
Who may qualify
- Ages
- 18 to 55 years
- Sex
- All
- Age groups
- Adult
- Study population
- Healthy controls with BMI between 17,5 and 35 kg/m².
Key inclusion criteria (5 listed)
- BMI between 17,5 and 35 kg/m².
- Over age of 18 years.
- Right-handedness.
- Normal or corrected-to-normal vision.
- Capacity to consent.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Choice of water compared to choice of sugar during Sensory Specific Satiety.
Time frame: 1 hour
Comparing tasting of water with tasting of sugar (G10%) when participants are allowed to freely chose between the two during specific satiety for sugar.
Choice of water compared to passive ingestion of 20% sugar solution during Sensory Specific Satiety.
Time frame: 1 hour
Comparison of voluntary tasting of water with the "forced" tasting of sugar during specific satiety for sugar.
1 secondary outcome
Influence of variations in BMI on brain activation during Sensory Specific Satiety.
Time frame: 1 hour
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Nov 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
joe simon, Ph.D. principal investigator
Heidelberg University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Satiety Response and Functional Neuroimaging, run by University of Heidelberg Medical Center at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Choice of water compared to choice of sugar during Sensory Specific Satiety. (time frame: 1 hour). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Nov 2023.