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Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric Surgery
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 nutritional formulation will maintain muscle mass while stimulating fat loss after bariatric surgery.
Conditions:
🦠 Weight Loss
🗓️ Study Start (Actual) 9 March 2021
🗓️ Primary Completion (Estimated) 28 February 2024
✅ Study Completion (Estimated) 28 February 2024
👥 Enrollment (Estimated) 40
🔬 Study Type INTERVENTIONAL
📊 Phase NA
Locations:
📍 Portland, Oregon, United States

📋 Eligibility Criteria

Description

    Inclusion Criteria:

    • * A determination to proceed with bariatric surgery
    • * Roux-en-Y gastric bypass or sleeve gastrectomy
    • * Absence of any exclusion

    Exclusion Criteria:

    • * 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
Ages Eligible for Study: 18 Years to 60 Years (ADULT)
Sexes Eligible for Study: ALL
Accepts Healthy Volunteers: No

🗓️ Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

  • First Submitted 2 February 2021
  • First Submitted that Met QC Criteria 9 February 2021
  • First Posted 12 February 2021

Study Record Updates

  • Last Update Submitted that Met QC Criteria 31 March 2023
  • Last Update Posted 4 April 2023
  • Last Verified March 2023
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