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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