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
1 other identifier
interventional
7
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable obesity
Started Sep 2009
Typical duration for not_applicable obesity
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2009
CompletedFirst Submitted
Initial submission to the registry
December 29, 2009
CompletedFirst Posted
Study publicly available on registry
December 31, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2012
CompletedStudy Completion
Last participant's last visit for all outcomes
January 1, 2012
CompletedJanuary 13, 2012
January 1, 2012
2.3 years
December 29, 2009
January 11, 2012
Conditions
Keywords
Outcome Measures
Primary Outcomes (2)
Total and extracellular water (by cold bromide and deuterium method)
Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Dual energy X-ray absorptiometry (DEXA)
Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Secondary Outcomes (6)
Hair loss (by photographic method and Hair-Scalp Questionnaire)
Baseline, 12 weeks, and 24 weeks
Impedance plethysmography (by distal and proximal electrode placement)
Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
Muscle strength (by a handgrip dynamometer)
Baseline, 4weeks, 12 weeks, and 24 weeks
Resting energy expenditure (by indirect calorimetry)
Baseline, 4 weeks, 12 weeks and 24 weeks
Pulse after a 6-minute walk
Baseline, 4 weeks, 12 weeks, and 24 weeks
- +1 more secondary outcomes
Study Arms (2)
Control arm
NO INTERVENTIONSubjects will be issued control study product (Carnation Instant Breakfast, no sugar added)
Treatment arm
EXPERIMENTALMedical food
Interventions
Medical food
Eligibility Criteria
You may qualify if:
- Obese and morbidly obese women (BMI 30 - 50)
- years and older undergoing laparoscopic gastric bypass surgery
- Present with at least either metabolic syndrome or diabetes
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- MetaProteomics LLClead
- Boston Medical Centercollaborator
Study Sites (1)
Boston Medical Center
Boston, Massachusetts, 02118, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Caroline Apovian, MD
Boston Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- SUPPORTIVE CARE
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 29, 2009
First Posted
December 31, 2009
Study Start
September 1, 2009
Primary Completion
January 1, 2012
Study Completion
January 1, 2012
Last Updated
January 13, 2012
Record last verified: 2012-01