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

Sponsor

University of California, San Francisco (Other)

Overall Status

Recruiting

CT.gov ID

NCT03692507

Collaborator

California State university, Fresno, Department of Food Science and Nutrition (Other)

Enrollment

Location

Arms

Anticipated Duration (Months)

1.2

Patients Per Site Per Month

Study Details

Study Description

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:

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.

Condition or Disease	Intervention/Treatment	Phase
Major Abdominal/GI Surgery	Dietary Supplement: HMB Dietary Supplement: Protein and HMB Dietary Supplement: ERAS	N/A

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 Design

Study Type:

Interventional

Anticipated Enrollment :

20 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Prevention

Official Title:

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

Anticipated Study Start Date :

Jul 30, 2021

Anticipated Primary Completion Date :

Dec 1, 2021

Anticipated Study Completion Date :

Dec 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: HMB only Taking HMB supplements three times a day	Dietary Supplement: HMB 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.
Experimental: Protein and HMB Drinking Ensure Enlive shakes	Dietary Supplement: Protein and HMB 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.
Experimental: Current ERAS (High Protein) Drinking Ensure surgery shakes + Ensure pre-surgery	Dietary Supplement: ERAS 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 Other Names: Protein

Arm

Intervention/Treatment

Experimental: HMB only

Taking HMB supplements three times a day

Dietary Supplement: HMB

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.

Experimental: Protein and HMB

Drinking Ensure Enlive shakes

Dietary Supplement: Protein and HMB

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.

Experimental: Current ERAS (High Protein)

Drinking Ensure surgery shakes + Ensure pre-surgery

Dietary Supplement: ERAS

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

Other Names:

Protein

Outcome Measures

Primary Outcome Measures

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

Change in transcriptional key proteins expression level [one year]
Western blot analysis of muscle obtained at biopsy from patients

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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