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| Name | Class |
|---|---|
| California State university, Fresno, Department of Food Science and Nutrition | OTHER |
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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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| HMB only | Experimental | Taking HMB supplements three times a day |
|
| Protein and HMB | Experimental | Drinking Ensure Enlive shakes |
|
| Current ERAS (High Protein) | Experimental | Drinking Ensure surgery shakes + Ensure pre-surgery |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in transcriptional key proteins expression level | Western blot analysis of muscle obtained at biopsy from patients | one year |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Amir H Fathi, MD | Contact | (559) 256-5140 | AFathi@fresno.ucsf.edu | |
| Shabnam Pooya, PhD | Contact | 9099915887 | shabnampooya@csufresno.edu |
| Name | Affiliation | Role |
|---|---|---|
| Amir h Fathi, MD | University of California, San Francisco | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Community Regional Medical Center | Recruiting | Fresno | California | 93721 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 11680474 | Background | Studley HO. Percentage of weight loss: a basic indicator of surgical risk in patients with chronic peptic ulcer. 1936. Nutr Hosp. 2001 Jul-Aug;16(4):141-3; discussion 140-1. No abstract available. | |
| Background | Fairfield KM, Askari R, Lipman TO, Sanfey H, Collins KA. Overview of perioperative nutritional support. UpToDate. Last full review/revision: September. 2014 | ||
| 21224430 |
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| ID | Term |
|---|---|
| D011506 | Proteins |
| ID | Term |
|---|---|
| D000602 | Amino Acids, Peptides, and Proteins |
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| 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. |
|
| 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 |
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