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

NCT03692507 | Unknown

• 1 other identifier: 2018006
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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. 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. 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

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

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Change in transcriptional key proteins expression level

  one year

Study Arms (3)

HMB only

EXPERIMENTAL

Taking HMB supplements three times a day

Dietary Supplement: HMB

Protein and HMB

EXPERIMENTAL

Drinking Ensure Enlive shakes

Dietary Supplement: Protein and HMB

Current ERAS (High Protein)

EXPERIMENTAL

Drinking Ensure surgery shakes + Ensure pre-surgery

Dietary Supplement: ERAS

Interventions

HMB DIETARY_SUPPLEMENT

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.

HMB only

Protein and HMB DIETARY_SUPPLEMENT

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.

Protein and HMB

ERAS DIETARY_SUPPLEMENT

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

Also known as: Protein

Current ERAS (High Protein)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of California, San Francisco: lead
• California State university, Fresno, Department of Food Science and Nutrition: collaborator

Study Sites (1)

Community Regional Medical Center

Fresno, California, 93721, United States

RECRUITING

Related Publications (34)

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  BACKGROUND

MeSH Terms

Interventions

Proteins

Intervention Hierarchy (Ancestors)

Amino Acids, Peptides, and Proteins

Study Officials

• Amir h Fathi, MD

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Amir H Fathi, MD

CONTACT

(559) 256-5140; AFathi@fresno.ucsf.edu

Shabnam Pooya, PhD

CONTACT

9099915887; shabnampooya@csufresno.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 5, 2018
• First Posted: October 2, 2018
• Study Start: July 30, 2021
• Primary Completion: December 1, 2021
• Study Completion: December 30, 2022
• Last Updated: July 2, 2021

Record last verified: 2021-06

Locations

US (1)