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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT01276795
Other study ID # 09-053-SDR
Secondary ID
Status Completed
Phase N/A
First received January 12, 2011
Last updated January 12, 2011
Start date January 2010
Est. completion date August 2010

Study information

Verified date July 2010
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 and controlled study is proposed to establish whether an enteral nutrition support regimen based on pressurized whey protein and glucose improves the postoperative utilization of amino acid substrates compared to a drink based on glucose alone. The kinetics of protein metabolism (protein breakdown, protein synthesis and amino acid oxidation) will be investigated using stable isotope methodology before and after surgery in patients undergoing colon resection. Stable isotope infusions will be conducted one week before surgery and on the second postoperative day for two hours in the fasted state and for four hours while sipping the enteral nutrition support regimen. Patients will consume one of two enteral nutrition support regimens consisting of a drink containing either pressurized whey protein and glucose or glucose alone. It is hypothesized that an enteral nutrition support regimen based on pressurized whey protein and glucose promotes positive protein balance through increased protein synthesis or reduced protein breakdown compared to glucose alone.


Recruitment information / eligibility

Status Completed
Enrollment 13
Est. completion date August 2010
Est. primary completion date August 2010
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 90 Years
Eligibility Inclusion Criteria:

- age older than 18 years

- ASA class I to III

- colorectal surgery for non-metastatic disease (including right, transverse, left, sigmoid, subtotal, total and hemicolectomy and low anterior resection)

- body mass index >17 and <30 kg.m-2

- stable weight over the preceding three months (<10 % body weight loss)

- serum albumin >35 g/L

Exclusion Criteria:

- severe cardiac, renal or hepatic failure

- diabetes

- hyper and hypothyroidism

- active inflammatory bowel or diverticular disease

- musculoskeletal or neuromuscular disease

- anemia (hematocrit <30)

- albumin < 25 g/l

- pregnancy

- use of steroids.

Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Supportive Care


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Oral Nutrition Support
The patients will sip the oral nutrition support (in the form of a drink) over the course of 4 hours within each 6 hour study. Each patient will be studied once before surgery and once after surgery.

Locations

Country Name City State
Canada Montreal General Hospital Montreal Quebec

Sponsors (2)

Lead Sponsor Collaborator
McGill University Health Center McGill University

Country where clinical trial is conducted

Canada, 

Outcome

Type Measure Description Time frame Safety issue
Primary Protein balance Protein balance is assessed using the stable isotope tracer C-13 leucine. Protein breakdown, protein synthesis and amino acid oxidation are measured through blood and expired air samples. Assessed for 6 hours one time before surgery and once again on the second post-op day No
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