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

Not Applicable

Completed

• Conditions: Colon Cancer
• Interventions: Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein; Dietary Supplement: Peripheral Parenteral Nutrition

• Registration Number: NCT01222208
• Lead Sponsor: McGill University Health Centre/Research Institute of the McGill University Health Centre

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2010-10-14
• Study First Submitted QC: 2010-10-15
• Study First Posted: 2010-10-18
• Study Start: 2011-03
• Primary Completion: 2011-11
• Study Completion: 2011-11
• Status Verified: 2012-02
• Last Update Submitted: 2012-02-03
• Last Update Posted: 2012-02-07

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Oral Nutrition	Oral Nutrition with dextrose and pressurized whey protein	Subjects will receive an oral nutrition regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as pressurized whey protein
Peripheral Parenteral Nutrition	Peripheral Parenteral Nutrition	Subjects will receive a peripheral parenteral nutrition (PPN) regimen comprised of 50% of their Resting Energy Expenditure (REE) as dextrose and 20% of their REE as amino acids.

Primary Outcome Measures

Name	Time	Method
Whole body protein balance	1 year	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

Secondary Outcome Measures

Name	Time	Method
Synthesis rates of hepatic secretory proteins	1 year	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.

Trial Locations

Locations (1)

Montreal General Hospital; 🇨🇦 Montreal, Quebec, Canada