ObesityBRATNCT02483663
Brain Regulation of Appetite in Twins
An observational study of Obesity and Appetite, run by University of Washington at 1 site in United States.
Trial summary
Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- What is being tested?
- Functional Magnetic Resonance Imaging, Dual Energy X-ray absorptiometry and Questionnaires
- Type of treatment
- Injection or infusion, Medical device, Surgery or procedure
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2010to Aug 2015
- 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 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry
Who may be able to join
- Ability and willingness to come with their twin to the University of Washington (Seattle)
- Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or
- Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2
- Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2
Who cannot join
- History of weight loss surgery or active participation in weight loss program
- Major medical problem (e.g., diabetes, cancer)
- Current use of weight loss medications or other medications known to alter appetite
- Pregnancy or menopause
- MRI contraindication (i.e., implanted metal, claustrophobia)
- Lifetime eating disorder
Show all 13Show fewer
- Current smoking
- Current heavy alcohol use (≥2 drinks per day for females and ≥ 3 drinks per day for males)
- Self-reported weight >330 pounds at time of phone screening. MRI cannot accommodate all shapes or weights. Inability to have MRI does not exclude subject from participating in other study procedures.
- BMI < 18.5 or > 45 kg/m^2
- Allergies to study foods or inability to taste
- Twins were raised apart
- Co-twin not eligible or not willing to participate
Trial locations and contacts
1 site in 1 country.
About this study
Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.
- Being tested
- Functional Magnetic Resonance Imaging, Dual Energy X-ray absorptiometry, Questionnaires, Mood and Appetite Ratings, Test Meals
- Keywords
- Twins, Obesity, Appetite
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Functional Magnetic Resonance ImagingDevice
Also called fMRI
Measure brain activity.
Dual Energy X-ray absorptiometryRadiation
Also called DXA
Body composition measurements.
QuestionnairesOther
Questionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself.
Mood and Appetite RatingsOther
Answer questions about how you are feeling at the moment.
Test MealsOther
Breakfast, a snack, and lunch provided during study visit.
Computer TestsOther
Perform a series of computer tests to determine reaction time.
Intravenous Catheter (IV) placementProcedure or surgery
Blood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene.
| Study group | Role | What they receive |
|---|---|---|
| 27 Monozygotic Pairs | Not described Receives: Device: Functional Magnetic Resonance Imaging; Radiation: Dual Energy X-ray absorptiometry; Other: Questionnaires; Other: Mood and Appetite Ratings; Other: Test Meals; Other: Computer Tests; Procedure: Intravenous Catheter (IV) placement | |
| 27 Dizygotic Pairs | Not described Receives: Device: Functional Magnetic Resonance Imaging; Radiation: Dual Energy X-ray absorptiometry; Other: Questionnaires; Other: Mood and Appetite Ratings; Other: Test Meals; Other: Computer Tests; Procedure: Intravenous Catheter (IV) placement |
What is being measured
The primary outcome is the main question the study is designed to answer.
Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)
Measured: Baseline
Brain activation during fMRI in satiety-related regions
Measured: Baseline
Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)
Measured: Baseline
DNA evaluation of FTO genotypes
Measured: Baseline
Objective satiety: caloric and macronutrient intake
Measured: Baseline
Subjective satiety: visual analog scale (VAS) scores and appeal ratings
Measured: Baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jun 2015 (estimated)
- Study startAug 2010
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University of WashingtonThe sponsor's other registered studies.
- 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
- Family based
- Time perspective
- Prospective
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Washington
- Sponsor type
- University, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Columbia University
- Responsible party
- Principal investigator, Ellen Schur, MD, MS, University of Washington
- Investigators
- Ellen Schur, MD, MS, Principal investigator, University of Washington
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02483663
- Sponsor's protocol ID
- 38970
- Acronym
- BRAT
- Status last verified
- Oct 2017
- First submitted
- 17 Jun 2015
- Last updated
- 27 Oct 2017
- Results posted
- No
Publications
Melhorn SJ, Askren MK, Chung WK, Kratz M, Bosch TA, Tyagi V, Webb MF, De Leon MRB, Grabowski TJ, Leibel RL, Schur EA. FTO genotype impacts food intake and corticolimbic activation. Am J Clin Nutr. 2018 Feb 1;107(2):145-154. doi: 10.1093/ajcn/nqx029.
PubMed 29529147Mestre ZL, Melhorn SJ, Askren MK, Tyagi V, Gatenby C, Young L, Mehta S, Webb MF, Grabowski TJ, Schur EA. Effects of Anxiety on Caloric Intake and Satiety-Related Brain Activation in Women and Men. Psychosom Med. 2016 May;78(4):454-64. doi: 10.1097/PSY.0000000000000299.
PubMed 26867073Melhorn SJ, Mehta S, Kratz M, Tyagi V, Webb MF, Noonan CJ, Buchwald DS, Goldberg J, Maravilla KR, Grabowski TJ, Schur EA. Brain regulation of appetite in twins. Am J Clin Nutr. 2016 Feb;103(2):314-22. doi: 10.3945/ajcn.115.121095. Epub 2016 Jan 6.
