SalivaNCT04670341
The Effect of Chewing the Tapioca Pearls in Bubble Tea Drinks
A study testing chewing tapioca pearls in bubble tea drinks and drink tea without chewing tapioca pearls in people with Saliva, run by Gadjah Mada University at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Saliva
- What is being tested?
- chewing tapioca pearls in bubble tea drinks and drink tea without chewing tapioca pearls
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 15 participants
- Where
- 1 siteIndonesia
- Study dates
- 17 Sep 2020to 17 Oct 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- good Oral Hygiene Index-Simplified (OHI-S) score
Who cannot join
- taking medication
- a history of dry mouth
- smoking
- systemic disease
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Faculty of Dentistry, Universitas Gadjah Mada
Yogyakarta, 55281
About this study
Official title: Quality Improvement of Saliva by Chewing Tapioca Pearls in Bubble Tea Drinks
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.
Read the 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.
- Conditions
- Saliva
- Being tested
- chewing tapioca pearls in bubble tea drinks, drink tea without chewing tapioca pearls
- Keywords
- bubble tea, salivary C-reactive protein, salivary calcium
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
chewing tapioca pearls in bubble tea drinksOther
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.).
drink tea without chewing tapioca pearlsOther
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.).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: drink tea without chewing tapioca pearls |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 3 days
Secondary outcomes (1)
Calcium (Ca) level
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
Measured: 3 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Dec 2020
- Study start17 Sep 2020
- Primary completion17 Oct 2020
- Study completion17 Oct 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for SalivaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- 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 pearl
- Masking
- None (open label)
- Enrolment
- 15 participants (actual)
Sponsor and investigators
- Lead sponsor
- Gadjah Mada University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Juni Handajani, Gadjah Mada University
- Investigators
- Juni Handajani, PhD, Principal investigator, Faculty of Dentistry, Universitas Gadjah Mada
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04670341
- Sponsor's protocol ID
- FKGUGM1
- Status last verified
- Dec 2020
- First submitted
- 9 Dec 2020
- Last updated
- 17 Dec 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 35387272
Study at a glance
From the registry record, last updated by the sponsor on 17 Dec 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Quality Improvement of Saliva by Chewing Tapioca Pearls in Bubble Tea Drinks
- ClinicalTrials.gov ID
- NCT04670341
- Acronym / sponsor ID
- FKGUGM1
- Conditions
- Saliva
- Keywords
- bubble tea, salivary C-reactive protein, salivary calcium
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 15 participants (actual)
- Lead sponsor
- Gadjah Mada UniversityUniversity, hospital or other
- Study start
- 17 Sep 2020 (actual)
- Primary completion
- 17 Oct 2020 (actual)
- Study completion
- 17 Oct 2020 (actual)
- First posted
- 17 Dec 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- 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 pearl
| Arm | Type | Receives |
|---|---|---|
| chewing tapioca pearls in the bubble tea drinks | Experimental | Other: chewing tapioca pearls in bubble tea drinksIn 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 |
| drink tea without chewing tapioca pearls | Placebo comparator | Other: drink tea without chewing tapioca pearlsIn the second week, the subjects drink tea without tapioca pearls as much as 100 ml for 5 minutes per day for 3 days. |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- good Oral Hygiene Index-Simplified (OHI-S) score
Key exclusion criteria (4 listed)
- taking medication
- a history of dry mouth
- smoking
- systemic disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| chewing tapioca pearls in bubble tea drinksSaliva 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.). | Other | chewing tapioca pearls in the bubble tea drinks |
| drink tea without chewing tapioca pearlsSaliva 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.). | Other | drink tea without chewing tapioca pearls |
Primary outcome
Salivary C-reactive protein (CRP) level
Time frame: 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
1 secondary outcome
Calcium (Ca) level
Time frame: 3 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Dec 2020.
- Derived from this study: PubMed 35387272Handajani 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.
- Elevated salivary C-reactive protein levels are associated with active and passive smoking in healthy youth: A pilot studyLink provided by the sponsor.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Juni Handajani, PhD principal investigator
Faculty of Dentistry, Universitas Gadjah Mada
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing chewing tapioca pearls in bubble tea drinks and drink tea without chewing tapioca pearls in people with Saliva, run by Gadjah Mada University at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 17 Dec 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Salivary C-reactive protein (CRP) level (time frame: 3 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04670341, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Dec 2020.