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

Primary Purpose

Acute Phase Response, Insulin Resistance

Status

Completed

Phase

Not Applicable

Locations

Brazil

Study Type

Interventional

Intervention

whey protein plus carbohydrate drink

About this trial

This is an interventional treatment trial for Acute Phase Response focused on measuring preoperative fasting, insulin resistance, carbohydrates, whey protein, inflammatory response

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Hospital Julio Muller

Arms of the Study

Arm 1

Arm 2

Arm Type

Placebo Comparator

Experimental

Arm Label

water

whey protein plus carbohydrate

Arm Description

Patients will receive water 3h before operation in the same volume of the study group

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)

Outcomes

Primary Outcome Measures

insulin resistance

Insulin resistance will be assessed by Homa-IR

Secondary Outcome Measures

acute-phase response

Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein

Full Information

NCT ID

NCT01354249

First Posted

May 10, 2011

Last Updated

May 13, 2011

Sponsor

Federal University of Mato Grosso

1. Study Identification

Unique Protocol Identification Number

NCT01354249

Brief Title

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

2. Study Status

Record Verification Date

May 2011

Overall Recruitment Status

Completed

Study Start Date

July 2010 (undefined)

Primary Completion Date

October 2010 (Actual)

Study Completion Date

October 2010 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor

Federal University of Mato Grosso

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Acute Phase Response, Insulin Resistance

Keywords

preoperative fasting, insulin resistance, carbohydrates, whey protein, inflammatory response

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Factorial Assignment

Masking

ParticipantCare ProviderInvestigator

Allocation

Randomized

Enrollment

20 (Actual)

8. Arms, Groups, and Interventions

Arm Title

water

Arm Type

Placebo Comparator

Arm Description

Patients will receive water 3h before operation in the same volume of the study group

Arm Title

whey protein plus carbohydrate

Arm Type

Experimental

Arm Description

Intervention Type

Dietary Supplement

Intervention Name(s)

whey protein plus carbohydrate drink

Other Intervention Name(s)

Resource® Breeze - Nestlé, São Paulo, Brasil

Intervention Description

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)

Primary Outcome Measure Information:

Title

insulin resistance

Description

Insulin resistance will be assessed by Homa-IR

Time Frame

Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation

Secondary Outcome Measure Information:

Title

acute-phase response

Description

Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein

Time Frame

Assays for the various acute-phase proteins will be done 2-3h before operation and 24 h after the operation

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

65 Years

Accepts Healthy Volunteers

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Jose Aguilar-Nascimento, D, PhD

Organizational Affiliation

Federal University of Mato Grosso

Official's Role

Principal Investigator

Facility Information:

Facility Name

Hospital Julio Muller

City

Cuiaba

State/Province

Mato Grosso

ZIP/Postal Code

78000-000

Country

Brazil

12. IPD Sharing Statement

Citations:

PubMed Identifier

21668975

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.

Results Reference

derived

Links:

URL

http://www.projetoacerto.com.br

Description

Projeto Acerto

Learn more about this trial

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

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