Status:
COMPLETED
Effects of Macronutrient Diet on Brain Activity
Lead Sponsor:
Brigham and Women's Hospital
Collaborating Sponsors:
Boston Children's Hospital
Nutrition Science Initiative
Conditions:
Obesity
Eligibility:
All Genders
18-55 years
Phase:
NA
Brief Summary
This study will evaluate the effect of macronutrient diets on brain activity in homeostatic and mesolimbic reward regions.
Detailed Description
A question critical to the field of obesity is "what causes overweight and obese individuals to overeat?" One common explanation holds that weight gain at the population-level is caused by increases i...
Eligibility Criteria
Inclusion
- Aged 18 to 55 years
- BMI ≥ 23 kg/m2
- BMI \< 45 kg/m2 and weight ≤ 300 lbs (136 kg)
- Medical clearance from a primary care provider
- Student or employee at Framingham State University throughout enrollment in the study
- Community-based participants from the greater Framingham and Assabet Valley communities
- Willing and able to eat and drink only the foods and beverages on the study menus
- Willing to eat in the dining hall
- Willing to abstain from consuming alcohol during participation
- Additional
- Body circumference of \<64 in
- Willingness to undergo 2, 30-minute MRI scans
- Exclusion Criteria (as detailed in Framingham State Food Study, NCT02068885):
- Change in body weight exceeding ±10% during prior year
- Recent adherence to a special diet
- Recent adherence to a vigorous physical activity regimen (e.g., participation in a varsity sport)
- Chronic use of any medication or dietary supplement that could affect study outcomes
- Current smoking (1 cigarette in the last week)
- Heavy baseline alcohol consumption or history of binge drinking
- Physician diagnosis of a major medical/psychiatric illness or eating disorder
- Abnormal blood glucose, TSH, CBC, BUN, Creatinine
- ALT greater than 150% of the normal upper limit
- Plans for a vacation during the study that would preclude adherence to prescribed diet
- Additional exclusions for female participants: Irregular menstrual cycles; any change in birth control medication during the 3 months prior to enrollment; pregnancy or lactation during the 12 months prior to enrollment
- Additional
Exclusion
- Previous bariatric surgery
- Other contraindications to MRI scanning (severe claustrophobia/extensive orthopedic hardware/pacemaker, cerebral aneurysm clip)
Key Trial Info
Start Date :
November 1 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 30 2017
Estimated Enrollment :
72 Patients enrolled
Trial Details
Trial ID
NCT02300857
Start Date
November 1 2014
End Date
April 30 2017
Last Update
June 6 2019
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