Gastric Emptying and Insulin Response to Test Drink

Insulin Resistance Clinical Trial

Official title:

Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01971229
• Other study ID #: 13-168-BMA
• Status: Completed
• Phase: N/A
• Start date: December 2013
• Est. completion date: July 2015

Study information

• Verified date: August 2018
• Source: McGill University Health Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 15
• Est. completion date: July 2015
• Est. primary completion date: October 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 70 Years

Eligibility

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.

Related Conditions & MeSH terms

• Insulin Resistance

Intervention

Other:
• 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.

Locations

Country	Name	City	State
Canada	Montreal General Hospital	Montreal	Quebec

Sponsors (1)

Lead Sponsor	Collaborator
Franco Carli

Country where clinical trial is conducted

Canada, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Insulin response to a test meal	Patients will consume a carbohydrate or a whey protein based drink and their insulin response will be monitored every 30 minutes for 3 hours.	Change over 3 hours
Secondary	Gastric emptying	The acetaminophen absorption test, as an indirect assessment of gastric emptying.Since gastric emptying is the rate-limiting step in delivering the drug to its absorption site, it is believed that the rate of appearance of acetaminophen in the blood reflects the rate of gastric emptying.; Blood samples will be collected every 30 minutes for 3 hours.	Change over 3 hours