Preoperative Feeding With a Whey Protein Plus Carbohydrate Drink on the Acute Phase Response and Insulin Resistance
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ClinicalTrials.gov Identifier: NCT01354249 |
Recruitment Status
:
Completed
First Posted
: May 16, 2011
Last Update Posted
: May 16, 2011
|
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Condition or disease | Intervention/treatment | Phase |
---|---|---|
Acute Phase Response Insulin Resistance | Dietary Supplement: whey protein plus carbohydrate drink | Not Applicable |
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
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 20 participants |
Allocation: | Randomized |
Intervention Model: | Factorial Assignment |
Masking: | Triple (Participant, Care Provider, 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. |
Study Start Date : | July 2010 |
Actual Primary Completion Date : | October 2010 |
Actual Study Completion Date : | October 2010 |

Arm | Intervention/treatment |
---|---|
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
|
- insulin resistance [ Time Frame: Homa-IR will be assessed in two time points: baseline (2-3 h before operatio) and 24h after operation ]Insulin resistance will be assessed by Homa-IR
- 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 ]Assays for albumin, pre-albumin, C reactive protein and α-1-acid glycoprotein

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Ages Eligible for Study: | 18 Years to 65 Years (Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | No |
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.

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01354249
Brazil | |
Hospital Julio Muller | |
Cuiaba, Mato Grosso, Brazil, 78000-000 |
Principal Investigator: | Jose Aguilar-Nascimento, D, PhD | Federal University of Mato Grosso do Sul |
Additional Information:
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 |
First Posted: | May 16, 2011 Key Record Dates |
Last Update Posted: | May 16, 2011 |
Last Verified: | May 2011 |
Keywords provided by Federal University of Mato Grosso do Sul:
preoperative fasting insulin resistance carbohydrates whey protein inflammatory response |
Additional relevant MeSH terms:
Insulin Resistance Acute-Phase Reaction Hyperinsulinism Glucose Metabolism Disorders Metabolic Diseases |
Inflammation Pathologic Processes Insulin Hypoglycemic Agents Physiological Effects of Drugs |