NCT01276795

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
13

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2010

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2010

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

January 12, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 13, 2011

Completed
Last Updated

January 13, 2011

Status Verified

July 1, 2010

Enrollment Period

7 months

First QC Date

January 12, 2011

Last Update Submit

January 12, 2011

Conditions

Protein MetabolismColorectal Neoplasms

Outcome Measures

Primary Outcomes (1)

  • 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

Study Arms (2)

Glucose and whey protein

EXPERIMENTAL

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.

Dietary Supplement: Oral Nutrition Support

Glucose only

ACTIVE COMPARATOR

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.

Dietary Supplement: Oral Nutrition Support

Interventions

Oral Nutrition SupportDIETARY_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 and whey proteinGlucose only

Eligibility Criteria

Age18 Years - 90 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Colorectal Neoplasms

Interventions

Nutrition Therapy

Condition Hierarchy (Ancestors)

Intestinal NeoplasmsGastrointestinal NeoplasmsDigestive System NeoplasmsNeoplasms by SiteNeoplasmsDigestive System DiseasesGastrointestinal DiseasesColonic DiseasesIntestinal DiseasesRectal Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Study Officials

  • Franco Carli, MD PhD

    McGill University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

January 12, 2011

First Posted

January 13, 2011

Study Start

January 1, 2010

Primary Completion

August 1, 2010

Study Completion

August 1, 2010

Last Updated

January 13, 2011

Record last verified: 2010-07

Locations

CA(1)