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

• ClinicalTrials.gov Identifier: NCT04751916
• Recruitment Status: Recruiting
• First Posted: February 12, 2021
• Last Update Posted: February 7, 2022
• Sponsor: Oregon Health and Science University
• Collaborators: The Amino Company, LLC; National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
• Information provided by (Responsible Party): Nancy Puzziferri, Oregon Health and Science University

Study Description

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.

Condition or disease	Intervention/treatment	Phase
Weight Loss	Dietary Supplement: Essential Amino Acid Protein Supplement; Dietary Supplement: Beneprotein®	Not Applicable

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 investigators' overarching premise that consumption of the Essential Amino Acid-based nutritional formulation following bariatric surgery will preserve muscle mass by stimulating muscle protein synthesis. As a result, the energy utilization associated with the combination of maintained muscle mass and stimulated muscle protein synthesis will counter the decrease in metabolic rate that normally occurs in hypocaloric circumstances. Maintenance of a higher total energy expenditure by Essential Amino Acid consumption will accelerate loss of body fat, as well as accelerate loss of body weight. The investigators further propose that consumption of an Essential Amino Acid-based nutritional formulation will reduce muscle intra-cellular lipid accumulation, which will translate to greater improvements in glucose homeostasis and muscle protein metabolism. The loss of muscle mass in those with obesity undergoing rapid weight loss post-bariatric surgery, is not in itself, a disease or a medical condition.

   The following aims will test specific hypotheses related to the scientific premise:

   Aim 1. Supplementation of the usual diet following bariatric surgery with a proprietary Essential Amino Acid-based nutritional formulation twice per day for 6 months will maintain muscle mass and reduce fat mass more than supplementation of the diet with an isonitrogenous amount of whey protein. Muscle mass will be directly measured using a novel tracer-dilution technique using deuterium-labeled creatine. Fat mass and lean body mass will be measured by Dual-energy X-ray absorptiometry.

   Aim 2. Muscle protein fractional synthetic rate and total muscle protein synthesis (muscle mass x fractional synthetic rate) will decline less from pre-surgery values in participants consuming the Essential Amino Acid-based nutritional formulation as compared to whey protein. Muscle protein fractional synthetic rate will be measured by the novel "virtual biopsy" method, which provides an integrated value over three weeks.

   Aim 3. The pre-surgery rate of total energy expenditure will be better maintained in participants consuming the Essential Amino Acid-based nutritional formulation as opposed to whey protein. Change in total energy expenditure will be measured over 10-day intervals using the doubly-labeled water technique, before to 6 months following surgery.

   Aim 4. Six months after bariatric surgery muscle intra-cellular lipid accumulation will be reduced from the pre-surgery value to a greater extent in participants consuming the Essential Amino Acid-based nutritional formulation than whey protein. Muscle intra-cellular lipid accumulation will be measured by means of magnetic resonance spectroscopy and magnetic resonance imaging. The investigators anticipate that a greater reduction in intra-cellular lipid accumulation will be related to greater improvement in insulin sensitivity in terms of glucose homeostasis and also in terms of muscle protein synthesis.

   Positive results of this study will support the value of the Essential Amino Acid-based nutritional formulation in terms of increasing the rate of fat loss and improving body composition changes following bariatric surgery.

2. Background

   Despite successful weight loss and improvement of comorbidities after bariatric surgery, most patients with severe obesity remain overweight. Patients also experience variation in treatment response. Up to 30% patients experience sub-optimal weight loss or significant weight regain. Amount of weight lost and its maintenance are important because they are what lead to improvement/remission of comorbidities (diabetes, heart disease, etc.), and to decreased mortality from cardiovascular disease or cancer. One of the keys to optimal weight loss from a calorie restricted diet, and subsequent weight-loss maintenance, is losing fat without losing muscle (aka lean body mass). It is decreased energy expenditure from decreased muscle mass after weight loss which contributes significantly to weight regain. Muscle mass is the key driver of energy metabolism favoring the burning of food as fuel rather than its storage as fat. Since muscle provides a reservoir of amino acids to maintain protein synthesis essential for survival, its mass quantity is always at risk under conditions of inadequate dietary intake. Skeletal muscle, under the caloric restriction of weight-loss diets, catabolizes to provide the body's unmet protein needs. It becomes challenging to maintain muscle in conditions of severe calorie restriction such as after bariatric surgery.

