Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance
This study has been completed.
Sponsor:
Federal University of Mato Grosso do Sul
Information provided by:
Federal University of Mato Grosso do Sul
ClinicalTrials.gov Identifier:
NCT01354249
First received: May 10, 2011
Last updated: May 13, 2011
Last verified: May 2011
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Acute Phase Response Insulin Resistance |
Dietary Supplement: whey protein plus carbohydrate drink |
| Study Type: | Interventional |
| Study Design: | Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Factorial Assignment Masking: Double Blind (Subject, Caregiver, Investigator) Primary Purpose: Treatment |
| Official Title: | Effects of Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance. |
Resource links provided by NLM:
MedlinePlus related topics:
Diabetes Medicines
Drug Information available for:
Insulin human
U.S. FDA Resources
Further study details as provided by Federal University of Mato Grosso do Sul:
Primary Outcome Measures:
- insulin resistance [ Time Frame: Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation ] [ Designated as safety issue: No ]Insulin resistance will be assessed by Homa-IR
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein
| Enrollment: | 20 |
| Study Start Date: | July 2010 |
| Study Completion Date: | October 2010 |
| Primary Completion Date: | October 2010 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo Comparator: water
Patients will receive water 3h before operation in the same volume of the study group
|
Dietary Supplement: whey protein plus carbohydrate drink
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 Name: Resource® Breeze - Nestlé, São Paulo, Brasil
|
|
Experimental: whey protein plus carbohydrate
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
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 Name: Resource® Breeze - Nestlé, São Paulo, Brasil
|
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
Eligibility| Ages Eligible for Study: | 18 Years to 65 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01354249
Locations
| Brazil | |
| Hospital Julio Muller | |
| Cuiaba, Mato Grosso, Brazil, 78000-000 | |
Sponsors and Collaborators
Federal University of Mato Grosso do Sul
Investigators
| Principal Investigator: | Jose Aguilar-Nascimento, D, PhD | Federal University of Mato Grosso do Sul |
More Information
Additional Information:
No publications provided by Federal University of Mato Grosso do Sul
Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
| Responsible Party: | Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso |
| ClinicalTrials.gov Identifier: | NCT01354249 History of Changes |
| Other Study ID Numbers: | fperrone |
| Study First Received: | May 10, 2011 |
| Last Updated: | May 13, 2011 |
| Health Authority: | Brazil: Ethics Committee |
Keywords provided by Federal University of Mato Grosso do Sul:
|
preoperative fasting insulin resistance carbohydrates whey protein inflammatory response |
Additional relevant MeSH terms:
|
Acute-Phase Reaction Insulin Resistance Inflammation Pathologic Processes Hyperinsulinism Glucose Metabolism Disorders |
Metabolic Diseases Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013