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

Not Applicable

Terminated

• Conditions: Obesity; Morbid Obesity

• Registration Number: NCT01041261
• Lead Sponsor: MetaProteomics LLC

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.

Study Timeline

• Study Start: 2009-09
• Study First Submitted: 2009-12-29
• Study First Submitted QC: 2009-12-30
• Study First Posted: 2009-12-31
• Status Verified: 2012-01
• Primary Completion: 2012-01
• Study Completion: 2012-01
• Last Update Submitted: 2012-01-11
• Last Update Posted: 2012-01-13

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 7

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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
Measures of insulin resistance, visceral protein/nutritional status, and inflammation	Baseline, 12 weeks, and 24 weeks

Trial Locations

Locations (1)

Boston Medical Center; 🇺🇸 Boston, Massachusetts, United States