Morbid Obesity, Obesity
Conditions
Keywords
Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention
Brief summary
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
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.
Interventions
DIETARY_SUPPLEMENTBariatrX Essentials 360 Treatment
Medical food
Sponsors
Boston Medical Center
MetaProteomics LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
25 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | 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
| Measure | Time frame |
|---|---|
| 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 |
| Hair loss (by photographic method and Hair-Scalp Questionnaire) | Baseline, 12 weeks, and 24 weeks |
| Measures of insulin resistance, visceral protein/nutritional status, and inflammation | Baseline, 12 weeks, and 24 weeks |
| Pulse after a 6-minute walk | Baseline, 4 weeks, 12 weeks, and 24 weeks |
| Impedance plethysmography (by distal and proximal electrode placement) | Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks |
Countries
United States
Outcome results
None listed