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

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ClinicalTrials.gov Identifier: NCT01354249
Recruitment Status : Completed
First Posted : May 16, 2011
Last Update Posted : May 16, 2011
Sponsor:
Information provided by:
Federal University of Mato Grosso do Sul

Study Description
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Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Acute Phase Response Insulin Resistance Dietary Supplement: whey protein plus carbohydrate drink Not Applicable

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 20 participants
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effects of Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance.
Study Start Date : July 2010
Actual Primary Completion Date : October 2010
Actual Study Completion Date : October 2010

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Arms and Interventions
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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 Name: 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 Name: Resource® Breeze - Nestlé, São Paulo, Brasil


Outcome Measures
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Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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


Eligibility Criteria
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Ages Eligible for Study:   18 Years to 65 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354249


Locations
Brazil
Hospital Julio Muller
Cuiaba, Mato Grosso, Brazil, 78000-000
Sponsors and Collaborators
Federal University of Mato Grosso do Sul
Investigators
Principal Investigator: Jose Aguilar-Nascimento, D, PhD Federal University of Mato Grosso do Sul
More Information
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Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Additional Information:
Projeto Acerto  This link exits the ClinicalTrials.gov site

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
ClinicalTrials.gov Identifier: NCT01354249     History of Changes
Other Study ID Numbers: fperrone
First Posted: May 16, 2011    Key Record Dates
Last Update Posted: May 16, 2011
Last Verified: May 2011

Keywords provided by Federal University of Mato Grosso do Sul:
preoperative fasting
insulin resistance
carbohydrates
whey protein
inflammatory response

Additional relevant MeSH terms:
Insulin Resistance
Acute-Phase Reaction
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
 Inflammation
Pathologic Processes
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs