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

Colon Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01222208
• Other study ID #: 10-106-GEN
• Status: Completed
• Phase: N/A
• First received: October 14, 2010
• Last updated: February 3, 2012
• Start date: March 2011
• Est. completion date: November 2011

Study information

• Verified date: February 2012
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Health authority: Canada: Ethics Review Committee
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 20
• Est. completion date: November 2011
• Est. primary completion date: November 2011
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 85 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Supportive Care

Related Conditions & MeSH terms

• Colon Cancer

Intervention

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.
• 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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (3)

Lead Sponsor	Collaborator
McGill University Health Center	McGill University, Montreal General Hospital

Country where clinical trial is conducted

Canada, 

References & 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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	No
Secondary	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.	1 year	No