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

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ClinicalTrials.gov Identifier: NCT01041261
Recruitment Status : Terminated
First Posted : December 31, 2009
Last Update Posted : January 13, 2012
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Obesity Morbid Obesity Dietary Supplement: BariatrX Essentials 360 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 Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 7 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: 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
Study Start Date : September 2009
Primary Completion Date : January 2012
Study Completion Date : January 2012
Arms and Interventions

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 Name: BariatrX Essentials 360

Outcome Measures

Primary Outcome Measures :
  1. Total and extracellular water (by cold bromide and deuterium method) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ]
  2. Dual energy X-ray absorptiometry (DEXA) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ]

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

Eligibility Criteria

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Ages Eligible for Study:   25 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts 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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01041261

United States, Massachusetts
Boston Medical Center
Boston, Massachusetts, United States, 02118
Sponsors and Collaborators
MetaProteomics LLC
Boston Medical Center
Principal Investigator: Caroline Apovian, MD Boston Medical Center
More Information

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01041261     History of Changes
Other Study ID Numbers: BAR1-BMC-CT
First Posted: December 31, 2009    Key Record Dates
Last Update Posted: January 13, 2012
Last Verified: January 2012

Keywords provided by MetaProteomics LLC:
Laparoscopic gastric bypass surgery
Medical food
Body composition
Dietary intervention

Additional relevant MeSH terms:
Obesity, Morbid
Nutrition Disorders
Body Weight
Signs and Symptoms