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

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.

Conditions

• Colon Cancer

Interventions

DIETARY_SUPPLEMENT

Oral Nutrition with dextrose and pressurized whey protein

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.

DIETARY_SUPPLEMENT

Peripheral Parenteral Nutrition

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.

Sponsors & Collaborators

• Montreal General Hospital

  collaborator OTHER

• McGill University

  collaborator OTHER

• McGill University Health Centre/Research Institute of the McGill University Health Centre

  lead OTHER

Principal Investigators

• Franco Carli, M.D. · McGill University Health Centre/Research Institute of the McGill University Health Centre

Study Design

Allocation

RANDOMIZED

Purpose

SUPPORTIVE_CARE

Masking

NONE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

85 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2011-03-31

Primary Completion

2011-11-30

Completion

2011-11-30

Countries

• Canada

Study Locations