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

NCT ID: NCT01276795

Last Updated: 2011-01-13

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 13 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2010-01-31
• Study Completion Date: 2010-08-31

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.

Conditions

Protein Metabolism; Colorectal Neoplasms

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: SUPPORTIVE_CARE
• Blinding Strategy: SINGLE

Study Groups

Glucose and whey protein

Patients who are randomly allocated to this group will receive a drink made of anhydrous beet dextrose and pressurized whey protein in water (200 g/L + 100g/L). Patients will sip the drink for 4 hours of the 6 hour study.

Group Type: EXPERIMENTAL

Oral Nutrition Support

Intervention Type: DIETARY_SUPPLEMENT

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.

Glucose only

The patients who are randomly allocated to this arm will receive a drink composed of anhydrous beet dextrose in water (200g/L). They will sip the drink for 4 hours of the 6 hour study.

Group Type: ACTIVE_COMPARATOR

Oral Nutrition Support

Intervention Type: DIETARY_SUPPLEMENT

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.

Interventions

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.

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 90 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

McGill University

OTHER

Sponsor Role: collaborator

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

OTHER

Sponsor Role: lead

Responsible Party

McGill University

Principal Investigators

Franco Carli, MD PhD

Role: PRINCIPAL_INVESTIGATOR

McGill University

Locations

Montreal General Hospital

Montreal, Quebec, Canada

Countries

Canada

Other Identifiers

09-053-SDR

Identifier Type: -

Identifier Source: org_study_id