NCT01949636

Brief Summary

The purpose of this study is to test the dynamic vulnerability model of obesity using brain imaging.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
131

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started May 2012

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2012

Completed
1.2 years until next milestone

First Submitted

Initial submission to the registry

July 18, 2013

Completed
2 months until next milestone

First Posted

Study publicly available on registry

September 24, 2013

Completed
2.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2016

Completed
1.8 years until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2018

Completed
Last Updated

May 24, 2018

Status Verified

May 1, 2018

Enrollment Period

4.1 years

First QC Date

July 18, 2013

Last Update Submit

May 23, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • increases in BMI

    Whether increases in BMI are predicted by: elevated reward region responsivity and reduced inhibitory region responsivity to palatable food varying in sugar/fat content (measured during fMRI scan)

    1, 2, 3, and 4 years

Secondary Outcomes (1)

  • striatal response to palatable food receipt; reward response and inhibitory response to palatable food cues, and inhibitory control deficits/immediate reward bias

    1, 2, 3, and 4 years

Other Outcomes (1)

  • increases in BMI

    4 years

Study Arms (1)

lean adolescents

Other: Functional Magnetic Resonance Imaging

Interventions

Eligibility Criteria

Age14 Years - 16 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

130 lean adolescents between 14-16 years old with BMIs between the 25th and 75th percentile at baseline

You may qualify if:

  • between 14-16 years old
  • BMI between 25th and 75th percentile

You may not qualify if:

  • contraindicators of functional magnetic resonance imaging (fMRI)
  • metal implants
  • braces
  • pregnancy
  • symptoms of major psychiatric disorders (substance use disorders, conduct disorder, attention deficit hyperactive disorder, major depression, bipolar disorder, panic disorder, agoraphobia, generalized anxiety disorder)
  • binge eating
  • use of pyschoactive drugs
  • serious medical conditions (diabetes, brain injury)
  • smoking
  • dietary allergy to dairy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oregon Research Institute

Portland, Oregon, 97232, United States

Location

Related Publications (20)

  • Alsio J, Olszewski PK, Norback AH, Gunnarsson ZE, Levine AS, Pickering C, Schioth HB. Dopamine D1 receptor gene expression decreases in the nucleus accumbens upon long-term exposure to palatable food and differs depending on diet-induced obesity phenotype in rats. Neuroscience. 2010 Dec 15;171(3):779-87. doi: 10.1016/j.neuroscience.2010.09.046. Epub 2010 Sep 26.

    PMID: 20875839BACKGROUND
  • Berridge KC. 'Liking' and 'wanting' food rewards: brain substrates and roles in eating disorders. Physiol Behav. 2009 Jul 14;97(5):537-50. doi: 10.1016/j.physbeh.2009.02.044. Epub 2009 Mar 29.

    PMID: 19336238BACKGROUND
  • Cornier MA, Salzberg AK, Endly DC, Bessesen DH, Tregellas JR. Sex-based differences in the behavioral and neuronal responses to food. Physiol Behav. 2010 Mar 30;99(4):538-43. doi: 10.1016/j.physbeh.2010.01.008. Epub 2010 Jan 22.

    PMID: 20096712BACKGROUND
  • Davis C, Strachan S, Berkson M. Sensitivity to reward: implications for overeating and overweight. Appetite. 2004 Apr;42(2):131-8. doi: 10.1016/j.appet.2003.07.004.

    PMID: 15010176BACKGROUND
  • Felsted JA, Ren X, Chouinard-Decorte F, Small DM. Genetically determined differences in brain response to a primary food reward. J Neurosci. 2010 Feb 17;30(7):2428-32. doi: 10.1523/JNEUROSCI.5483-09.2010.

    PMID: 20164326BACKGROUND
  • Johnson PM, Kenny PJ. Dopamine D2 receptors in addiction-like reward dysfunction and compulsive eating in obese rats. Nat Neurosci. 2010 May;13(5):635-41. doi: 10.1038/nn.2519. Epub 2010 Mar 28.

    PMID: 20348917BACKGROUND
  • Kelley AE, Will MJ, Steininger TL, Zhang M, Haber SN. Restricted daily consumption of a highly palatable food (chocolate Ensure(R)) alters striatal enkephalin gene expression. Eur J Neurosci. 2003 Nov;18(9):2592-8. doi: 10.1046/j.1460-9568.2003.02991.x.

    PMID: 14622160BACKGROUND
  • Kiyatkin EA, Gratton A. Electrochemical monitoring of extracellular dopamine in nucleus accumbens of rats lever-pressing for food. Brain Res. 1994 Aug 1;652(2):225-34. doi: 10.1016/0006-8993(94)90231-3.

