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

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.

Conditions

• Major Abdominal/GI Surgery

Interventions

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.

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.

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

Sponsors & Collaborators

• California State university, Fresno, Department of Food Science and Nutrition

  collaborator OTHER

• University of California, San Francisco

  lead OTHER

Principal Investigators

• Amir h Fathi, MD · University of California, San Francisco

Study Design

Allocation

RANDOMIZED

Purpose

PREVENTION

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

Yes

Timeline & Regulatory

Start

2021-07-30

Primary Completion

2021-12-01

Completion

2022-12-30

Countries

• United States

Study Locations