Clinical trial NCT03692507: Effects of Nutritional Preconditioning on the Patient's Outcomes After Surgery
Official title: Effects of Nutritional Preconditioning on the Nutritional Status of Patients Undergoing Major General Surgeries and Subsequent Operative Outcomes
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Major Abdominal/GI Surgery
Keywords: HMB: β-hydroxy β-methylbutyrate
MNA: Mini Nutrition Assessment
GMS: Graz Malnutrition Screening
MUST: Malnutrition Universal Screening Tool
MST: Malnutrition Screening Tool
SGA: Subjective Global Assessment
REE: Resting Energy Expenditure
IC: Indirect calorimetry
Lead sponsor: University of California, San Francisco
Sponsor class: OTHER
Collaborators: name: California State university, Fresno, Department of Food Science and Nutrition
First posted: 2018-10-02
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

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.

Eligibility criteria: 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

Primary outcomes:
measure: Patient length of hospital stay
timeFrame: day seven and day thirty after surgery
Secondary outcomes:
measure: Change in transcriptional key proteins expression level
timeFrame: one year
Other outcomes:
Locations:
city: Fresno
country: United States
facility: Community Regional Medical Center
state: California
Study officials:
affiliation: University of California, San Francisco
name: Amir h Fathi, MD
role: PRINCIPAL_INVESTIGATOR
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