   Protein supplementation has been shown to protect against muscle loss experienced in weight loss, but only if supplementation is sufficient. The standard of care approach to maintain muscle mass during rapid, significant weight loss after bariatric surgery has been dietary whey protein supplementation. After bariatric surgery, protein supplementation is limited by the inability of patients to take in sufficient calories. This can be further hindered by typical perioperative complications which limit intake, such as nausea, vomiting, and early satiety. Therefore, despite standard of care supplementation with whey protein post bariatric surgery, only marginal gains in preventing muscle loss have been made. Essential Amino Acid, the intervention supplement in this study, is a patented formula scientifically shown to be far more anabolic than whey protein in free-living elderly and young healthy adults undergoing bedrest. The Essential Amino Acid supplement stimulates protein synthesis 3-5 times as effectively as whey protein, with negligible non-protein calories.

   The importance of the role of muscle in weight loss and its maintenance cannot be overemphasized. Muscle, crucial to energy metabolism, is responsible for the majority of total energy expenditure (equivalent to physical activity energy expenditure, resting energy expenditure, and diet induced thermogenesis - calories required to digest food). Both physical activity, and muscle protein synthesis comprise a significant portion of energy expenditure. Through its function in physical activity and protein synthesis, muscle largely determines the caloric expenditure underlying the ability to 'use up' food eaten rather than store it as fat.

   Obesity, is not just increased body fat, but also increased intramuscular fat. The intramuscular fat associated with obesity impairs the muscle function of providing normal glucose homeostasis. Fortunately, when fat stored in muscle decreases, insulin sensitivity improves. Also impaired under conditions of increased intramuscular fat, is the function of providing amino acids to maintain essential protein synthesis. Impaired muscle mitochondria-stimulated protein synthesis potentially decreases resting energy expenditure, and diet induced thermogenesis. Adequate protein supplementation can counter muscle mitochondrial protein synthesis impairment, and in theory, lead to decreased intramuscular fat improving both energy expenditure and insulin sensitivity.

3. Study Design

This is a double-blinded randomized clinical trial in which the responses to consumption of one of two different dietary supplements following bariatric surgery will be determined. A variety of factors related to body composition and muscle metabolism will be quantified in participants with obesity before and approximately 6 months after bariatric surgery. This interval of time was selected because additional body weight changes are generally relatively small 6 months after surgery; most of the weight loss occurs in the first 6 months. Participants will be assigned randomly by computer to receive either an Essential Amino Acid based nutritional supplement (intervention) or a commercially-available whey protein supplement (Beneprotein®).

Study Design

• Study Type: Interventional (Clinical Trial)
• Estimated Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Intervention Model Description: double-blinded randomized clinical trial
• Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
• Masking Description: 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.
• Primary Purpose: Treatment
• Official Title: Nutritional Stimulation of Muscle Protein Synthesis and Metabolic Rate After Bariatric Surgery
• Actual Study Start Date: March 9, 2021
• Estimated Primary Completion Date: August 15, 2022
• Estimated Study Completion Date: October 17, 2022

Arms and Interventions

Arm	Intervention/treatment
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.	Dietary Supplement: Essential Amino Acid Protein Supplement; Proprietary essential amino acid protein supplement
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.	Dietary Supplement: Beneprotein®; Whey protein supplement

Outcome Measures

Primary Outcome Measures :

1. Lean body mass [ Time Frame: Baseline (before bariatric surgery) ]
   Lean body mass in kilograms
2. Lean body mass [ Time Frame: 6 months after bariatric surgery ]
   Lean body mass in kilograms
3. Total energy expenditure [ Time Frame: Baseline (before bariatric surgery) ]
   Total energy expenditure in kilocalories per day
4. Total energy expenditure [ Time Frame: 6 months after bariatric surgery ]
   Total energy expenditure in kilocalories per day
5. Muscle mass [ Time Frame: Baseline (before bariatric surgery) ]
   Muscle mass in kilograms
6. Muscle mass [ Time Frame: 6 months after bariatric surgery ]
   Muscle mass in kilograms

