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Completed

NCT Number: NCT01971229

Gastric Emptying and Insulin Response to Test Drink

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Montreal General Hospital

Montreal, Quebec, H3G 1A4, Canada

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Carbohydrate based drink

Other

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

Whey protein based drink

Other

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

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

Sponsors and collaborators

Lead sponsor

Franco Carli

Other

Registry information

Official study title

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

Important dates

Study start
2013
Primary completion
2014
Study completion
2015
First posted
Oct 29, 2013
Registry last updated
Aug 17, 2018

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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