Skip to main content
OpenTrials
Completed

NCT Number: NCT01354249

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.

Completed

Looking for future studies?

Notify Me

Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hospital Julio Muller

Cuiabá, Mato Grosso, 78000-000, Brazil

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

whey protein plus carbohydrate drink

Dietary Supplement

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 names: Resource® Breeze - Nestlé, São Paulo, Brasil

Primary outcomes

  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 outcomes

  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

Sponsors and collaborators

Lead sponsor

Federal University of Mato Grosso

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2010
Study completion
2010
First posted
May 16, 2011
Registry last updated
May 16, 2011

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.