Safety of Gastric Volume Emptying After the Intake of Maltodextrin and Glutamine

February 22, 2013 updated by: Jose Eduardo de Aguilar-Nascimento, Federal University of Mato Grosso

Gastric Residual Volume After He Intake Of Maltodextrin And Glutamine. A Randomized Double-Blind, Crossover Study

Carbohydrates (CHO)-based drinks 2h before the induction of anesthesia are recommended to decrease insulin resistance. The addition of glutamine (GLN) in these beverages may enhance the benefits of CHO alone. However, only a few studies tested the safety of this formula. The objective of this study was to evaluate the gastric residual volume (GRV) after the intake of a beverage containing CHO plus GLN using magnetic resonance (MRI).

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

We included 11 male young volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months. The criteria for exclusion were non-adherence to any phase of the study protocol, gastroesophageal reflux disease, previous history of intolerance to lactose, gastroparesis or history of poor gastric emptying, diabetes mellitus, and previous abdominal surgery.

Each volunteer was randomized for participation in the study in a blind fashion. All subjects underwent two different protocols before MRI with an interval of seven days between them. Both phases took place after an overnight fast of eight hours. The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing either water plus 12.5% maltodextrin (Phloraceae, Cuiabá, Brazil; CHO group) or the same beverage plus 15g of GLN (Phloraceae, Cuiabá, Brazil; GLN group). The participants were instructed not to ingest alcohol, medication, and caffeine within 24 hours of the study, nor do any vigorous physical activity during that time.

In both phases the individuals were blind to the specific drink and they were told to ingest the beverage in a maximum period of five minutes and T0 was defined as the moment they complete the intake of the solution.The powdered products (maltodextrin alone or maltodextrine plus glutamine) were packed in coded opaque sachets and the content was only known by the pharmacist who manipulated it.

All the participants in the study underwent magnetic resonance of the upper abdomen at 12:00AM and 01:00PM. The GRV observed during the first exam was defined as T120 and the second exam as T180. All exams were performed by the same magnetic resonance equipment (Intera 1.5T ; Philips Healthcare, Eindhoven, Holland).

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
11

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
    • Mato Grosso
      • Cuiaba, Mato Grosso, Brazil, 78000-000
        • Hospital Santa Rosa

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

21 years to 30 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Young male volunteers (aged between 21 and 30 years-old) with body mass index (BMI) between 20 and 29 kg/m2 and without either acute or chronic illness in the last 3 months.

Exclusion Criteria:

  • non-adherence to any phase of the study protocol,
  • gastroesophageal reflux disease,
  • previous history of intolerance to lactose,
  • gastroparesis or history of poor gastric emptying,
  • diabetes mellitus, and
  • previous abdominal surgery

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: Maltodextrin
The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin
Dietary supplement: Maltodextrin
The volunteers underwent MRI after the ingestion of the dietary supplement in a crossover fashion aiming at measuring the gastric residual volume
Other Names:
  • Maltodestrin plus glutamine
Experimental: Glutamine
The same volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of glutamine
Dietary supplement: Glutamine
The volunteers ingested 400ml (4 hours before the exam was carried out) at 8:00AM and 200ml (2 hours before the exam was carried out) at 10:00AM of a beverage containing water plus 12.5% maltodextrin plus 15g of GLN before MRI

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Gastric residual volume (GVR) ("change" is being assessed)
Time Frame: immediately after ingestion (T0), 120 minutes after (T120) and 180 (T180) minutes after ingestion
We measured the GRV by MRI immediately after ingestion (T0)and the changes of GVR after 120 (T120)and 180 minutes (T180)- "change" is being assessed
immediately after ingestion (T0), 120 minutes after (T120) and 180 (T180) minutes after ingestion

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
Vomiting
Time Frame: 180 minutes
We observed whether the volunteer presented vomiting during the experiment
180 minutes

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Federal University of Mato Grosso

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 1, 2012

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 1, 2012

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
February 19, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 25, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
February 25, 2013

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
February 22, 2013

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
February 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • brianez

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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