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

Not Applicable

Completed

• Conditions: Acute Phase Response; Insulin Resistance
• Interventions: Dietary Supplement: whey protein plus carbohydrate drink

• Registration Number: NCT01354249
• Lead Sponsor: Federal University of Mato Grosso

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.

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 Timeline

• Study Start: 2010-07
• Primary Completion: 2010-10
• Study Completion: 2010-10
• Status Verified: 2011-05
• Study First Submitted: 2011-05-10
• Study First Submitted QC: 2011-05-13
• Last Update Submitted: 2011-05-13
• Study First Posted: 2011-05-16
• Last Update Posted: 2011-05-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: FACTORIAL

Arm && Interventions

Group	Intervention	Description
water	whey protein plus carbohydrate drink	Patients will receive water 3h before operation in the same volume of the study group
whey protein plus carbohydrate	whey protein plus carbohydrate drink	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)

Primary Outcome Measures

Name	Time	Method
insulin resistance	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

Name	Time	Method
acute-phase response	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

Trial Locations

Locations (1)

Hospital Julio Muller; 🇧🇷 Cuiaba, Mato Grosso, Brazil