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Gastric Emptying and Insulin Response to Test Drink

Primary Purpose

Insulin Resistance

Status
Completed
Phase
Not Applicable
Locations
Canada
Study Type
Interventional
Intervention
Carbohydrate based drink
Whey protein based drink
Sponsored by
Franco Carli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Insulin Resistance

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Montreal General Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Active Comparator

Arm Label

Carbohydrate

Whey Protein

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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.

Full Information

First Posted
October 23, 2013
Last Updated
August 15, 2018
Sponsor
Franco Carli
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1. Study Identification

Unique Protocol Identification Number
NCT01971229
Brief Title
Gastric Emptying and Insulin Response to Test Drink
Official Title
Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.
Study Type
Interventional

2. Study Status

Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
December 2013 (undefined)
Primary Completion Date
October 2014 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Franco Carli

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Insulin Resistance

7. Study Design

Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
15 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Carbohydrate
Arm Type
Sham Comparator
Arm Description
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.
Arm Title
Whey Protein
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Other
Intervention Name(s)
Carbohydrate based drink
Intervention Description
After consumption of the test drink to record the insulin response and gastric emptying.
Intervention Type
Other
Intervention Name(s)
Whey protein based drink
Intervention Description
After consumption of the test drink to record the insulin response and gastric emptying.
Primary Outcome Measure Information:
Title
Insulin response to a test meal
Description
Patients will consume a carbohydrate or a whey protein based drink and their insulin response will be monitored every 30 minutes for 3 hours.
Time Frame
Change over 3 hours
Secondary Outcome Measure Information:
Title
Gastric emptying
Description
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.
Time Frame
Change over 3 hours

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Franco Carli, MD
Organizational Affiliation
Montreal General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Montreal General Hospital
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H3G 1A4
Country
Canada

12. IPD Sharing Statement

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Gastric Emptying and Insulin Response to Test Drink

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