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

MetaProteomics LLC7 enrolled

Overview

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.

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 Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Obesity Morbid Obesity

Interventions

BariatrX Essentials 360 TreatmentDIETARY_SUPPLEMENT

Medical food

Eligibility

Sex: FEMALEMin age: 25 Years

Medical Language ↔ Plain English

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

Locations (1)

Boston Medical Center

Boston, Massachusetts, United States

Outcomes

Primary Outcomes

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

Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery

Dual energy X-ray absorptiometry (DEXA)

Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks post surgery

Secondary Outcomes

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

Time frame: Baseline, 12 weeks, and 24 weeks

Impedance plethysmography (by distal and proximal electrode placement)

Time frame: Baseline, 4 weeks, 8 weeks, 12 weeks, and 24 weeks

Muscle strength (by a handgrip dynamometer)

Time frame: Baseline, 4weeks, 12 weeks, and 24 weeks

Resting energy expenditure (by indirect calorimetry)

Time frame: Baseline, 4 weeks, 12 weeks and 24 weeks

Pulse after a 6-minute walk

Time frame: Baseline, 4 weeks, 12 weeks, and 24 weeks

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

Time frame: Baseline, 12 weeks, and 24 weeks

Data from ClinicalTrials.gov

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