NCT03567915

Brief Summary

The investigators evaluate gastric emptying time of common Korean meals (rice, noodles) in healthy volunteers.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
60

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jun 2018

Shorter than P25 for all trials

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 4, 2018

Completed
1 month until next milestone

Study Start

First participant enrolled

June 15, 2018

Completed
11 days until next milestone

First Posted

Study publicly available on registry

June 26, 2018

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2019

Completed
Last Updated

June 26, 2018

Status Verified

June 1, 2018

Enrollment Period

11 months

First QC Date

May 4, 2018

Last Update Submit

June 22, 2018

Conditions

Outcome Measures

Primary Outcomes (1)

  • Gastric emptying time

    The time for digesting a meal

    1 hour

Secondary Outcomes (4)

  • Incidence of full stomach

    At 4, 5, 6, 7, and 8 hours after eating a meal.

  • Cross sectional area of the stomach

    At 4, 5, 6, 7, and 8 hours after eating a meal.

  • Gastric volume

    At 4, 5, 6, 7, and 8 hours after eating a meal.

  • Type of gastric contents

    At 4, 5, 6, 7, and 8 hours after eating a meal.

Study Arms (2)

Rice

Group that healthy volunteers eat rice.

Other: Evaluation of gastric volume and content

Noodle

Group that healthy volunteers eat noodle.

Other: Evaluation of gastric volume and content

Interventions

The gastric volume and gastric content are assessed at 4, 5, 6, 7, and 8 hours after eating a meal.

NoodleRice

Eligibility Criteria

Age20 Years+
Sexall
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Adult healthy volunteers

You may qualify if:

  • Adult healthy volunteers

You may not qualify if:

  • History of gastrectomy
  • Anatomical abnormalities or mass of stomach

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Dr

Study Record Dates

First Submitted

May 4, 2018

First Posted

June 26, 2018

Study Start

June 15, 2018

Primary Completion

May 1, 2019

Study Completion

May 1, 2019

Last Updated

June 26, 2018

Record last verified: 2018-06