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

NCT01222208 | Completed

• 1 other identifier: 10-106-GEN
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

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.

Conditions

Colon Cancer

Keywords

Bowel resection

Outcome Measures

Primary Outcomes (1)

• 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

  1 year

Secondary Outcomes (1)

• Synthesis rates of hepatic secretory proteins

  1 year

Study Arms (2)

Oral Nutrition

ACTIVE COMPARATOR

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

Dietary Supplement: Oral Nutrition with dextrose and pressurized whey protein

Peripheral Parenteral Nutrition

PLACEBO COMPARATOR

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.

Dietary Supplement: Peripheral Parenteral Nutrition

Interventions

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.

Oral Nutrition

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.

Peripheral Parenteral Nutrition

Eligibility Criteria

• Age: 18 Years - 85 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• McGill University Health Centre/Research Institute of the McGill University Health Centre: lead
• Montreal General Hospital: collaborator
• McGill University: collaborator

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

Related Publications (1)

• Schricker T, Meterissian S, Lattermann R, Adegoke OA, Marliss EB, Mazza L, Eberhart L, Carli F, Nitschman E, Wykes L. Anticatabolic effects of avoiding preoperative fasting by intravenous hypocaloric nutrition: a randomized clinical trial. Ann Surg. 2008 Dec;248(6):1051-9. doi: 10.1097/SLA.0b013e31818842d8.

  PMID: 19092350 RESULT

MeSH Terms

Conditions

Colonic Neoplasms

Interventions

Nutritional Status; Glucose

Condition Hierarchy (Ancestors)

Colorectal Neoplasms; Intestinal Neoplasms; Gastrointestinal Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Neoplasms; Digestive System Diseases; Gastrointestinal Diseases; Colonic Diseases; Intestinal Diseases

Intervention Hierarchy (Ancestors)

Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena; Health Status; Demography; Population Characteristics; Hexoses; Monosaccharides; Sugars; Carbohydrates

Study Officials

• Franco Carli, M.D.

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Dr. Franco Carli

Study Record Dates

• First Submitted: October 14, 2010
• First Posted: October 18, 2010
• Study Start: March 1, 2011
• Primary Completion: November 1, 2011
• Study Completion: November 1, 2011
• Last Updated: February 7, 2012

Record last verified: 2012-02

Locations

CA (1)