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

MetaProteomics

Status: Terminated

Conditions: Obesity; Morbid Obesity

Treatments: Dietary Supplement: BariatrX Essentials 360 Treatment

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT01041261

BAR1-BMC-CT

Details and patient eligibility

About

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.

Full 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.

Enrollment: 7 patients

Sex: Female

Ages: 25+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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7 participants in 2 patient groups

Control arm

No Intervention group

Description:

Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)

Treatment arm

Experimental group

Description:

Medical food

Treatment:

Dietary Supplement: BariatrX Essentials 360 Treatment