Brain, Obesity, Dopamine and You Study (BODY)
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|ClinicalTrials.gov Identifier: NCT01094756|
Recruitment Status : Completed
First Posted : March 29, 2010
Last Update Posted : November 2, 2016
|Condition or disease||Intervention/treatment||Phase|
|Obesity||Dietary Supplement: meal replacements, psychotherapy, dietary education||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||82 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Central Dopamine Receptors In Obesity|
|Study Start Date :||July 2010|
|Actual Primary Completion Date :||June 2015|
|Actual Study Completion Date :||October 2016|
Active Comparator: Obese group - Group 1
If you have a BMI between 33kg - 45kg and weight under 350 lbs you could be in group 1.
Dietary Supplement: meal replacements, psychotherapy, dietary education
After the screening and scan days are completed, obese subjects will begin a lifestyle intervention program that includes dietary (low-calorie diet) and behavioral education topics. Treatment will be provided in individual weekly sessions. Each hour-long session will be led by a behavioral counselor or registered dietitian in the Weight Management Center at Washington University. The behavioral program will use cognitive-behavioral techniques to foster adherence to diet prescriptions and to build a supportive environment for the participant. The program will emphasize strategies of self-monitoring and goal-setting, and will include problem-solving, overcoming high-risk situations for unhealthy eating, relapse prevention, and strategies for long-term weight maintenance. Handouts will be provided for study subjects to allow them to record the setting and reaching of dietary goals, as well as summarize the key points of the educational content.
No Intervention: Lean group - Group 2
If you have a BMI between 18.5 kg - 24.9 kg you could be in group 2.
- To determine the status of postsynaptic D2-like receptor binding in humans with obesity. [ Time Frame: 1 year for each participant ]To test this hypothesis, we will measure D2-like receptor binding with PET and a specific, non-competitive D2-like receptor ligand NMB in obese and lean individuals.
- To determine the relationship between D2-like receptor binding, reward sensitivity and hedonic response to sweet tastes. [ Time Frame: 1 year per participant ]To test this hypothesis we will correlate D2-like receptor binding levels in the striatum with reward questionnaires and standardized assessments of sweet taste responses within each group.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01094756
|United States, Missouri|
|Washington University Medical School|
|St. Louis, Missouri, United States, 63110|
|Principal Investigator:||Tamara Hershey, Ph.D.||Washington University School of Medicine|