Lollipop on Gastric Volume

April 15, 2020 updated by: Zhihong LU, Air Force Military Medical University, China

Effect of Chewing Lollipop on Gastric Residual Volume

To observe the effect of chewing lollipop on residual gastric volume in healthy volunteers with fasting.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

20

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

  • China
    • Shaanxi
      • Xi'an, Shaanxi, China, 710032
        • Xijing Hospital

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 to 45 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • volunteer aged 18 years-45 years old
  • volunteer with a body mass index between 18 and 28 kg/m2

Exclusion Criteria:

  • those with history of diabetes mellitus
  • those with gastric diseases
  • those with history of gastro-intestinal surgery
  • those with history of smoking
  • those with use of gastric mobility medicines
  • those with pregnancy or breeding

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: Other
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
No Intervention: control
Experimental: lollipop
Other: lollipop
chewing lollipop for 20min

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
residual gastric volume at 30 minutes after chewing lollipop
Time Frame: from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes
from starting chewing lollipop to 30 minutes after chewing, on an average of 30 minutes

Secondary Outcome Measures

Outcome Measure
Time Frame
residual gastric volume at 2 hours after chewing lollipop
Time Frame: from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours
from starting chewing lollipop to 2 hours after chewing, on an average of 2 hours
residual gastric volume at 1 hour after chewing lollipop
Time Frame: residual gastric volume at 1 hour after chewing lollipop
residual gastric volume at 1 hour after chewing lollipop
time to peak gastric volume
Time Frame: from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour
from starting chewing lollipop to gastric volume reaching peak , on an average of 1 hour

Collaborators and Investigators

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

Sponsor

Air Force Military Medical University, China

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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)

October 21, 2019

Primary Completion (Actual)

December 22, 2019

Study Completion (Actual)

December 22, 2019

Study Registration Dates

First Submitted

September 16, 2019

First Submitted That Met QC Criteria

September 16, 2019

First Posted (Actual)

September 18, 2019

Study Record Updates

Last Update Posted (Actual)

April 17, 2020

Last Update Submitted That Met QC Criteria

April 15, 2020

Last Verified

April 1, 2020

More Information

Terms related to this study

Other Study ID Numbers

  • XJH-A-20190916-2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

Data of primary and secondary outcomes could be shared

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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