Clinical trial NCT01041261: Effects of a Novel Dietary Intervention on Body Composition After Laparoscopic Gastric Bypass Surgery
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 type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Obesity
Morbid Obesity
Keywords: Laparoscopic gastric bypass surgery
Medical food
Body composition
Dietary intervention
Lead sponsor: MetaProteomics LLC
Sponsor class: INDUSTRY
Collaborators: name: Boston Medical Center
First posted: 2009-12-31
Enrollment: 7
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

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.

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 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

Primary outcomes:
measure: Total and extracellular water (by cold bromide and deuterium method)
timeFrame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
measure: Dual energy X-ray absorptiometry (DEXA)
timeFrame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery
Secondary outcomes:
measure: Hair loss (by photographic method and Hair-Scalp Questionnaire)
timeFrame: Baseline, 12 weeks, and 24 weeks
measure: Impedance plethysmography (by distal and proximal electrode placement)
timeFrame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks
measure: Muscle strength (by a handgrip dynamometer)
timeFrame: Baseline, 4weeks, 12 weeks, and 24 weeks
measure: Resting energy expenditure (by indirect calorimetry)
timeFrame: Baseline, 4 weeks, 12 weeks and 24 weeks
measure: Pulse after a 6-minute walk
timeFrame: Baseline, 4 weeks, 12 weeks, and 24 weeks
measure: Measures of insulin resistance, visceral protein/nutritional status, and inflammation
timeFrame: Baseline, 12 weeks, and 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Boston Medical Center
state: Massachusetts
Study officials:
affiliation: Boston Medical Center
name: Caroline Apovian, MD
role: PRINCIPAL_INVESTIGATOR
References: