NCT04092049

Brief Summary

To investigate the effect of chewing lollipop on gastric volume and gastric emptying in healthy volunteers drinking water.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Oct 2019

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

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

September 15, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

September 17, 2019

Completed
1 month until next milestone

Study Start

First participant enrolled

October 21, 2019

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 22, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 22, 2019

Completed
Last Updated

April 17, 2020

Status Verified

April 1, 2020

Enrollment Period

2 months

First QC Date

September 15, 2019

Last Update Submit

April 15, 2020

Conditions

Gastric Emptying

Outcome Measures

Primary Outcomes (1)

  • half time of gastric emptying

    from drinking water to gastric volume return to half of top volume before drinking water,on an average of 2 hours

Secondary Outcomes (1)

  • time of gastric emptying

    from drinking water to gastric volume return to baseline before drinking water,on an average of 2 hours

Study Arms (2)

lollipop

EXPERIMENTAL
Other: lollipop

control

NO INTERVENTION

Interventions

lollipopOTHER

chewing lollipop for 10 minutes

lollipop

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Xijing Hospital

Xi'an, Shaanxi, 710032, China

Location

Related Publications (1)

  • Bouvet L, Loubradou E, Desgranges FP, Chassard D. Effect of gum chewing on gastric volume and emptying: a prospective randomized crossover study. Br J Anaesth. 2017 Nov 1;119(5):928-933. doi: 10.1093/bja/aex270.

    PMID: 29077816RESULT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

September 15, 2019

First Posted

September 17, 2019

Study Start

October 21, 2019

Primary Completion

December 22, 2019

Study Completion

December 22, 2019

Last Updated

April 17, 2020

Record last verified: 2020-04

Locations

CN(1)