PubMed 26739033
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Brain Regulation of Appetite in Twins
- ClinicalTrials.gov ID
- NCT02483663
- Acronym / sponsor ID
- BRAT / 38970
- Keywords
- Twins, Obesity, Appetite
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- University of WashingtonUniversity, hospital or other
- Collaborators
- Fred Hutchinson Cancer Center, Columbia University
- Study start
- Aug 2010
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 29 Jun 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.
Scientists are examining the genetic and environmental influences on appetite and weight gain. The main purpose of this study is to look at how genetic and environmental factors may influence how the brain regulates appetite and food intake. Understanding how the brain regulates appetite and food intake may eventually lead to new ways to help people avoid obesity or lose weight.
Study design
- Observational model
- Family based
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 27 Monozygotic Pairs | – | Device: Functional Magnetic Resonance Imaging, Radiation: Dual Energy X-ray absorptiometry, Other: Questionnaires, Other: Mood and Appetite Ratings, Other: Test Meals, Other: Computer Tests, Procedure: Intravenous Catheter (IV) placement |
| 27 Dizygotic Pairs | – | Device: Functional Magnetic Resonance Imaging, Radiation: Dual Energy X-ray absorptiometry, Other: Questionnaires, Other: Mood and Appetite Ratings, Other: Test Meals, Other: Computer Tests, Procedure: Intravenous Catheter (IV) placement |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Monozygotic and dizygotic twins recruited from the University of Washington Twin Registry
Key inclusion criteria (4 listed)
- Ability and willingness to come with their twin to the University of Washington (Seattle)
- Additional Criteria for Aim 1 random sample only: Member of randomly selected MZ pair or
- Additional criteria for Aim 2 random sample only: One member of MZ or same-sex DZ pair with BMI of at least 30 kg/m^2
- Additional criteria for Aim 3 sample only: Member of randomly selected MZ pair, and not BMI discordant ≥ 5 kg/m^2
Key exclusion criteria (13 listed)
- History of weight loss surgery or active participation in weight loss program
- Major medical problem (e.g., diabetes, cancer)
- Current use of weight loss medications or other medications known to alter appetite
- Pregnancy or menopause
- MRI contraindication (i.e., implanted metal, claustrophobia)
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 |
|---|---|---|
| Functional Magnetic Resonance ImagingAlso: fMRIMeasure brain activity. | Device | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| Dual Energy X-ray absorptiometryAlso: DXABody composition measurements. | Radiation | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| QuestionnairesQuestionnaires related to: health, weight, sleep, mood, dietary habits, attitudes towards eating, how you describe yourself. | Other | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| Mood and Appetite RatingsAnswer questions about how you are feeling at the moment. | Other | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| Test MealsBreakfast, a snack, and lunch provided during study visit. | Other | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| Computer TestsPerform a series of computer tests to determine reaction time. | Other | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
| Intravenous Catheter (IV) placementBlood samples collected throughout regular intervals during the study visit day to measure levels of hormones involved in regulating appetite and body weight. We will also determine if twins are fraternal or identical and will examine DNA to see if participants carry two genes that affect appetite or body weight, the FTO gene and the MC4R gene. | Procedure or surgery | 27 Dizygotic Pairs, 27 Monozygotic Pairs |
Primary outcome
Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose)
Time frame: Baseline
Brain activation during fMRI in satiety-related regions
Time frame: Baseline
Body composition: fasting leptin and dual energy X-ray absorptiometry (DXA)
Time frame: Baseline
DNA evaluation of FTO genotypes
Time frame: Baseline
Objective satiety: caloric and macronutrient intake
Time frame: Baseline
Subjective satiety: visual analog scale (VAS) scores and appeal ratings
Time frame: Baseline
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 27 Oct 2017.
- Derived from this study: PubMed 29529147Melhorn SJ, Askren MK, Chung WK, Kratz M, Bosch TA, Tyagi V, Webb MF, De Leon MRB, Grabowski TJ, Leibel RL, Schur EA. FTO genotype impacts food intake and corticolimbic activation. Am J Clin Nutr. 2018 Feb 1;107(2):145-154. doi: 10.1093/ajcn/nqx029.
- Derived from this study: PubMed 26867073Mestre ZL, Melhorn SJ, Askren MK, Tyagi V, Gatenby C, Young L, Mehta S, Webb MF, Grabowski TJ, Schur EA. Effects of Anxiety on Caloric Intake and Satiety-Related Brain Activation in Women and Men. Psychosom Med. 2016 May;78(4):454-64. doi: 10.1097/PSY.0000000000000299.
- Derived from this study: PubMed 26739033Melhorn SJ, Mehta S, Kratz M, Tyagi V, Webb MF, Noonan CJ, Buchwald DS, Goldberg J, Maravilla KR, Grabowski TJ, Schur EA. Brain regulation of appetite in twins. Am J Clin Nutr. 2016 Feb;103(2):314-22. doi: 10.3945/ajcn.115.121095. Epub 2016 Jan 6.
- UW Twin RegistryLink provided by the sponsor.
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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.
Ellen Schur, MD, MS principal investigator
University of Washington
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 Obesity and Appetite, run by University of Washington at 1 site in United States.
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 13 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 27 Oct 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 United States. 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?
Meal-induced nutrient and hormonal changes in plasma (insulin, GLP-1, ghrelin, glucose) (time frame: Baseline). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02483663, which also lists 3 linked publications.
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 27 Oct 2017.