Secondary Outcome Measures :

1. Liver fat mass [ Time Frame: Baseline (before bariatric surgery) ]
   Liver fat mass in kilograms
2. Liver fat mass [ Time Frame: 6 months after bariatric surgery ]
   Liver fat mass in kilograms
3. Visceral fat mass [ Time Frame: Baseline (before bariatric surgery) ]
   Visceral fat mass in kilograms
4. Visceral fat mass [ Time Frame: 6 months after bariatric surgery ]
   Visceral fat mass in kilograms
5. Subcutaneous fat mass [ Time Frame: Baseline (before bariatric surgery) ]
   Subcutaneous fat mass in kilograms
6. Subcutaneous fat mass [ Time Frame: 6 months after bariatric surgery ]
   Subcutaneous fat mass in kilograms
7. Whole body fat mass [ Time Frame: Baseline (before bariatric surgery) ]
   Whole body fat mass in kilograms
8. Whole body fat mass [ Time Frame: 6 months after bariatric surgery ]
   Whole body fat mass in kilograms
9. Weight [ Time Frame: Baseline (before bariatric surgery) ]
   Weight in kilograms
10. Weight [ Time Frame: 6 months after bariatric surgery ]
    Weight in kilograms
11. Resting energy expenditure [ Time Frame: Baseline (before bariatric surgery) ]
    Resting energy expenditure in kilocalories per day
12. Resting energy expenditure [ Time Frame: 6 months after bariatric surgery ]
    Resting energy expenditure in kilocalories per day
13. Diet induced thermogenesis [ Time Frame: Baseline (before bariatric surgery) ]
    Percent kilocalories expended to digest a kilocalorie of protein
14. Diet induced thermogenesis [ Time Frame: 6 months after bariatric surgery ]
    Percent kilocalories expended to digest a kilocalorie of protein
15. Glucose [ Time Frame: Baseline (before bariatric surgery) ]
    Blood plasma glucose in milligrams per deciliter
16. Glucose [ Time Frame: 6 months after bariatric surgery ]
    Blood plasma glucose in milligrams per deciliter
17. Insulin [ Time Frame: Baseline (before bariatric surgery) ]
    Blood serum insulin in micro-international units per milliliter
18. Insulin [ Time Frame: 6 months after bariatric surgery ]
    Blood serum insulin in micro-international units per milliliter
19. Essential amino acids [ Time Frame: Baseline (before bariatric surgery) ]
    Blood plasma essential amino acids in micromoles per liter
20. Essential amino acids [ Time Frame: 6 months after bariatric surgery ]
    Blood plasma essential amino acids in micromoles per liter
21. Dietary intake (Objective) [ Time Frame: Baseline (before bariatric surgery) ]
    Dietary record of intake in kilocalories per day for 3 days
22. Dietary intake (Objective) [ Time Frame: 6 months after bariatric surgery ]
    Dietary record of intake in kilocalories per day for 3 days
23. Physical activity (Objective) [ Time Frame: Baseline (before bariatric surgery) ]
    Physical activity by accelerometer kilocalories per day for 7 days
24. Physical activity (Objective) [ Time Frame: 6 months after bariatric surgery ]
    Physical activity by accelerometer kilocalories per day for 7 days
25. Percent muscle fat [ Time Frame: Baseline (before bariatric surgery) ]
    Muscle fat in kilogram percent
26. Percent muscle fat [ Time Frame: 6 months after bariatric surgery ]
    Muscle fat in kilogram percent
27. Muscle protein synthetic rate [ Time Frame: Baseline (before bariatric surgery) ]
    Muscle protein synthetic rate in kilograms per day
28. Muscle protein synthetic rate [ Time Frame: 6 months after bariatric surgery ]
    Muscle protein synthetic rate in kilograms per day
29. Muscle protein fractional synthetic rate [ Time Frame: Baseline (before bariatric surgery) ]
    Muscle protein fractional synthetic rate in kilogram percent per day
30. Muscle protein fractional synthetic rate [ Time Frame: 6 months after bariatric surgery ]
    Muscle protein fractional synthetic rate in kilogram percent per day

