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

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT01276795
Enrollment
13
Registered
2011-01-13
Start date
2010-01-31
Completion date
2010-08-31
Last updated
2011-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Colorectal Neoplasms, Protein Metabolism

Brief 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.

Interventions

DIETARY_SUPPLEMENTOral 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.

Sponsors

McGill University
CollaboratorOTHER
McGill University Health Centre/Research Institute of the McGill University Health Centre
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 90 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Protein balanceAssessed for 6 hours one time before surgery and once again on the second post-op dayProtein 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.

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026