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

Primary Purpose

Obesity, Morbid Obesity

Status

Terminated

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

BariatrX Essentials 360 Treatment

About this trial

This is an interventional supportive care trial for Obesity focused on measuring Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention

Eligibility Criteria

25 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

Boston Medical Center

Arms of the Study

Arm 1

Arm 2

Arm Type

No Intervention

Experimental

Arm Label

Control arm

Treatment arm

Arm Description

Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)

Medical food

Outcomes

Primary Outcome Measures

Total and extracellular water (by cold bromide and deuterium method)

Dual energy X-ray absorptiometry (DEXA)

Secondary Outcome Measures

Hair loss (by photographic method and Hair-Scalp Questionnaire)

Impedance plethysmography (by distal and proximal electrode placement)

Muscle strength (by a handgrip dynamometer)

Resting energy expenditure (by indirect calorimetry)

Pulse after a 6-minute walk

Measures of insulin resistance, visceral protein/nutritional status, and inflammation

Full Information

NCT ID

NCT01041261

First Posted

December 29, 2009

Last Updated

January 11, 2012

Sponsor

MetaProteomics LLC

Collaborators

Boston Medical Center

1. Study Identification

Unique Protocol Identification Number

NCT01041261

Brief Title

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

2. Study Status

Record Verification Date

January 2012

Overall Recruitment Status

Terminated

Study Start Date

September 2009 (undefined)

Primary Completion Date

January 2012 (Actual)

Study Completion Date

January 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

MetaProteomics LLC

Collaborators

Boston Medical Center

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Obesity, Morbid Obesity

Keywords

Laparoscopic gastric bypass surgery, Medical food, Body composition, Dietary intervention

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

7 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Control arm

Arm Type

No Intervention

Arm Description

Subjects will be issued control study product (Carnation Instant Breakfast, no sugar added)

Arm Title

Treatment arm

Arm Type

Experimental

Arm Description

Medical food

Intervention Type

Dietary Supplement

Intervention Name(s)

BariatrX Essentials 360 Treatment

Other Intervention Name(s)

BariatrX Essentials 360

Intervention Description

Medical food

Primary Outcome Measure Information:

Title

Total and extracellular water (by cold bromide and deuterium method)

Time Frame

Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery

Title

Dual energy X-ray absorptiometry (DEXA)

Time Frame

Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery

Secondary Outcome Measure Information:

Title

Hair loss (by photographic method and Hair-Scalp Questionnaire)

Time Frame

Baseline, 12 weeks, and 24 weeks

Title

Impedance plethysmography (by distal and proximal electrode placement)

Time Frame

Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Title

Muscle strength (by a handgrip dynamometer)

Time Frame

Baseline, 4weeks, 12 weeks, and 24 weeks

Title

Resting energy expenditure (by indirect calorimetry)

Time Frame

Baseline, 4 weeks, 12 weeks and 24 weeks

Title

Pulse after a 6-minute walk

Time Frame

Baseline, 4 weeks, 12 weeks, and 24 weeks

Title

Measures of insulin resistance, visceral protein/nutritional status, and inflammation

Time Frame

Baseline, 12 weeks, and 24 weeks

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Caroline Apovian, MD

Organizational Affiliation

Boston Medical Center

Official's Role

Principal Investigator

Facility Information:

Facility Name

Boston Medical Center

City

Boston

State/Province

Massachusetts

ZIP/Postal Code

02118

Country

United States

12. IPD Sharing Statement

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

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