Other Outcome Measures:

1. Physical activity (Subjective) [ Time Frame: Baseline (before bariatric surgery) ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
2. Physical activity (Subjective) [ Time Frame: 1 month after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
3. Physical activity (Subjective) [ Time Frame: 2 months after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
4. Physical activity (Subjective) [ Time Frame: 3 months after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
5. Physical activity (Subjective) [ Time Frame: 4 months after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
6. Physical activity (Subjective) [ Time Frame: 5 months after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
7. Physical activity (Subjective) [ Time Frame: 6 months after bariatric surgery ]
   Physical activity by self-report completion of the International Physical Activity Questionnaire
8. Dietary Intake (Subjective) [ Time Frame: Baseline (before bariatric surgery) ]
   24-hour dietary recall collected by clinician
9. Dietary Intake (Subjective) [ Time Frame: 1 month after bariatric surgery ]
   24-hour dietary recall collected by clinician
10. Dietary Intake (Subjective) [ Time Frame: 2 months after bariatric surgery ]
    24-hour dietary recall collected by clinician
11. Dietary Intake (Subjective) [ Time Frame: 3 months after bariatric surgery ]
    24-hour dietary recall collected by clinician
12. Dietary Intake (Subjective) [ Time Frame: 4 months after bariatric surgery ]
    24-hour dietary recall collected by clinician
13. Dietary Intake (Subjective) [ Time Frame: 5 months after bariatric surgery ]
    24-hour dietary recall collected by clinician
14. Dietary Intake (Subjective) [ Time Frame: 6 months after bariatric surgery ]
    24-hour dietary recall collected by clinician

Eligibility Criteria

• Ages Eligible for Study: 18 Years to 60 Years (Adult)
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Criteria

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

Contacts and Locations

Contacts

Contact: Lauren P Martin, MS RD LD; (971)288-8487; marlaure@ohsu.edu

Contact: Sarah D Livingston; (503)494-1322; livingss@ohsu.edu

Locations

United States, Oregon

Oregon Health and Science University; Recruiting

Portland, Oregon, United States, 97239

Contact: Nancy Puzziferri, MD 503-494-1322 puzzifer@ohsu.edu

Contact: Lauren Martin, MS 5034941488 marlaure@ohsu.edu

Sponsors and Collaborators

Oregon Health and Science University

The Amino Company, LLC

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Investigators

• Principal Investigator: Nancy Puzziferri, MD MSCS; Oregon Health and Science University

More Information

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• Responsible Party: Nancy Puzziferri, Assistant Professor of Surgery, Oregon Health and Science University
• ClinicalTrials.gov Identifier: NCT04751916
• Other Study ID Numbers: 1R44DK125151-00021210; 1R44DK125151 ( U.S. NIH Grant/Contract )
• First Posted: February 12, 2021
• Last Update Posted: February 7, 2022
• Last Verified: February 2022

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: Yes
• Plan Description: Individual participant data (and data dictionaries) for this study will be available once fully collected and de-identified. The study protocol, statistical analysis plan, informed consent form, and clinical study reports will also be available. Data will be available immediately following publication without an access end date. Anyone may access the data, for any purpose. Data will be available indefinitely at a link to be provided at study completion.
• Supporting Materials: Study Protocol; Statistical Analysis Plan (SAP); Informed Consent Form (ICF); Clinical Study Report (CSR)
• Time Frame: Immediately following publication without an access end date.
• Access Criteria: Any person. Any purpose.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Nancy Puzziferri, Oregon Health and Science University:

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

Additional relevant MeSH terms:

Weight Loss; Body Weight Changes; Body Weight