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

Obesity Clinical Trial

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT01041261
• Other study ID #: BAR1-BMC-CT
• Status: Terminated
• Phase: N/A
• First received: December 29, 2009
• Last updated: January 11, 2012
• Start date: September 2009
• Est. completion date: January 2012

Study information

• Verified date: January 2012
• Source: MetaProteomics LLC
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 7
• Est. completion date: January 2012
• Est. primary completion date: January 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Morbid Obesity
• Obesity
• Obesity, Morbid

Intervention

Dietary Supplement:
• BariatrX Essentials 360 Treatment
Medical food

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
MetaProteomics LLC	Boston Medical Center

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Total and extracellular water (by cold bromide and deuterium method)		Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery	No
Primary	Dual energy X-ray absorptiometry (DEXA)		Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery	No
Secondary	Hair loss (by photographic method and Hair-Scalp Questionnaire)		Baseline, 12 weeks, and 24 weeks	No
Secondary	Impedance plethysmography (by distal and proximal electrode placement)		Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks	No
Secondary	Muscle strength (by a handgrip dynamometer)		Baseline, 4weeks, 12 weeks, and 24 weeks	No
Secondary	Resting energy expenditure (by indirect calorimetry)		Baseline, 4 weeks, 12 weeks and 24 weeks	No
Secondary	Pulse after a 6-minute walk		Baseline, 4 weeks, 12 weeks, and 24 weeks	No
Secondary	Measures of insulin resistance, visceral protein/nutritional status, and inflammation		Baseline, 12 weeks, and 24 weeks	No