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
About this trial
This is an interventional basic science trial for Insulin Resistance
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.
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
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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