Status:
UNKNOWN
Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric Surgery
Lead Sponsor:
Oregon Health and Science University
Collaborating Sponsors:
The Amino Company, LLC
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Weight Loss
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief Summary
Bariatric surgery is an effective treatment for severe obesity but results in loss of muscle mass. The investigators will test the hypothesis that consumption of an Essential Amino Acid-based nutritio...
Detailed Description
1. Objectives Bariatric surgery has become a common treatment for severe obesity, and results in a loss of fat mass. However, muscle mass is also lost following bariatric surgery. It is the invest...
Eligibility Criteria
Inclusion
- A determination to proceed with bariatric surgery
- Roux-en-Y gastric bypass or sleeve gastrectomy
- Absence of any exclusion
Exclusion
- Contraindications to Magnetic Resonance Spectroscopy/Magnetic Resonance Imaging
- greater than 450 pounds (scan table limit)
- Renal Failure requiring dialysis
- Liver disease as indicated by bilirubin \>2 or Fibrosis-4 score ≥6
- Cardiac disease such as Left Ventricular Assist Device requirement
- Uncontrolled diabetes as indicated by Hemoglobin A1c \>8
- Positive pregnancy test (for participants in whom pregnancy is possible)
- Any other exclusion per indication of clinical surgeon
- Refusal to consume study formula
Key Trial Info
Start Date :
March 9 2021
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
February 28 2024
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT04751916
Start Date
March 9 2021
End Date
February 28 2024
Last Update
April 4 2023
Active Locations (1)
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1
Oregon Health and Science University
Portland, Oregon, United States, 97239