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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
History of Changes
  Purpose

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 Intervention
Obesity
Morbid Obesity
 Dietary Supplement: BariatrX Essentials 360 Treatment

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: 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

Resource links provided by NLM:

MedlinePlus related topics: Obesity
U.S. FDA Resources

Further study details as provided by MetaProteomics LLC:

Primary Outcome Measures:
  • 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 ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 7
Study Start Date: September 2009
Study Completion Date: January 2012
Primary Completion Date: January 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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.

  Eligibility

Ages Eligible for Study:   25 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01041261

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

No publications provided

Responsible Party: MetaProteomics LLC
ClinicalTrials.gov Identifier: NCT01041261     History of Changes
Other Study ID Numbers: BAR1-BMC-CT
Study First Received: December 29, 2009
Last Updated: January 11, 2012
Health Authority: United States: Institutional Review Board

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

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

ClinicalTrials.gov processed this record on May 21, 2013