NCT04670341

Brief Summary

Bubble tea drinks contain tea and tapioca pearls. Chewing tapioca pearls in bubble tea drinks may increase salivary components. Because of its proteins, inorganic components, and enzymes, saliva plays an important role in the body's defense against bacteria and viruses. This study aims to analyze the effect of chewing the tapioca pearls in bubble tea drinks on salivary C-reactive protein (CRP) and calcium (Ca) levels.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2020

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

Study Start

First participant enrolled

September 17, 2020

Completed
1 month until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 17, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 17, 2020

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 9, 2020

Completed
8 days until next milestone

First Posted

Study publicly available on registry

December 17, 2020

Completed
Last Updated

December 17, 2020

Status Verified

December 1, 2020

Enrollment Period

1 month

First QC Date

December 9, 2020

Last Update Submit

December 15, 2020

Conditions

Keywords

bubble teasalivary C-reactive proteinsalivary calcium

Outcome Measures

Primary Outcomes (1)

  • Salivary C-reactive protein (CRP) level

    Salivary CRP level was measured on the first day before chewing tapioca peals in the bubble tea drinks and drink tea. Salivary CRP level was measured on the third day after drink bubble tea and tea without tapioca pearls

    3 days

Secondary Outcomes (1)

  • Calcium (Ca) level

    3 days

Study Arms (2)

chewing tapioca pearls in the bubble tea drinks

EXPERIMENTAL

In the first week, the subjects drink as much as 100 ml of bubble tea over a span of 5 minutes once a day for 3 days

Other: chewing tapioca pearls in bubble tea drinks

drink tea without chewing tapioca pearls

PLACEBO COMPARATOR

In the second week, the subjects drink tea without tapioca pearls as much as 100 ml for 5 minutes per day for 3 days.

Other: drink tea without chewing tapioca pearls

Interventions

Saliva was collected on the first day before bubble tea consumption (pretest) and on the third day after bubble tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).

chewing tapioca pearls in the bubble tea drinks

Saliva was collected on the first day before drink tea without tapioca pearl (pretest) and on the third day after tea consumption (posttest); collection was conducted in the morning (09:00 a.m.-12.00 p.m.).

drink tea without chewing tapioca pearls

Eligibility Criteria

Age18 Years - 25 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • good Oral Hygiene Index-Simplified (OHI-S) score

You may not qualify if:

  • taking medication
  • a history of dry mouth
  • smoking
  • systemic disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dentistry, Universitas Gadjah Mada

Yogyakarta, 55281, Indonesia

Location

Related Publications (1)

  • Handajani J, Kusumajati D, Fathiyah H, Susilowati H, Tandelilin RTC. Quality improvement of saliva by chewing tapioca pearls in bubble tea drinks: a randomized experimental trial: (Study on salivary C-reactive protein (CRP) and calcium (Ca) levels). F1000Res. 2021 Feb 1;10:56. doi: 10.12688/f1000research.28028.2. eCollection 2021.

Related Links

Study Officials

  • Juni Handajani, PhD

    Faculty of Dentistry, Universitas Gadjah Mada

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: In the first week of the experiment, subject chewing tapioca pearl inthe bubble tea. In the second week, the same subjects drink tea without chewing tapioca pearl
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Quality improvement of saliva by chewing tapioca pearls in bubble tea drinks

Study Record Dates

First Submitted

December 9, 2020

First Posted

December 17, 2020

Study Start

September 17, 2020

Primary Completion

October 17, 2020

Study Completion

October 17, 2020

Last Updated

December 17, 2020

Record last verified: 2020-12

Data Sharing

IPD Sharing
Will not share

Locations