Gastric Emptying of Maltodextrin Solution in Elderly and in Adults (GEMA)

February 26, 2020 updated by: Gabriel Magalhaes Nunes Guimaraes, Brasilia University Hospital

Gastric Emptying of Maltodextrin Solution in Elderly and in Adults: Clinical Trial

Gastric volume will be measured before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Detailed Description

Gastric volume will be estimated before, 5, 30, 60, 90 and 120 min after drinking 450ml of maltodextrin in young adults and elderly using antral ultrasound.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Not Applicable

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
    • Distrito Federal
      • Brasilia, Distrito Federal, Brazil, 700000000
        • Hospital das Forças Armadas

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

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • ASA physical status I or II;
  • No known risk factor for slow or fast gastric emptying.

Exclusion Criteria:

  • Vomiting the study solution before completion.
  • Wrong timing of assessment.
  • Protocol violation.

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: DIAGNOSTIC
  • Allocation: NON_RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
ACTIVE_COMPARATOR: Adults
Adults < 60 years-old maltodextrin solution 450ml
Dietary supplement: maltodextrin
maltodextrin solution 450ml
ACTIVE_COMPARATOR: Elders
Elders 65 or more years-old maltodextrin solution 450ml
Dietary supplement: maltodextrin
maltodextrin solution 450ml

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Antral Volume change
Time Frame: Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)
Antral volume in cm² assessed by ultrasound in semirecumbent position.
Just before and 5, 30, 60, 90 and 120 minutes after drinking the study solution (repeated measures)

Collaborators and Investigators

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

Sponsor

Brasilia University Hospital

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 (ACTUAL)

January 1, 2020

Primary Completion (ANTICIPATED)

April 1, 2020

Study Completion (ANTICIPATED)

July 1, 2020

Study Registration Dates

First Submitted

February 26, 2020

First Submitted That Met QC Criteria

February 26, 2020

First Posted (ACTUAL)

February 28, 2020

Study Record Updates

Last Update Posted (ACTUAL)

February 28, 2020

Last Update Submitted That Met QC Criteria

February 26, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • tccandre2020

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Plan to Share in Online Data Sharing Platform.

IPD Sharing Time Frame

We will put SAP and Analytic code in RPubs for as long as RPubs exists. Study protocol and ICF will be published in ClinicalTrials

IPD Sharing Access Criteria

Open

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF
  • ANALYTIC_CODE

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

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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