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

Primary Purpose

Colon Cancer

Status

Completed

Phase

Not Applicable

Locations

Canada

Study Type

Interventional

Intervention

Oral Nutrition with dextrose and pressurized whey protein

Peripheral Parenteral Nutrition

About this trial

This is an interventional supportive care trial for Colon Cancer focused on measuring Bowel resection

Eligibility Criteria

18 Years - 85 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

Oral Nutrition

Peripheral Parenteral Nutrition

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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.

Full Information

NCT ID

NCT01222208

First Posted

October 14, 2010

Last Updated

February 3, 2012

Sponsor

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

Collaborators

Montreal General Hospital, McGill University

1. Study Identification

Unique Protocol Identification Number

NCT01222208

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

February 2012

Overall Recruitment Status

Completed

Study Start Date

March 2011 (undefined)

Primary Completion Date

November 2011 (Actual)

Study Completion Date

November 2011 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

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

Collaborators

Montreal General Hospital, McGill University

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Colon Cancer

Keywords

Bowel resection

7. Study Design

Primary Purpose

Supportive Care

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Oral Nutrition

Arm Type

Active Comparator

Arm Description

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

Arm Title

Peripheral Parenteral Nutrition

Arm Type

Placebo Comparator

Arm Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Oral Nutrition with dextrose and pressurized whey protein

Intervention Description

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.

Intervention Type

Dietary Supplement

Intervention Name(s)

Peripheral Parenteral Nutrition

Intervention Description

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 Outcome Measure Information:

Title

Whole body protein balance

Description

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

Time Frame

1 year

Secondary Outcome Measure Information:

Title

Synthesis rates of hepatic secretory proteins

Description

Time Frame

1 year

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

85 Years

Accepts Healthy Volunteers

Eligibility Criteria

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Franco Carli, M.D.

Organizational Affiliation

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

Official's Role

Principal Investigator

Facility Information:

Facility Name

Montreal General Hospital

City

Montreal

State/Province

Quebec

ZIP/Postal Code

H3G 1A4

Country

Canada

12. IPD Sharing Statement

Citations:

PubMed Identifier

19092350

Citation

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.

Results Reference

result

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

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