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

This study has been completed.
Sponsor:
Information provided by:
Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier:
NCT01354249
First received: May 10, 2011
Last updated: May 13, 2011
Last verified: May 2011
History of Changes
  Purpose

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 Intervention
Acute Phase Response
Insulin Resistance
 Dietary Supplement: whey protein plus carbohydrate drink

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, 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.

Resource links provided by NLM:

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

Further study details as provided by Federal University of Mato Grosso do Sul:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation ] [ Designated as safety issue: No ]
    Insulin resistance will be assessed by Homa-IR


Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]
    Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein
Enrollment: 20
Study Start Date: July 2010
Study Completion Date: October 2010
Primary Completion Date: October 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility
Ages Eligible for Study:   18 Years to 65 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: 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

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

No publications provided by Federal University of Mato Grosso do Sul

Additional 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
Study First Received: May 10, 2011
Last Updated: May 13, 2011
Health Authority: Brazil: Ethics Committee

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

Additional relevant MeSH terms:
Acute-Phase Reaction
Insulin Resistance
Glucose Metabolism Disorders
Hyperinsulinism
 Inflammation
Metabolic Diseases
Pathologic Processes

ClinicalTrials.gov processed this record on March 03, 2015