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

Not Applicable

• Conditions: Major Abdominal/GI Surgery
• Interventions: Dietary Supplement: Protein and HMB; Dietary Supplement: ERAS; Dietary Supplement: HMB

• Registration Number: NCT03692507
• Lead Sponsor: University of California, San Francisco

Brief Summary

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:

1. 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.

2. 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

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.

Study Timeline

• Study First Submitted: 2018-06-05
• Study First Submitted QC: 2018-09-29
• Study First Posted: 2018-10-02
• Status Verified: 2021-06
• Last Update Submitted: 2021-06-29
• Last Update Posted: 2021-07-02
• Study Start: 2021-07-30
• Primary Completion: 2021-12-01
• Study Completion: 2022-12-30

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

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

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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

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Protein and HMB	Protein and HMB	Drinking Ensure Enlive shakes
Current ERAS (High Protein)	ERAS	Drinking Ensure surgery shakes + Ensure pre-surgery
HMB only	HMB	Taking HMB supplements three times a day

Primary Outcome Measures

Name	Time	Method
Patient length of hospital stay	day seven and day thirty after surgery	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.

Secondary Outcome Measures

Name	Time	Method
Change in transcriptional key proteins expression level	one year	Western blot analysis of muscle obtained at biopsy from patients

Trial Locations

Locations (1)

Community Regional Medical Center; 🇺🇸 Fresno, California, United States