Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery

• Total and extracellular water (by cold bromide and deuterium method) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ] [ Designated as safety issue: No ]
• Dual energy X-ray absorptiometry (DEXA) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ] [ Designated as safety issue: No ]

• Hair loss (by photographic method and Hair-Scalp Questionnaire) [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
• Impedance plethysmography (by distal and proximal electrode placement) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
• Muscle strength (by a handgrip dynamometer) [ Time Frame: Baseline, 4weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
• Resting energy expenditure (by indirect calorimetry) [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
• Pulse after a 6-minute walk [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
• Measures of insulin resistance, visceral protein/nutritional status, and inflammation [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]

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.

• Obesity
• Morbid Obesity

• No Intervention: Control arm
  Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
• Experimental: Treatment arm
  Medical food
  Intervention: Dietary Supplement: BariatrX Essentials 360 Treatment

Inclusion Criteria:

• Obese and morbidly obese women (BMI 30 - 50)
• 25 years and older undergoing laparoscopic gastric bypass surgery
• Present with at least either metabolic syndrome or diabetes

Exclusion Criteria:

• Have smoked in the past 4 weeks
• Pregnant
• Allergic or intolerant to ingredients used in the study (e.g. soy and THIAA)
• There is a sound medical, psychiatric and/or social reason as determined by the Principal Investigator (PI) that makes the subject unsuitable for the study