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The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks

Sponsor
Gadjah Mada University (Other)
Overall Status
Completed
CT.gov ID
NCT04670341
Collaborator
(none)
15
Enrollment
1
Location
2
Arms
30
Actual Duration (Days)
15.2
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Other: chewing tapioca pearls in bubble tea drinks
  • Other: drink tea without chewing tapioca pearls
 N/A

Detailed Description

Sixty saliva samples were collected from 15 subjects. The inclusion criterion was 18-25 years of age. The exclusion criteria were receiving medication, using dentures, a history of dry mouth, smoking and systemic disease. In the first week of the experiment, subjects drank bubble tea as the intervention group. In the second week, the same subjects drank tea without pearls as the control group. Each subject drank the bubble tea for 5 minutes per day over 3 days. Saliva samples were collected on the first day before bubble tea consumption (pretest) and on the third day after tea consumption (posttest). Saliva collection was performed in the morning (09:00 a.m.-12:00 p.m.) for 1 minute. Salivary CRP levels were measured using an ELISA kit, and Ca levels were determined using a test kit.

Study Design

Study Type:
Interventional
Actual Enrollment :
15 participants
Allocation:
Non-Randomized
Intervention Model:
Crossover Assignment
Intervention Model Description:
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 pearlIn 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
Masking:
None (Open Label)
Primary Purpose:
Basic Science
Official Title:
Quality Improvement of Saliva by Chewing Tapioca Pearls in Bubble Tea Drinks
Actual Study Start Date :
Sep 17, 2020
Actual Primary Completion Date :
Oct 17, 2020
Actual Study Completion Date :
Oct 17, 2020

Arms and Interventions

Arm Intervention/Treatment
Experimental: chewing tapioca pearls in the bubble tea drinks

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
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.).
Placebo Comparator: drink tea without chewing tapioca pearls

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
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.).

Outcome Measures

Primary Outcome Measures

  1. Salivary C-reactive protein (CRP) level [3 days]

    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

Secondary Outcome Measures

  1. Calcium (Ca) level [3 days]

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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years to 25 Years
Sexes Eligible for Study:
All
Accepts Healthy Volunteers:
Yes
Inclusion Criteria:
  • good Oral Hygiene Index-Simplified (OHI-S) score
Exclusion Criteria:

  • taking medication

  • a history of dry mouth

  • smoking

  • systemic disease

Contacts and Locations

Locations

Site City State Country Postal Code
1 Faculty of Dentistry, Universitas Gadjah Mada Yogyakarta Indonesia 55281

Sponsors and Collaborators

  • Gadjah Mada University

Investigators

  • Principal Investigator: Juni Handajani, PhD, Faculty of Dentistry, Universitas Gadjah Mada

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Juni Handajani, Quality improvement of saliva by chewing tapioca pearls in bubble tea drinks, Gadjah Mada University
ClinicalTrials.gov Identifier:
NCT04670341
Other Study ID Numbers:
  • FKGUGM1
First Posted:
Dec 17, 2020
Last Update Posted:
Dec 17, 2020
Last Verified:
Dec 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Product Manufactured in and Exported from the U.S.:
Yes
Keywords provided by Juni Handajani, Quality improvement of saliva by chewing tapioca pearls in bubble tea drinks, Gadjah Mada University
bubble tea
salivary C-reactive protein
salivary calcium

Study Results

No Results Posted as of Dec 17, 2020