Insulin ResistanceNCT01971229
Gastric Emptying and Insulin Response to Test Drink
A study testing Carbohydrate based drink and Whey protein based drink in people with Insulin Resistance, run by Franco Carli at 1 site in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance
- What is being tested?
- Carbohydrate based drink and Whey protein based drink
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteCanada
- Study dates
- Dec 2013to Jul 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Healthy volunteer
Who cannot join
- diabetes,
- neurological disorders
- chronic kidney failure
- chronic liver disease
- disorders of gastric motility
- gastro-esophageal reflux
Show all 13Show fewer
- achalasia
- gastroparesis
- intestinal obstruction
- previous abdominal surgery
- lactose intolerance
- body mass index below 17 or above 29
- allergy to acetaminophen.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.
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.
Read the 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.
- Conditions
- Insulin Resistance
- Being tested
- Carbohydrate based drink, Whey protein based drink
- Medical subject headings
- Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Carbohydrate based drinkOther
After consumption of the test drink to record the insulin response and gastric emptying.
Whey protein based drinkOther
After consumption of the test drink to record the insulin response and gastric emptying.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Other: Carbohydrate based drink; Other: 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. Receives: Other: Carbohydrate based drink; Other: Whey protein based drink |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Change over 3 hours
Secondary outcomes (1)
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.
Measured: Change over 3 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2013 (estimated)
- Study startDec 2013
- Primary completionOct 2014
- Study completionJul 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Franco Carli
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Franco Carli, McGill University Health Centre/Research Institute of the McGill University Health Centre
- Investigators
- Franco Carli, MD, Principal investigator, Montreal General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01971229
- Sponsor's protocol ID
- 13-168-BMA
- Status last verified
- Aug 2018
- First submitted
- 23 Oct 2013
- Last updated
- 17 Aug 2018
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Insulin Response Following Ingestion of a Carbohydrate/Whey Protein Drink. A Cross-over Randomized Double Blind Study.
- ClinicalTrials.gov ID
- NCT01971229
- Acronym / sponsor ID
- 13-168-BMA
- Conditions
- Insulin Resistance
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Franco CarliUniversity, hospital or other
- Study start
- Dec 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Jul 2015 (actual)
- First posted
- 29 Oct 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Carbohydrate | Sham comparator | Other: Carbohydrate based drink, Other: Whey protein based drinkPatients 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. |
| Whey Protein | Active comparator | Other: Carbohydrate based drink, Other: Whey protein based drinkPatients 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. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Healthy volunteer
Key exclusion criteria (13 listed)
- diabetes,
- neurological disorders
- chronic kidney failure
- chronic liver disease
- disorders of gastric motility
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Carbohydrate based drinkAfter consumption of the test drink to record the insulin response and gastric emptying. | Other | Carbohydrate, Whey Protein |
| Whey protein based drinkAfter consumption of the test drink to record the insulin response and gastric emptying. | Other | Carbohydrate, Whey Protein |
Primary outcome
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.
1 secondary outcome
Gastric emptying
Time frame: Change over 3 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Aug 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Franco Carli, MD principal investigator
Montreal General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Carbohydrate based drink and Whey protein based drink in people with Insulin Resistance, run by Franco Carli at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Aug 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Insulin response to a test meal (time frame: Change over 3 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Aug 2018.