Clinical trial NCT01354249: Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance
Official title: Effects of Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance.
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Acute Phase Response
Insulin Resistance
Keywords: preoperative fasting
insulin resistance
carbohydrates
whey protein
inflammatory response
Lead sponsor: Federal University of Mato Grosso
Sponsor class: OTHER
First posted: 2011-05-16
Enrollment: 20
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: FACTORIAL
Primary purpose: TREATMENT

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

Eligibility 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.

Primary outcomes:
measure: insulin resistance
timeFrame: Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation
Secondary outcomes:
measure: acute-phase response
timeFrame: Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation
Other outcomes:
Locations:
city: Cuiaba
country: Brazil
facility: Hospital Julio Muller
state: Mato Grosso
Study officials:
affiliation: Federal University of Mato Grosso
name: Jose Aguilar-Nascimento, D, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Perrone F, da-Silva-Filho AC, Adorno IF, Anabuki NT, Leal FS, Colombo T, da Silva BD, Dock-Nascimento DB, Damiao 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.