AdiposityNCT02427152
Pre-meal Planning and Expected Satiety
An observational study of Adiposity, run by University Hospital Tuebingen at 1 site in Germany.
Trial summary
Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Adiposity
- How many people
- 60 participants
- Where
- 1 siteGermany
- Study dates
- Mar 2015to Dec 2017
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: lean and overweight/obese healthy volunteers
Who may be able to join
- body mass index: 18-25 kg/m²; 25-35 kg/m²,
- right-handed,
- age: 18-35 years.
Who cannot join
- functional magnetic resonance imaging contraindications,
- claustrophobia,
- self-reported eating disorders,
- vegan or vegetarian diet, food allergies,
- intake of antidepressants,
- metabolic disorders.
Trial locations and contacts
1 site in 1 country.
Hege contact
Germany1 site, 1 recruiting
- Recruiting
University Clinic of Tuebingen, fMEG Center
Tübingen, 72076
About this study
Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. Further, also factors like weight concern and palatability of the food might have their influence on meal size selection. In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.
- Conditions
- Adiposity
- 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 |
|---|---|---|
| Lean | body mass index: 18-25 kg/m² | |
| Overweight/Obese | body mass index: >25 kg/m² |
What is being measured
The primary outcome is the main question the study is designed to answer.
Differential brain functions in reward, decision making and inhibitory control networks (brain functions will be measured by blood oxygen level dependent effects)
brain functions will be measured by blood oxygen level dependent effects
Measured: day 0
Secondary outcomes (1)
Differential behavioral measures of portion size selection
Measured: day 0
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Apr 2015 (estimated)
- Study startMar 2015
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for AdiposityStudies 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-control
- Time perspective
- Cross-sectional
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital Tuebingen
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02427152
- Sponsor's protocol ID
- Satt
- Status last verified
- May 2017
- First submitted
- 18 Mar 2015
- Last updated
- 31 May 2017
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pre-meal Planning and Expected Satiety
- ClinicalTrials.gov ID
- NCT02427152
- Acronym / sponsor ID
- Satt
- Conditions
- Adiposity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University Hospital TuebingenUniversity, hospital or other
- Study start
- Mar 2015
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 27 Apr 2015 (estimated)
- 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.
Obesity is considered to be caused by an imbalance between energy expenditure and energy intake. A major determinant of our daily energy intake is the size of the meals that we consume. It has been suggested that decisions about portion sizes are often made in advance, before a meal begins. This pre-meal planning is considered to especially depend on the estimated 'expected satiety' and 'expected satiation' of different foods. Further, also factors like weight concern and palatability of the food might have their influence on meal size selection. In general, it is not clear how these factors are integrated during pre-meal planning and which brain networks are involved in these decisions/this process. Thus, the investigators plan to study pre-meal planning in healthy, normal-weight and overweight/obese individuals with functional magnetic resonance imaging under different cognitive instructions including pleasure, expected satiety and self-control in terms of health consequences. The investigators will explore the neural networks involved in pre-meal planning and expect them to be modulated by the before mentioned factors. Further, the investigators plan to explore gender differences and expect that female subjects will select smaller portion sizes especially in the self-control condition as they are often more concerned about their weight/health. Finally, the investigators will explore differences between lean and overweight subjects to elucidate factors that might lead to increased meal sizes in overweight subjects.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Lean | – | –body mass index: 18-25 kg/m² |
| Overweight/Obese | – | –body mass index: >25 kg/m² |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- lean and overweight/obese healthy volunteers
Key inclusion criteria (3 listed)
- body mass index: 18-25 kg/m²; 25-35 kg/m²,
- right-handed,
- age: 18-35 years.
Key exclusion criteria (6 listed)
- functional magnetic resonance imaging contraindications,
- claustrophobia,
- self-reported eating disorders,
- vegan or vegetarian diet, food allergies,
- intake of antidepressants,
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
Differential brain functions in reward, decision making and inhibitory control networks (brain functions will be measured by blood oxygen level dependent effects)
Time frame: day 0
brain functions will be measured by blood oxygen level dependent effects
1 secondary outcome
Differential behavioral measures of portion size selection
Time frame: day 0
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2017.
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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.
Hege contact
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 Adiposity, run by University Hospital Tuebingen 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 3 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 31 May 2017. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hege (maike.hege@med.uni-tuebingen.de), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Differential brain functions in reward, decision making and inhibitory control networks (brain functions will be measured by blood oxygen level dependent effects) (time frame: day 0). 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 31 May 2017.