CariesNCT05211843
Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries
A study testing Drinking water and Apple juice in people with Caries and Metabolomic Profile, run by Jodi Stookey at 1 site in United States.
Trial summary
Saliva insulin shows promise as a non-invasive biomarker of high carbohydrate intake and/or insulin resistance, key risk factors for metabolic dysregulation and caries. Saliva insulin monitoring could potentially inform the planning and evaluation of interventions to prevent child obesity, diabetes and caries, without… Read more about this study
- Who is it for?
- Ages 5 to 10 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries, Metabolomic Profile
- What is being tested?
- Drinking water and Apple juice
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 105 participants
- Where
- 1 siteUnited States
- Study dates
- 12 Oct 2022to 29 Jan 2024
- 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 5 to 10 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- UCSF Pediatric Dental Clinic patients New patient exam or recall exams Caregiver and child speak English, Spanish or Chinese Ages 5-10 years San Francisco residents Non-acutely ill (healthy enough to attend school, no fever and no systemic conditions)
Who cannot join
- Child and caregiver do not speak English, Spanish or Chinese Not a San Francisco resident Under age 5 years Over age 10 years Child unwilling to accept randomized drink assignment Child unable or unwilling to drink water or apple juice Child unable or unwilling to give saliva Child is presenting to the dental clinic for an operative procedure Acute illness, fever, infection or condition that would prevent the child from attending school No remaining space in study group (weight-specific recruitment is complete).
Trial locations and contacts
1 site in 1 country.
United States1 site
UCSF Pediatric Dentistry
San Francisco, California, 94143
About this study
Official title: Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries Which Can be Limited by Drinking Water Intervention in Elementary School Age Children
Saliva insulin shows promise as a non-invasive biomarker of high carbohydrate intake and/or insulin resistance, key risk factors for metabolic dysregulation and caries.
Saliva insulin monitoring could potentially inform the planning and evaluation of interventions to prevent child obesity, diabetes and caries, without relying on self-reported measures from children, parents, child care providers or teachers.
Read more
School-based public health screening programs, which have staff and data collection infrastructure in place to regularly and systematically collect saliva during oral health screening, have opportunity to monitor saliva insulin.
This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention. Public health programs may justify adding saliva collection to protocol already in place if saliva insulin data are found to be actionable, i.e. sensitive to risk and intervention.
Read the detailed description
This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention.
The specific aims of this randomized controlled trial are to:
Determine if the standard serving (500 ml) of drinking water normalizes saliva insulin to a greater extent, within 60 min, than no beverage or a standard serving (200 ml) apple juice in elementary school age children.
Determine if, in line with lower saliva insulin, 500 ml drinking water significantly alters macronutrient metabolism, within 60 min, relative to no beverage or 200 ml apple juice.
Determine if 500 ml drinking water reduces caries risk factors, improves saliva osmolality, pH, buffering capacity and immune response to a greater extent, within 60 min, than no beverage or 200 ml apple juice.
- Conditions
- Caries, Metabolomic Profile
- Being tested
- Drinking water, Apple juice
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Drinking waterOther
The intervention will compare the effects of a usual serving of drinking water with the effects of a usual serving of apple juice. Both beverages will also be assessed relative to the effects of not drinking anything at all.
Apple juiceOther
apple juice
| Study group | Role | What they receive |
|---|---|---|
| No drink | No intervention | Control; Participants will receive no drink |
| Drinking water | Experimental | Intervention drink; Participants will receive 500 ml drinking water from the San Francisco tap (i.e. fluoridated tap water). 500 ml is the standard bottle size. Receives: Other: Drinking water |
| Apple juice | Active comparator | Intervention drink; Participants will receive 200 ml box of apple juice. 200 ml is the standard serving usually available to this study population in the school setting Receives: Other: Apple juice |
What is being measured
The primary outcome is the main question the study is designed to answer.
