Obesity Clinical Trial
Official title:
Randomized, Pilot Study to Compare the Effects of a Novel Dietary Intervention With the Post-operative Standard of Care on Body Composition After Laparoscopic Gastric Bypass Surgery
We propose to compare the standard of care with the use of a novel medical food in 6 bariatric surgery patients by measuring outcomes of body composition, quality of life, hair loss, muscle strength, resting energy expenditure, and biochemical parameters.
STUDY SUMMARY The purpose of this pilot study is to compare a medical food intervention with
the dietary standard of care at Boston Medical Center, in obese women subjects undergoing
Roux-en Y gastric bypass surgery. Commercially available nutritional supplements will also
be provided as part of the study's protocol.
Subjects will be selected from surgical candidates of the Nutrition and Weight Management
Center who meet the study criteria. Subjects will be randomly assigned to one of the 2
groups (treatment and control). Subjects will be seen at the study site 2 weeks before
surgery and 4 weeks, 8 weeks, 12 weeks, and 6 months after surgery (for a total of 5
visits). Data recorded during the study visits will be used to assess post-operative
progress and will include: body composition, resting energy expenditure, muscle strength,
quality of life questionnaires, hair loss, and blood markers for insulin resistance,
nutritional state, organ function, lipid profile and inflammation. Safety indicators and
compliance will also be monitored.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care
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