Oral Versus Parenteral Nutrition Support to Improve Protein Balance in Colorectal Surgical Patients

McGill University Health Centre/Research Institute of the McGill University Health Centre20 enrolled

Overview

A prospective, randomized controlled study, using stable isotope methodology, is proposed to determine whether an oral nutrition support regimen, containing pressurized whey protein and glucose, is more effective at normalizing the metabolic response to surgery than a standard peripheral parenteral nutrition (PPN) support regimen, containing amino acids and glucose, in colorectal surgical patients studied before and after surgery. The effectiveness of the nutrition support regimens will be determined by: whole body protein balance, synthesis rates of hepatic secretory proteins, resting energy expenditure and substrate utilization, as well as circulating metabolites concentrations.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Enrollment

Conditions

Colon Cancer

Interventions

Ten (10) subjects will be randomly assigned to receive an oral nutrition regimen comprised of 50% of their REE as dextrose and 20% of their REE as pressurized whey protein. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned oral nutrition regimen. To minimize fasting during the perioperative period all subjects will receive peripheral parenteral nutrition (PPN) at the time of surgical incision until the first postoperative day.

Peripheral Parenteral NutritionDIETARY_SUPPLEMENT

Ten (10) subjects will be randomly assigned to receive peripheral parenteral nutrition (PPN) regimen comprised of 50% of their REE as dextrose and 20% of their REE as amino acids. Subjects will undergo a six-hour stable isotope infusion protocol one day before surgery (to obtain baseline data) and on the first post-operative day. During both infusion protocols, subjects will be asked to carry out their assigned PPN regimen. To minimize fasting during the perioperative period all subjects will receive PPN at the time of surgical incision until the first postoperative day.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 85 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. The American Society of Anesthesiologists' (ASA) class 1 to 3 2. Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy) 3. Nutrition status: 18.5 \< body mass index \< 30 kg/m2, stable weight over the preceding three months (\< 10% body weight loss), serum albumin \> 35g/l Exclusion Criteria: 1. History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range) 2. Renal impairment (Serum Creatinine outside normal range) 3. Cardiac failure (New York Heart Association (NYHA) classes I-IV) 4. Hepatic, Renal, Cardiac transplant 5. Endocrine disorders: diabetes type I \& II, hyper and hypothyroidism 6. Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis) 7. Musculoskeletal or neuromuscular disease 8. Anemia defined as hematocrit \< 30, hemoglobin \< 10 g/dl, albumin \< 25 mg/dl 9. Previous spine surgery or scoliosis limiting use of epidural 10. Pregnancy 11. Use of Steroids 12. Milk protein allergy or intolerance

Outcomes

Primary Outcomes

Whole body protein balance

Whole body protein balance (the difference between protein synthesis and protein breakdown) as assessed by the kinetics of a stable, non-radioactive, isotope tracer infusion of L-\[1-13C\] leucine

Time frame: 1 year

Secondary Outcomes

Synthesis rates of hepatic secretory proteins

Synthesis rates of hepatic secretory proteins, including the classically positive acute phase reactant fibrinogen and the classically negative acute phase reactant albumin, as assessed by incorporation of the stable, non-radioactive, isotope tracer L-\[2H5\] phenylalanine into plasma Very Low Density Lipoprotein ApolipoproteinB100.