NCT01971229

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Dec 2013

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 23, 2013

Completed
6 days until next milestone

First Posted

Study publicly available on registry

October 29, 2013

Completed
1 month until next milestone

Study Start

First participant enrolled

December 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2014

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2015

Completed
Last Updated

August 17, 2018

Status Verified

August 1, 2018

Enrollment Period

10 months

First QC Date

October 23, 2013

Last Update Submit

August 15, 2018

Conditions

Insulin Resistance

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • Gastric emptying

    Change over 3 hours

Study Arms (2)

Carbohydrate

SHAM COMPARATOR

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 drinkOther: Whey protein based drink

Whey Protein

ACTIVE COMPARATOR

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 drinkOther: Whey protein based drink

Interventions

Carbohydrate based drinkOTHER

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

CarbohydrateWhey Protein
Whey protein based drinkOTHER

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

CarbohydrateWhey Protein

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • \- Healthy volunteer

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

HyperinsulinismGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic Diseases

Study Officials

  • Franco Carli, MD

    Montreal General Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Professor, Department of Anesthesia

Study Record Dates

First Submitted

October 23, 2013

First Posted

October 29, 2013

Study Start

December 1, 2013

Primary Completion

October 1, 2014

Study Completion

July 1, 2015

Last Updated

August 17, 2018

Record last verified: 2018-08

Locations

CA(1)