    PMID: 7953734BACKGROUND
  • Schultz W, Apicella P, Ljungberg T. Responses of monkey dopamine neurons to reward and conditioned stimuli during successive steps of learning a delayed response task. J Neurosci. 1993 Mar;13(3):900-13. doi: 10.1523/JNEUROSCI.13-03-00900.1993.

    PMID: 8441015BACKGROUND
  • Stice E, Davis K, Miller NP, Marti CN. Fasting increases risk for onset of binge eating and bulimic pathology: a 5-year prospective study. J Abnorm Psychol. 2008 Nov;117(4):941-6. doi: 10.1037/a0013644.

    PMID: 19025239BACKGROUND
  • Stice E, Yokum S, Blum K, Bohon C. Weight gain is associated with reduced striatal response to palatable food. J Neurosci. 2010 Sep 29;30(39):13105-9. doi: 10.1523/JNEUROSCI.2105-10.2010.

    PMID: 20881128BACKGROUND
  • Stice E, Yokum S, Bohon C, Marti N, Smolen A. Reward circuitry responsivity to food predicts future increases in body mass: moderating effects of DRD2 and DRD4. Neuroimage. 2010 May 1;50(4):1618-25. doi: 10.1016/j.neuroimage.2010.01.081. Epub 2010 Jan 29.

    PMID: 20116437BACKGROUND
  • Stoeckel LE, Weller RE, Cook EW 3rd, Twieg DB, Knowlton RC, Cox JE. Widespread reward-system activation in obese women in response to pictures of high-calorie foods. Neuroimage. 2008 Jun;41(2):636-47. doi: 10.1016/j.neuroimage.2008.02.031. Epub 2008 Mar 4.

    PMID: 18413289BACKGROUND
  • Volkow ND, Wang GJ, Telang F, Fowler JS, Thanos PK, Logan J, Alexoff D, Ding YS, Wong C, Ma Y, Pradhan K. Low dopamine striatal D2 receptors are associated with prefrontal metabolism in obese subjects: possible contributing factors. Neuroimage. 2008 Oct 1;42(4):1537-43. doi: 10.1016/j.neuroimage.2008.06.002. Epub 2008 Jun 13.

    PMID: 18598772BACKGROUND
  • Wang GJ, Volkow ND, Felder C, Fowler JS, Levy AV, Pappas NR, Wong CT, Zhu W, Netusil N. Enhanced resting activity of the oral somatosensory cortex in obese subjects. Neuroreport. 2002 Jul 2;13(9):1151-5. doi: 10.1097/00001756-200207020-00016.

    PMID: 12151759BACKGROUND
  • Wang GJ, Volkow ND, Logan J, Pappas NR, Wong CT, Zhu W, Netusil N, Fowler JS. Brain dopamine and obesity. Lancet. 2001 Feb 3;357(9253):354-7. doi: 10.1016/s0140-6736(00)03643-6.

    PMID: 11210998BACKGROUND
  • Yokum S, Ng J, Stice E. Attentional bias to food images associated with elevated weight and future weight gain: an fMRI study. Obesity (Silver Spring). 2011 Sep;19(9):1775-83. doi: 10.1038/oby.2011.168. Epub 2011 Jun 16.

    PMID: 21681221BACKGROUND
  • Yokum S, Bohon C, Berkman E, Stice E. Test-retest reliability of functional MRI food receipt, anticipated receipt, and picture tasks. Am J Clin Nutr. 2021 Aug 2;114(2):764-779. doi: 10.1093/ajcn/nqab096.

  • Yokum S, Stice E. Weight gain is associated with changes in neural response to palatable food tastes varying in sugar and fat and palatable food images: a repeated-measures fMRI study. Am J Clin Nutr. 2019 Dec 1;110(6):1275-1286. doi: 10.1093/ajcn/nqz204.

  • Shearrer GE, Stice E, Burger KS. Adolescents at high risk of obesity show greater striatal response to increased sugar content in milkshakes. Am J Clin Nutr. 2018 Jun 1;107(6):859-866. doi: 10.1093/ajcn/nqy050.

Related Links

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Eric Stice, Ph.D.

    Oregon Research Institute

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

July 18, 2013

First Posted

September 24, 2013

Study Start

May 1, 2012

Primary Completion

June 1, 2016

Study Completion

April 1, 2018

Last Updated

May 24, 2018

Record last verified: 2018-05

Locations