Overview

This trial is active, not recruiting.

Condition insulin resistance
Treatments carbohydrate based drink, whey protein based drink
Sponsor Franco Carli
Start date December 2013
End date October 2014
Trial size 20 participants
Trial identifier NCT01971229, 13-168-BMA

Summary

Surgery is a stress on the body and recovering well after surgery is very important to patients and their doctors. It is therefore important to prepare patient's bodies for the stress of surgery, and one way to do this is to provide proper nutrition. In the past, patients were asked to prepare for surgery by fasting from midnight before surgery. Today, it is known that this practice is not beneficial to patient's recovery. In fact, it has been recognized that drinking a sugary beverage (e.g., juice) before surgery stimulates the production of insulin, which is a hormone that helps make the proteins needed for wound healing after surgery. This is currently practiced at the MUHC. It might also be beneficial, however, to drink a beverage that contains sugar and whey proteins (a protein isolated from milk) before surgery. In fact, whey proteins stimulate insulin and may also have the added benefit of improving muscular strength. In this study, investigators will measure the level of insulin produced after drinking a carbohydrate (i.e., sugar)-whey protein beverage to determine how it compares to the level of insulin produced after drinking the sugary beverage used at the MUHC.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Intervention model crossover assignment
Masking double blind (subject, investigator)
Primary purpose basic science
Arm
(Sham Comparator)
Patients in this arm will drink a 425 mL 100% clear apple juice (carbohydrate 50 g, 700 mOsmol). 1.5 g of acetaminophen will be dissolved in the beverage for determination of gastric emptying.
carbohydrate based drink
After consumption of the test drink to record the insulin response and gastric emptying.
whey protein based drink
After consumption of the test drink to record the insulin response and gastric emptying.
(Active Comparator)
Patients in this arm will drink a 330 mL Boost fruit flavoured clear beverage (whey protein 12.2 g, carbohydrate 50 g, 700 mOsmol).1.5 g of acetaminophen will be dissolved in the beverage for determination of gastric emptying.
carbohydrate based drink
After consumption of the test drink to record the insulin response and gastric emptying.
whey protein based drink
After consumption of the test drink to record the insulin response and gastric emptying.

Primary Outcomes

Measure
Insulin response to a test meal
time frame: Change over 3 hours

Secondary Outcomes

Measure
Gastric emptying
time frame: Change over 3 hours

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

Inclusion Criteria: - Healthy volunteer Exclusion Criteria: - diabetes, - neurological disorders - chronic kidney failure - chronic liver disease - disorders of gastric motility - gastro-esophageal reflux - achalasia - gastroparesis - intestinal obstruction - previous abdominal surgery - lactose intolerance - body mass index below 17 or above 29 - allergy to acetaminophen.

Additional Information

Official title Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.
Principal investigator Franco Carli, MD
Description It is hypothesized that the increase in plasma insulin following a mixed carbohydrate whey protein drink is significantly greater than that elicited by a carbohydrate drink.
Trial information was received from ClinicalTrials.gov and was last updated in November 2014.
Information provided to ClinicalTrials.gov by McGill University Health Center.