Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance

May 13, 2011 updated by: Federal University of Mato Grosso

Effects of Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance.

Prolonged fasting may increase the organic response to trauma. Carbohydrate-based drinks have been tested and they may reduce insulin resistance. No study so far has aimed to examine the possible benefits of whey protein drink in the composition of preoperative drinks.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The patients will be randomized into two groups: the carbohydrate-protein group (CHO-P) and the control group (CO). The patients will reeive a specific drink to their group on the evening prior to surgery and three hours before the operation. The CHO-P group will receive 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil) and the CO group will receive the same volume of water.

Outcome measures On the day of the surgery and on the first postoperative day blood samples will be collected for glucose, insulin, triglycerides, albumin, pre-albumin, CRP, and α-1-acid glycoprotein (α-1-GA) assays. HOMA-IR will be calculated

Study Type

Interventional

Enrollment (Actual)

20

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Mato Grosso
      • Cuiaba, Mato Grosso, Brazil, 78000-000
        • Hospital Julio Muller

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Adults (18-65 years-old)
  • Both sexes
  • Candidates to elective moderate operations such as open cholecystectomy, laparoscopic cholecystectomy and unilateral repair of inguinal hernia).

Exclusion Criteria:

  • Acute cholecystitis
  • Diabetes mellitus
  • Chronic kidney failure
  • Chronic liver disease ot serum bilirubin greater than 2 mg/dL, body mass index (BMI) above 35Kg/m2
  • American Anesthesiologists Association (ASA) score above 2
  • Gastro-esophageal reflux
  • Gastroparesis or intestinal obstruction
  • Patients with any non-compliance with the study protocol, or who had associated operations, or presented significant intraoperative occurrences, or experienced prolonged operations (lasting more than 3 hours) were also excluded.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: water
Patients will receive water 3h before operation in the same volume of the study group
Dietary supplement: whey protein plus carbohydrate drink
The CHO-P group received 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
Other Names:
  • Resource® Breeze - Nestlé, São Paulo, Brasil
Experimental: whey protein plus carbohydrate
The CHO-P group will receive 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
Dietary supplement: whey protein plus carbohydrate drink
The CHO-P group received 474 ml (evening drink) or 237 ml (3h prior to operation drink) of a solution containing 14% whey protein (100% lactoalbumin), 86% carbohydrates (45% hydrolyzed corn starch and 55% sucrose) and 0% lipids (Resource® Breeze - Nestlé, São Paulo, Brasil)
Other Names:
  • Resource® Breeze - Nestlé, São Paulo, Brasil

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
insulin resistance
Time Frame: Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation
Insulin resistance will be assessed by Homa-IR
Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
acute-phase response
Time Frame: Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation
Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein
Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Federal University of Mato Grosso

Investigators

  • Principal Investigator: Jose Aguilar-Nascimento, D, PhD, Federal University of Mato Grosso

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2010

Primary Completion (Actual)

October 1, 2010

Study Completion (Actual)

October 1, 2010

Study Registration Dates

First Submitted

May 10, 2011

First Submitted That Met QC Criteria

May 13, 2011

First Posted (Estimate)

May 16, 2011

Study Record Updates

Last Update Posted (Estimate)

May 16, 2011

Last Update Submitted That Met QC Criteria

May 13, 2011

Last Verified

May 1, 2011

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • fperrone

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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