Gastric Emptying and Insulin Response to Test Drink

NCT ID: NCT01971229

Last Updated: 2018-08-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

15 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-12-31

Study Completion Date

2015-07-31

Brief Summary

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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

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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.

Conditions

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Insulin Resistance

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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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.

Group Type SHAM_COMPARATOR

Carbohydrate based drink

Intervention Type OTHER

After consumption of the test drink to record the insulin response and gastric emptying.

Whey protein based drink

Intervention Type OTHER

After consumption of the test drink to record the insulin response and gastric emptying.

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.

Group Type ACTIVE_COMPARATOR

Carbohydrate based drink

Intervention Type OTHER

After consumption of the test drink to record the insulin response and gastric emptying.

Whey protein based drink

Intervention Type OTHER

After consumption of the test drink to record the insulin response and gastric emptying.

Interventions

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Carbohydrate based drink

After consumption of the test drink to record the insulin response and gastric emptying.

Intervention Type OTHER

Whey protein based drink

After consumption of the test drink to record the insulin response and gastric emptying.

Intervention Type OTHER

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Franco Carli

OTHER

Sponsor Role lead

Responsible Party

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Franco Carli

Professor, Department of Anesthesia

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Franco Carli, MD

Role: PRINCIPAL_INVESTIGATOR

Montreal General Hospital

Locations

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Montreal General Hospital

Montreal, Quebec, Canada

Site Status

Countries

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Canada

Other Identifiers

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13-168-BMA

Identifier Type: -

Identifier Source: org_study_id

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