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

Study Overview
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Brief Summary
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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
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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

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

Conditions
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Acute Phase Response, Insulin Resistance

Intervention / Treatment
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* Dietary Supplement: whey protein plus carbohydrate drink


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 65 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Factorial Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: water<br>Patients will receive water 3h before operation in the same volume of the study group | Dietary Supplement: whey protein plus carbohydrate drink<br>* 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)<br>* Other names: Resource® Breeze - Nestlé, São Paulo, Brasil;|
| Experimental: whey protein plus carbohydrate<br>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<br>* 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)<br>* Other names: Resource® Breeze - Nestlé, São Paulo, Brasil;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| insulin resistance | Insulin resistance will be assessed by Homa-IR | Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| acute-phase response | Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein | Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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preoperative fasting, insulin resistance, carbohydrates, whey protein, inflammatory response