Recruiting

Nutritional Stimulation

Sponsor:

Oregon Health and Science University

Code:

NCT04751916

Conditions

Weight Loss

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

Interventions

Essential Amino Acid Protein Supplement

Beneprotein®

Study Details

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 nutritional formulation will maintain muscle mass while stimulating fat loss after bariatric surgery.

Conditions

Weight Loss

Study ID

NCT04751916

Start date

Mar 9, 2021

Status verified date

Mar, 2023

Completion date

Feb 28, 2024

Anticipated

Primary completion date

Feb 28, 2024

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18 - 60

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

40 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Proprietary Essential Amino Acid Protein Supplement

Essential amino acid protein supplement; 15 grams (one packet) dissolved in 8 ounces of water twice daily for 6 months.

active comparator: Commercially-available whey protein supplement - Beneprotein®

Beneprotein® whey protein supplement; 15 grams (one packet) dissolved in 8 ounces of water twice daily for 6 months.

Interventions

Essential Amino Acid Protein Supplement

Proprietary essential amino acid protein supplement

Beneprotein®

Whey protein supplement

Primary outcome measure

  • Lean body mass [ Time Frame: Baseline (before bariatric surgery) ]
  • Lean body mass [ Time Frame: 6 months after bariatric surgery ]
  • Total energy expenditure [ Time Frame: Baseline (before bariatric surgery) ]
  • Total energy expenditure [ Time Frame: 6 months after bariatric surgery ]
  • Muscle mass [ Time Frame: Baseline (before bariatric surgery) ]
  • Muscle mass [ Time Frame: 6 months after bariatric surgery ]

Central Contacts and Locations

Central contacts

Lauren P Martin, MS RD LD

(971)288-8487marlaure@ohsu.edu

Sarah D Livingston

(503)494-1322livingss@ohsu.edu

Locations

Oregon Health and Science University

Recruiting

Portland, Oregon, United States, 97239

Contacts

Nancy Puzziferri, MD

503-494-1322puzzifer@ohsu.edu

Lauren Martin, MS

5034941488marlaure@ohsu.edu

More Information

Sponsor

Oregon Health and Science University

Last update posted

Apr 4, 2023

Last verified

Mar, 2023

Keywords

  • bariatric surgery
  • muscle synthesis
  • weight loss
  • essential amino acids
  • protein supplementation
  • total energy expenditure

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Oregon Health and Science University on 2023-04-04.