Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric Surgery

NCT04751916 | Unknown DMC

• 2 other identifiers: 1R44DK125151-000212101R44DK125151
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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

Keywords

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

Outcome Measures

Primary Outcomes (6)

• Lean body mass

  Lean body mass in kilograms

  Baseline (before bariatric surgery)

• Lean body mass

  Lean body mass in kilograms

  6 months after bariatric surgery

• Total energy expenditure

  Total energy expenditure in kilocalories per day

  Baseline (before bariatric surgery)

• Total energy expenditure

  Total energy expenditure in kilocalories per day

  6 months after bariatric surgery

• Muscle mass

  Muscle mass in kilograms

  Baseline (before bariatric surgery)

• Muscle mass

  Muscle mass in kilograms

  6 months after bariatric surgery

Secondary Outcomes (30)

• Liver fat mass

  Baseline (before bariatric surgery)

• Liver fat mass

  6 months after bariatric surgery

• Visceral fat mass

  Baseline (before bariatric surgery)

• Visceral fat mass

  6 months after bariatric surgery

• Subcutaneous fat mass

  Baseline (before bariatric surgery)

Other Outcomes (14)

• Physical activity (Subjective)

  Baseline (before bariatric surgery)

• Physical activity (Subjective)

  1 month after bariatric surgery

• Physical activity (Subjective)

  2 months after bariatric surgery

Study Arms (2)

Proprietary Essential Amino Acid Protein Supplement

EXPERIMENTAL

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

Dietary Supplement: Essential Amino Acid Protein Supplement

Commercially-available whey protein supplement - Beneprotein®

ACTIVE COMPARATOR

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

Dietary Supplement: Beneprotein®

Interventions

Essential Amino Acid Protein Supplement DIETARY_SUPPLEMENT

Proprietary essential amino acid protein supplement

Proprietary Essential Amino Acid Protein Supplement

Beneprotein® DIETARY_SUPPLEMENT

Whey protein supplement

Commercially-available whey protein supplement - Beneprotein®

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• A determination to proceed with bariatric surgery
• Roux-en-Y gastric bypass or sleeve gastrectomy

You may not qualify if:

• 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)
• Refusal to consume study formula

Sponsors & Collaborators

• Oregon Health and Science University: lead
• The Amino Company, LLC: collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Oregon Health and Science University

Portland, Oregon, 97239, United States

RECRUITING

Related Publications (24)

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MeSH Terms

Conditions

Weight Loss

Condition Hierarchy (Ancestors)

Body Weight Changes; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Nancy Puzziferri, MD MSCS

  Oregon Health and Science University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Lauren P Martin, MS RD LD

CONTACT

(971)288-8487; marlaure@ohsu.edu

Sarah D Livingston

CONTACT

(503)494-1322; livingss@ohsu.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: After obtaining consent, the patient will receive supplement assignment based on computer-generated, block-randomization with stratification by sex. The intervention and control supplements are packaged, sealed and labeled as group A or B by The Amino Co. The packets are sent to Oregon Health \& Science University at study start and stored at room temperature in the investigators' laboratory. The Oregon Health \& Science University investigators are unaware of which supplements are packaged as group A or B. The research coordinator is responsible for completing the randomization process using a table created by the statistician. The stratification/randomization assignments are kept in a password-protected file; the password known only to the research coordinator and statistician. The powdered and reconstituted forms of the supplements are indistinguishable to an observer.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor of Surgery

Model Details: double-blinded randomized clinical trial

Study Record Dates

• First Submitted: February 2, 2021
• First Posted: February 12, 2021
• Study Start: March 9, 2021
• Primary Completion: February 28, 2024
• Study Completion: February 28, 2024
• Last Updated: April 4, 2023

Record last verified: 2023-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Immediately following publication without an access end date.
• Access Criteria: Any person. Any purpose.

Locations

US (1)