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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

May 10, 2011
May 13, 2011
July 2010
October 2010   (final data collection date for primary outcome measure)
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
Same as current
Complete list of historical versions of study NCT01354249 on ClinicalTrials.gov Archive Site
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
Same as current
Not Provided
Not Provided
 
Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance
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.

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

Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Factorial Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
  • Acute Phase Response
  • Insulin Resistance
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
  • Placebo Comparator: water
    Patients will receive water 3h before operation in the same volume of the study group
    Intervention: Dietary Supplement: whey protein plus carbohydrate drink
  • 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)
    Intervention: Dietary Supplement: whey protein plus carbohydrate drink
Perrone F, da-Silva-Filho AC, Adôrno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damião A, de Aguilar-Nascimento JE. Effects of preoperative feeding with a whey protein plus carbohydrate drink on the acute phase response and insulin resistance. A randomized trial. Nutr J. 2011 Jun 13;10:66. doi: 10.1186/1475-2891-10-66.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
20
October 2010
October 2010   (final data collection date for primary outcome measure)

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.
Both
18 Years to 65 Years
No
Contact information is only displayed when the study is recruiting subjects
Brazil
 
NCT01354249
fperrone
Yes
Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso
Federal University of Mato Grosso do Sul
Not Provided
Principal Investigator: Jose Aguilar-Nascimento, D, PhD Federal University of Mato Grosso do Sul
Federal University of Mato Grosso do Sul
May 2011

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP