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Completed

NCT Number: NCT01222208

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

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.

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Key information

Conditions

Colon Cancer Colonic Diseases Colonic Neoplasms Colorectal Neoplasms Digestive System Diseases Digestive System Neoplasms Gastrointestinal Diseases Gastrointestinal Neoplasms Intestinal Diseases Intestinal Neoplasms Neoplasms Neoplasms by Site

Age range

18 year–85 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • The American Society of Anesthesiologists' (ASA) class 1 to 3
  • Colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total, and hemicolectomy)
  • 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

  • History of hepatic failure (Child-Pugh score A-C and transaminases outside the normal range)
  • Renal impairment (Serum Creatinine outside normal range)
  • Cardiac failure (New York Heart Association (NYHA) classes I-IV)
  • Hepatic, Renal, Cardiac transplant
  • Endocrine disorders: diabetes type I & II, hyper and hypothyroidism
  • Active inflammatory bowel or diverticular disease (Crohn's Disease, Ulcerative Colitis)
  • Musculoskeletal or neuromuscular disease
  • Anemia defined as hematocrit < 30, hemoglobin < 10 g/dl, albumin < 25 mg/dl
  • Previous spine surgery or scoliosis limiting use of epidural
  • Pregnancy
  • Use of Steroids
  • Milk protein allergy or intolerance

Treatment and study plan

Oral Nutrition with dextrose and pressurized whey protein

Dietary Supplement

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 Nutrition

Dietary 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.

Primary outcomes

  1. Whole body protein balance

    Time frame: 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 outcomes

  1. Synthesis rates of hepatic secretory proteins

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

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

Other

Collaborators

  • McGill University
  • Montreal General Hospital

Registry information

Official study title

Oral Versus Parenteral Perioperative Nutrition Support to Improve Protein Balance: Stable Isotope Study in Colorectal Surgical Patients

Important dates

Study start
2011
Primary completion
2011
Study completion
2011
First posted
Oct 18, 2010
Registry last updated
Feb 7, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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