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

This study has been terminated.
Sponsor:
Collaborator:
Boston Medical Center
Information provided by (Responsible Party):
MetaProteomics LLC
ClinicalTrials.gov Identifier:
NCT01041261
First received: December 29, 2009
Last updated: January 11, 2012
Last verified: January 2012

December 29, 2009
January 11, 2012
September 2009
January 2012   (final data collection date for primary outcome measure)
  • Total and extracellular water (by cold bromide and deuterium method) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ] [ Designated as safety issue: No ]
  • Dual energy X-ray absorptiometry (DEXA) [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT01041261 on ClinicalTrials.gov Archive Site
  • Hair loss (by photographic method and Hair-Scalp Questionnaire) [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Impedance plethysmography (by distal and proximal electrode placement) [ Time Frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Muscle strength (by a handgrip dynamometer) [ Time Frame: Baseline, 4weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Resting energy expenditure (by indirect calorimetry) [ Time Frame: Baseline, 4 weeks, 12 weeks and 24 weeks ] [ Designated as safety issue: No ]
  • Pulse after a 6-minute walk [ Time Frame: Baseline, 4 weeks, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
  • Measures of insulin resistance, visceral protein/nutritional status, and inflammation [ Time Frame: Baseline, 12 weeks, and 24 weeks ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
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 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.

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
  • Obesity
  • Morbid Obesity
Dietary Supplement: BariatrX Essentials 360 Treatment
Medical food
Other Name: BariatrX Essentials 360
  • No Intervention: Control arm
    Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
  • Experimental: Treatment arm
    Medical food
    Intervention: Dietary Supplement: BariatrX Essentials 360 Treatment
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Terminated
7
January 2012
January 2012   (final data collection date for primary outcome measure)

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
Female
25 Years and older
No
Contact information is only displayed when the study is recruiting subjects
United States
 
NCT01041261
BAR1-BMC-CT
No
MetaProteomics LLC
MetaProteomics LLC
Boston Medical Center
Principal Investigator: Caroline Apovian, MD Boston Medical Center
MetaProteomics LLC
January 2012

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP