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

NCT ID: NCT01041261

Last Updated: 2012-01-13

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 7 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-01-31

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.

Conditions

Obesity; Morbid Obesity

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: NONE

Study Groups

Control arm

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

Group Type: NO_INTERVENTION

No interventions assigned to this group

Treatment arm

Medical food

Group Type: EXPERIMENTAL

BariatrX Essentials 360 Treatment

Intervention Type: DIETARY_SUPPLEMENT

Medical food

Interventions

BariatrX Essentials 360 Treatment

Medical food

Intervention Type: DIETARY_SUPPLEMENT

Other Intervention Names

BariatrX Essentials 360

Eligibility Criteria

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

• Minimum Eligible Age: 25 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Boston Medical Center

OTHER

Sponsor Role: collaborator

MetaProteomics LLC

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Caroline Apovian, MD

Role: PRINCIPAL_INVESTIGATOR

Boston Medical Center

Locations

Boston Medical Center

Boston, Massachusetts, United States

Countries

United States

Other Identifiers

BAR1-BMC-CT

Identifier Type: -

Identifier Source: org_study_id