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Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients


N/A
18 Years
90 Years
Not Enrolling
Both
Protein Metabolism, Colorectal Neoplasms

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Trial Information

Whey Protein-based Enteral Nutrition Support to Improve Protein Economy in Surgical Patients


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.

Type of Study:

Interventional

Study Design:

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

Outcome Measure:

Protein balance

Outcome Description:

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.

Outcome Time Frame:

Assessed for 6 hours one time before surgery and once again on the second post-op day

Safety Issue:

No

Principal Investigator

Franco Carli, MD PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

McGill University

Authority:

Canada: Ethics Review Committee

Study ID:

09-053-SDR

NCT ID:

NCT01276795

Start Date:

January 2010

Completion Date:

August 2010

Related Keywords:

  • Protein Metabolism
  • Colorectal Neoplasms
  • Neoplasms
  • Colorectal Neoplasms

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