Lower saliva insulin after drinking water compared to juice; compared to no drink
Lower mean saliva insulin; Greater relative odds of saliva insulin below 5mU/I
Measured: 1 hour
Secondary outcomes (4)
Different untargeted metabolomic profile after drinking water compared to juice; and after drinking water compared to no drink
The metabolomic profile will be measured by Untargeted Profiling of Primary Metabolism by mass spectrometry at the University of California Davis West Coast Metabolomics Center. Metabolomic data analyses will be done on data normalized by creatinine, log transformed, and mean centered using metaboanalyst software. The metabolomic profiles will be evaluated using Orthogonal Partial Least Squares Discriminant Analysis 2-D score plots and Principal Components Analysis score plots. Both types of analyses are required because each has limitations. This study hypothesizes that in both types of analysis, the 95% confidence ellipse for the saliva metabolomic profile after drinking water does not overlap the 95% confidence ellipse for the metabolomic profile after apple juice; nor does it overlap the 95% confidence ellipse after no drink.
Measured: 1 hour
Higher saliva pH (potential of hydrogen) after drinking water than after apple juice or no drink
Mean change in saliva pH from baseline to 1 hour after drinking water is significantly more positive than the mean change in saliva pH after apple juice (anticipating a decrease in saliva pH following the apple juice drink)
Measured: 1 hour
Higher saliva buffering capacity after drinking water than after apple juice or no drink
Greater relative odds of not having 'low' saliva buffering capacity after drinking water compared to apple juice, with 'low' as defined by the CRT buffer capacity test (Ivoclar, Vivadent, Schaan, Liechtenstein); similarly greater odds of not having 'low' buffering capacity after drinking water vs no drink; Greater odds of an improvement in buffering capacity classification (change from baseline to 1 hour after drink treatment) after drinking water compared to apple juice or no drink
Measured: 1 hour
Significantly higher saliva secretory immunoglobin a (IgA) after drinking water than after apple juice or no drink
Mean change in saliva IgA concentration from baseline to 1 hour after drinking water
Measured: 1 hour
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jan 2022
- Study start12 Oct 2022
- Primary completion31 Dec 2023
- Study completion29 Jan 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for CariesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Three randomly assigned groups, with randomization stratified by weight status, with measurements at baseline and post-intervention
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 105 participants (actual)
Sponsor and investigators
- Lead sponsor
- Jodi Stookey
- Sponsor type
- Other government
- Responsible party
- Sponsor-investigator, Jodi Stookey, San Francisco Department of Public Health
- Investigators
- Jodi Stookey, PhD, Principal investigator, San Francisco Department of Public HealthThomas Tanbonliong, DDS, Principal investigator, University of California, San FranciscoMimansa Cholera, DDS, Principal investigator, University of California, San Francisco
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05211843
- Sponsor's protocol ID
- Saliva insulin biomarker
- Status last verified
- Feb 2026
- First submitted
- 17 Dec 2021
- Last updated
- 25 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries Which Can be Limited by Drinking Water Intervention in Elementary School Age Children
- ClinicalTrials.gov ID
- NCT05211843
- Acronym / sponsor ID
- Saliva insulin biomarker
- Conditions
- Caries, Metabolomic Profile
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 105 participants (actual)
- Lead sponsor
- Jodi StookeyOther government
- Study start
- 12 Oct 2022 (actual)
- Primary completion
- 31 Dec 2023 (actual)
- Study completion
- 29 Jan 2024 (actual)
- First posted
- 27 Jan 2022 (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.
Saliva insulin shows promise as a non-invasive biomarker of high carbohydrate intake and/or insulin resistance, key risk factors for metabolic dysregulation and caries.
Saliva insulin monitoring could potentially inform the planning and evaluation of interventions to prevent child obesity, diabetes and caries, without relying on self-reported measures from children, parents, child care providers or teachers.
School-based public health screening programs, which have staff and data collection infrastructure in place to regularly and systematically collect saliva during oral health screening, have opportunity to monitor saliva insulin.
