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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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

Conditions
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Obesity, Morbid Obesity

Intervention / Treatment
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* Dietary Supplement: BariatrX Essentials 360 Treatment


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 25 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Supportive Care
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control arm<br>Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added) | |
| Experimental: Treatment arm<br>Medical food | Dietary Supplement: BariatrX Essentials 360 Treatment<br>* Medical food<br>* Other names: BariatrX Essentials 360;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Total and extracellular water (by cold bromide and deuterium method) |  | Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery | 
| Dual energy X-ray absorptiometry (DEXA) |  | Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Hair loss (by photographic method and Hair-Scalp Questionnaire) |  | Baseline, 12 weeks, and 24 weeks | 
| Impedance plethysmography (by distal and proximal electrode placement) |  | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks | 
| Muscle strength (by a handgrip dynamometer) |  | Baseline, 4weeks, 12 weeks, and 24 weeks | 
| Resting energy expenditure (by indirect calorimetry) |  | Baseline, 4 weeks, 12 weeks and 24 weeks | 
| Pulse after a 6-minute walk |  | Baseline, 4 weeks, 12 weeks, and 24 weeks | 
| Measures of insulin resistance, visceral protein/nutritional status, and inflammation |  | Baseline, 12 weeks, and 24 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention