Gastric Emptying and Insulin Response to Test Drink

August 15, 2018 updated by: Franco Carli

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

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed 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.

Study Type

Interventional

Enrollment (Actual)

15

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Quebec
      • Montreal, Quebec, Canada, H3G 1A4
        • Montreal General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Sham Comparator: Carbohydrate
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.
Other: Carbohydrate based drink
After consumption of the test drink to record the insulin response and gastric emptying.
Other: Whey protein based drink
After consumption of the test drink to record the insulin response and gastric emptying.
Active Comparator: Whey Protein
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.
Other: Carbohydrate based drink
After consumption of the test drink to record the insulin response and gastric emptying.
Other: Whey protein based drink
After consumption of the test drink to record the insulin response and gastric emptying.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin response to a test meal
Time Frame: Change over 3 hours
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 Outcome Measures

Outcome Measure
Measure Description
Time Frame
Gastric emptying
Time Frame: Change over 3 hours

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Franco Carli

Investigators

  • Principal Investigator: Franco Carli, MD, Montreal General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2013

Primary Completion (Actual)

October 1, 2014

Study Completion (Actual)

July 1, 2015

Study Registration Dates

First Submitted

October 23, 2013

First Submitted That Met QC Criteria

October 28, 2013

First Posted (Estimate)

October 29, 2013

Study Record Updates

Last Update Posted (Actual)

August 17, 2018

Last Update Submitted That Met QC Criteria

August 15, 2018

Last Verified

August 1, 2018

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 13-168-BMA

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Insulin Resistance

Clinical Trials on Carbohydrate based drink

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Oman

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

3
Subscribe