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

January 11, 2012 updated by: MetaProteomics LLC

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

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 Overview

Status

Terminated

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Actual)

7

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02118
        • Boston Medical Center

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

25 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: Control arm
Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
Experimental: Treatment arm
Medical food
Dietary supplement: BariatrX Essentials 360 Treatment
Medical food
Other Names:
  • BariatrX Essentials 360

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

MetaProteomics LLC

Collaborators

Boston Medical Center

Investigators

  • Principal Investigator: Caroline Apovian, MD, Boston Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

September 1, 2009

Primary Completion (Actual)

January 1, 2012

Study Completion (Actual)

January 1, 2012

Study Registration Dates

First Submitted

December 29, 2009

First Submitted That Met QC Criteria

December 30, 2009

First Posted (Estimate)

December 31, 2009

Study Record Updates

Last Update Posted (Estimate)

January 13, 2012

Last Update Submitted That Met QC Criteria

January 11, 2012

Last Verified

January 1, 2012

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BAR1-BMC-CT

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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