NCT01354249

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

July 1, 2010

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2010

Completed
7 months until next milestone

First Submitted

Initial submission to the registry

May 10, 2011

Completed
6 days until next milestone

First Posted

Study publicly available on registry

May 16, 2011

Completed
Last Updated

May 16, 2011

Status Verified

May 1, 2011

Enrollment Period

3 months

First QC Date

May 10, 2011

Last Update Submit

May 13, 2011

Conditions

Acute Phase ResponseInsulin Resistance

Keywords

preoperative fastinginsulin resistancecarbohydrateswhey proteininflammatory response

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • acute-phase response

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

Study Arms (2)

water

PLACEBO COMPARATOR

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

Dietary Supplement: whey protein plus carbohydrate drink

whey protein plus carbohydrate

EXPERIMENTAL

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

Interventions

whey protein plus carbohydrate drinkDIETARY_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)

Also known as: Resource® Breeze - Nestlé, São Paulo, Brasil
waterwhey protein plus carbohydrate

Eligibility Criteria

Age18 Years - 65 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Adults (18-65 years-old)
  • Both sexes
  • Candidates to elective moderate operations such as open cholecystectomy, laparoscopic cholecystectomy and unilateral repair of inguinal hernia).

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Hospital Julio Muller

Cuiabá, Mato Grosso, 78000-000, Brazil

Location

Related Publications (1)

  • 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.

    PMID: 21668975DERIVED

Related Links

MeSH Terms

Conditions

Acute-Phase ReactionInsulin Resistance

Interventions

Whey Proteins

Condition Hierarchy (Ancestors)

InflammationPathologic ProcessesPathological Conditions, Signs and SymptomsHyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Milk ProteinsAnimal Proteins, DietaryDietary ProteinsProteinsAmino Acids, Peptides, and ProteinsWheyMilkDairy ProductsFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Jose Aguilar-Nascimento, D, PhD

    Federal University of Mato Grosso

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
FACTORIAL
Sponsor Type
OTHER

Study Record Dates

First Submitted

May 10, 2011

First Posted

May 16, 2011

Study Start

July 1, 2010

Primary Completion

October 1, 2010

Study Completion

October 1, 2010

Last Updated

May 16, 2011

Record last verified: 2011-05

Locations

BR(1)