Effects of Nutritional Preconditioning on the Patient's Outcomes After Surgery

Study Overview
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Brief Summary
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Malnutrition is a serious problem in patients undergoing major surgeries and has a direct association with increased morbidity, mortality, length of stay (LOS), increased readmissions and cost of care. Studies suggest several advantages of supplementation with protein or specific amino acids in malnourished patients. Dietary leucine or its metabolite β-hydroxy β-methylbutyrate (HMB) can improve skeletal muscle mass and function by increasing transcriptional level of protein synthase, while other high protein or amino acids like Glutamine or Arginine supplements only provide protein-amino acids pool for patients while body's preferred fuel during metabolic stress is endogens protein, rather than exogenous diet. In this study the investigators seek to achieve two distinct goals: Determine the patients' nutritional status before and after major surgeries by baseline and subsequent nutritional assessments, according to ASPEN's criteria. In addition, the investigators were going to use indirect calorimetry to determine the Resting Energy Expenditure (REE) in different phases of pre- and postoperative periods. The investigators also propose to compare different serum protein markers and their ratios in order to correlate them with ASPEN's criteria for nutritional status quantification. In Summary, three discrete tools including ASPEN's criteria, indirect calorimetry, and serum biomarkers are going to be used in conjunction with each other to delineate the patients' nutritional status in various pre- and post-operative periods. Patients undergoing major surgeries were supplemented with high protein with ß-hydroxy ß-methylbutyrate (HMB) (Ensure, Envile) or HMB only as a control, in order to improve their nutritional status and improve postoperative outcomes. The investigators looked for depict meaningful improvements in surgical outcomes by nutritional supplementation with or without HMB.

Detailed Description
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Hypotheses: We hypothesize that patients receiving high protein nutritional supplementation with HMB (Ensure Enlive) will have meaningful improvements in surgical outcomes rather than if they receive HMB only. Also, by comparing different methods of malnutrition designation, we are hypothesizing that by conduction this study, we will have a better understanding of malnutrition and its consequences in the Central Valley of California. Furthermore, we are planning to improve patient outcomes and significantly reduce the health care costs of the Valley by proper nutritional supplementation. Specific Aims: Demonstrate the important role β-hydroxy β-methyl butyrate (HMB) supplementation with or without high protein nutrition supplement in patients undergoing major surgeries and their outcomes. Develop the current ERAS protocol used in Community Regional Medical Center by determining the best oral nutrition supplement prior to surgery Emphasize the importance of using oral nutrition supplements before major surgeries to decrease the patient's recovery after surgeries.

Official Title
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Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes

Conditions
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Major Abdominal/GI Surgery

Intervention / Treatment
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* Dietary Supplement: HMB
* Dietary Supplement: Protein and HMB
* Dietary Supplement: ERAS


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Dr. Amir Fathi as attending surgeon Adult patients (age >18) undergoing major abdominal and GI surgeries Patients at risk for malnutrition based on the ASPEN and The Academy malnutrition criteria Exclusion Criteria: Pediatric patients Patients undergoing chemotherapy or radiation Patients with known allergies to products (Ensure Enlive, HMB) Patients that are unable to comply with all requirements Vegan patients Pregnant patients Prisoners

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: HMB only<br>Taking HMB supplements three times a day | Dietary Supplement: HMB<br>* Patients in the first group (HMB only) will take 3 capsules of HMB by VitaMonk™ (1000mg/capsule) daily (morning, noon, and night) for 5 days prior to surgery.<br>|
| Experimental: Protein and HMB<br>Drinking Ensure Enlive shakes | Dietary Supplement: Protein and HMB<br>* Patients in the second group (HMB + protein) will drink 2- 8oz bottles of Ensure Enlive daily (morning and night) for 5 days prior to surgery. Each bottle contains 1500mg of HMB and 20 g of protein.<br>|
| Experimental: Current ERAS (High Protein)<br>Drinking Ensure surgery shakes + Ensure pre-surgery | Dietary Supplement: ERAS<br>* Patients in the third group (High protein) will drink 2- 8oz bottles of Ensure surgery daily (morning and night) for 5 days prior to surgery. Each bottle contains 18g of protein. and a clear 50g Pre-surgery drink on the day of surgery<br>* Other names: Protein;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Patient length of hospital stay | Length of hospital stay (LOS) will be measured for all participating patients. Average LOS in the intervention group will be compared with the average LOS in the control group. | day seven and day thirty after surgery | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change in transcriptional key proteins expression level | Western blot analysis of muscle obtained at biopsy from patients | one year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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MUST: Malnutrition Universal Screening Tool, MST: Malnutrition Screening Tool, SGA: Subjective Global Assessment, REE: Resting Energy Expenditure, IC: Indirect calorimetry, HMB: β-hydroxy β-methylbutyrate, MNA: Mini Nutrition Assessment, GMS: Graz Malnutrition Screening