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
Sponsored by
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
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
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)
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
No
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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