This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention. Public health programs may justify adding saliva collection to protocol already in place if saliva insulin data are found to be actionable, i.e. sensitive to risk and intervention.
Detailed description
This randomized controlled trial explores if saliva insulin is responsive to the kinds of obesity and caries intervention currently in progress in schools, namely drinking water intervention.
The specific aims of this randomized controlled trial are to:
Determine if the standard serving (500 ml) of drinking water normalizes saliva insulin to a greater extent, within 60 min, than no beverage or a standard serving (200 ml) apple juice in elementary school age children.
Determine if, in line with lower saliva insulin, 500 ml drinking water significantly alters macronutrient metabolism, within 60 min, relative to no beverage or 200 ml apple juice.
Determine if 500 ml drinking water reduces caries risk factors, improves saliva osmolality, pH, buffering capacity and immune response to a greater extent, within 60 min, than no beverage or 200 ml apple juice.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- Model description
- Three randomly assigned groups, with randomization stratified by weight status, with measurements at baseline and post-intervention
| Arm | Type | Receives |
|---|---|---|
| No drink | No intervention | –Control; Participants will receive no drink |
| Drinking water | Experimental | Other: Drinking waterIntervention drink; Participants will receive 500 ml drinking water from the San Francisco tap (i.e. fluoridated tap water). 500 ml is the standard bottle size. |
| Apple juice | Active comparator | Other: Apple juiceIntervention drink; Participants will receive 200 ml box of apple juice. 200 ml is the standard serving usually available to this study population in the school setting |
Who may qualify
- Ages
- 5 to 10 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (1 listed)
- UCSF Pediatric Dental Clinic patients New patient exam or recall exams Caregiver and child speak English, Spanish or Chinese Ages 5-10 years San Francisco residents Non-acutely ill (healthy enough to attend school, no fever and no systemic conditions)
Key exclusion criteria (1 listed)
- Child and caregiver do not speak English, Spanish or Chinese Not a San Francisco resident Under age 5 years Over age 10 years Child unwilling to accept randomized drink assignment Child unable or unwilling to drink water or apple juice Child unable or unwilling to give saliva Child is presenting to the dental clinic for an operative procedure Acute illness, fever, infection or condition that would prevent the child from attending school No remaining space in study group (weight-specific recruitment is complete).
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 |
|---|---|---|
| Drinking waterThe intervention will compare the effects of a usual serving of drinking water with the effects of a usual serving of apple juice. Both beverages will also be assessed relative to the effects of not drinking anything at all. | Other | Drinking water |
| Apple juiceapple juice | Other | Apple juice |
Primary outcome
Lower saliva insulin after drinking water compared to juice; compared to no drink
Time frame: 1 hour
Lower mean saliva insulin; Greater relative odds of saliva insulin below 5mU/I
4 secondary outcomes
Different untargeted metabolomic profile after drinking water compared to juice; and after drinking water compared to no drink
Time frame: 1 hour
Higher saliva pH (potential of hydrogen) after drinking water than after apple juice or no drink
Time frame: 1 hour
Higher saliva buffering capacity after drinking water than after apple juice or no drink
Time frame: 1 hour
Significantly higher saliva secretory immunoglobin a (IgA) after drinking water than after apple juice or no drink
Time frame: 1 hour
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 25 Feb 2026.
- 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.
Jodi Stookey, PhD principal investigator
San Francisco Department of Public Health
Thomas Tanbonliong, DDS principal investigator
University of California, San Francisco
Mimansa Cholera, DDS principal investigator
University of California, San Francisco
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Drinking water and Apple juice in people with Caries and Metabolomic Profile, run by Jodi Stookey at 1 site in United States.
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 1 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 25 Feb 2026. 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 United States. 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. 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?
Lower saliva insulin after drinking water compared to juice; compared to no drink (time frame: 1 hour). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Feb 2026; AzTrials last refreshed its copy on 8 Nov 2026.