ObesityNCT02038712
fMRI and Ghlrein in Obesity and Binge Eating Disorder
A study testing Fed Condition, Fasted condition and Blood samples in people with Obesity and Binge Eating Disorder, run by New York Obesity and Nutrition Research Center.
Trial summary
Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Read more about this study
- Who is it for?
- Ages 18 to 65 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity, Binge Eating Disorder
- What is being tested?
- Fed Condition, Fasted condition and Blood samples
- Type of treatment
- Surgery or procedure, Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- No sites listed yet
- Study dates
- Jun 2006to Sep 2013
- Phase
- Interventional
- 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 65 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Age 18-65 years
- BMI 30-50 kg/m2
- Weight stable (<5% change in body weight during past 3 months)
- Right handed
Who cannot join
- Smokers
- Regular use of medications
- Current or intended participation in a weight-loss program (diet or exercise)
- Females who are pregnant or lactating
About this study
Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.
Read the detailed description
Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.
- Conditions
- Obesity, Binge Eating Disorder
- Being tested
- Fed Condition, Fasted condition, Blood samples, Subjective appetite ratings, fMRI scan
- Keywords
- Obesity, Binge eating disorder, fMRI, gut hormones
- Medical subject headings
- Obesity, Binge-Eating Disorder
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fed ConditionDietary supplement
Also called Boost (Novartis Nutrition)
Subjects will consume a 600mL 600kcal liquid test meal
Fasted conditionDietary supplement
Subjects will consume 600mL plain water.
Blood samplesProcedure or surgery
Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min
Subjective appetite ratingsBehavioural
Appetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min.
fMRI scanProcedure or surgery
Blood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI).
| Study group | Role | What they receive |
|---|---|---|
| Binge eating disorder (BED) | Experimental | Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition. Receives: Dietary Supplement: Fed Condition; Dietary Supplement: Fasted condition; Procedure: Blood samples; Behavioral: Subjective appetite ratings; Procedure: fMRI scan |
| Control | Experimental | Blood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition. Receives: Dietary Supplement: Fed Condition; Dietary Supplement: Fasted condition; Procedure: Blood samples; Behavioral: Subjective appetite ratings; Procedure: fMRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
fMRI responses to food cues
Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.
Measured: 45 min
Secondary outcomes (2)
Gut hormone responses
Blood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min following the ingestion of the liquid test meal and analyzed to determine the gut hormone responses.
Measured: 120 min
Subjective appetite ratings
Subjective ratings of appetite will be collected using a visual analogue scale (VAS) at -15, 0, 10, 30, 60, 90, 120 min following the liquid test meal
Measured: 120 min
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jan 2014 (estimated)
- Study startJun 2006
- Primary completionDec 2008
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- New York Obesity and Nutrition Research Center
- Sponsor type
- University, hospital or other
- Collaborators
- Columbia University
- Responsible party
- Principal investigator, Dr. Allan Geliebter, New York Obesity and Nutrition Research Center
- Investigators
- Allan Geliebter, PhD, Principal investigator, New York Obesity Nutrition Research Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02038712
- Sponsor's protocol ID
- 06-164
- Status last verified
- Jan 2014
- First submitted
- 10 Jan 2014
- Last updated
- 16 Jan 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Jan 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- fMRI and Ghlrein in Obesity and Binge Eating Disorder
- ClinicalTrials.gov ID
- NCT02038712
- Acronym / sponsor ID
- 06-164
- Conditions
- Obesity, Binge Eating Disorder
- Keywords
- Obesity, Binge eating disorder, fMRI, gut hormones
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- New York Obesity and Nutrition Research CenterUniversity, hospital or other
- Collaborators
- Columbia University
- Study start
- Jun 2006
- Primary completion
- Dec 2008 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 16 Jan 2014 (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.
Binge Eating Disorder (BED) may be associated with he development of obesity. However, the pathogenesis of BED is currently unclear, thus making the development of treatment and prevention strategies for BED difficult. Differences in the mechanisms regulating food intake may go some way to reveal potential mechanisms for BED.The purpose of this study is to investigate the responses of key gut-derived hormones that are associated with the regulation of food intake and functional brain activity to food cues using fMRI in BED patients and weight matched controls.
Detailed description
Participants will attend the laboratory on two separate occasions following an overnight fast. Following baseline measures they will be provided wither with a 600mL (600kcal) liquid meal (Fed condition) or a volume matched amount of plain water (Fasted condition) to consume within 15 min in a randomized crossover design. Blood samples will be collected for during the subsequent 120min to measure the glucose, insulin and gut hormone responses, and subjective appetite ratings will be collected. 1500mg of acetaminophen will be added to each of the test drinks so that the appearance in the blood can be used as a proxy measure of gastric emptying. Participants will then undergo a 45min brain scan to assess the responses to visual and auditory food cues.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Binge eating disorder (BED) | Experimental | Dietary Supplement: Fed Condition, Dietary Supplement: Fasted condition, Procedure: Blood samples, Behavioral: Subjective appetite ratings, Procedure: fMRI scanBlood samples, subjective appetite ratings and fMRI scan will be collected in subjects who meet the current criteria for binge eating disorder (BED) in the fed condition and fasted condition. |
| Control | Experimental | Dietary Supplement: Fed Condition, Dietary Supplement: Fasted condition, Procedure: Blood samples, Behavioral: Subjective appetite ratings, Procedure: fMRI scanBlood samples, subjective appetite ratings and fMRI scan will be collected in subjects who do not meet the current criteria for BED (Controls) in the fed condition and fasted condition. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years
- BMI 30-50 kg/m2
- Weight stable (<5% change in body weight during past 3 months)
- Right handed
Key exclusion criteria (4 listed)
- Smokers
- Regular use of medications
- Current or intended participation in a weight-loss program (diet or exercise)
- Females who are pregnant or lactating
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fed ConditionAlso: Boost (Novartis Nutrition)Subjects will consume a 600mL 600kcal liquid test meal | Dietary supplement | Binge eating disorder (BED), Control |
| Fasted conditionSubjects will consume 600mL plain water. | Dietary supplement | Binge eating disorder (BED), Control |
| Blood samplesBlood samples will be collected at -15, 0, 10, 30, 60, 90, 120 min | Procedure or surgery | Binge eating disorder (BED), Control |
| Subjective appetite ratingsAppetite ratings will be collected at -15, 0, 10, 30, 60, 90, 120 min. | Behavioural | Binge eating disorder (BED), Control |
| fMRI scanBlood Oxygen Dependent (BOLD) signal response to pictures and words of food and non-food items will be measured using functional magnetic resonance imaging (fMRI). | Procedure or surgery | Binge eating disorder (BED), Control |
Primary outcome
fMRI responses to food cues
Time frame: 45 min
Blood oxygen dependent signal (BOLD) response in exposure to auditory and visual food cues will be measured during a fMRI scan and the difference between responses in the fed condition compared with those in the fasted condition.
2 secondary outcomes
Gut hormone responses
Time frame: 120 min
Subjective appetite ratings
Time frame: 120 min
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 16 Jan 2014.
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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.
Allan Geliebter, PhD principal investigator
New York Obesity Nutrition Research Center
Questions about this trial
What is this clinical trial studying?
A study testing Fed Condition, Fasted condition and Blood samples in people with Obesity and Binge Eating Disorder, run by New York Obesity and Nutrition Research Center.
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 4 inclusion and 4 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 16 Jan 2014. Status can change between updates, so confirm with the study contact before making plans.
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?
fMRI responses to food cues (time frame: 45 min). 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 16 Jan 2014.