Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries

NCT05211843 | Completed

• 1 other identifier: Saliva insulin biomarker
• Study Type: interventional
• Target: 105
• Locations: 1 country
• Sites: 1

Brief 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 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.

Conditions

Caries; Metabolomic Profile

Outcome Measures

Primary Outcomes (1)

• 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

  1 hour

Secondary Outcomes (4)

• Different untargeted metabolomic profile after drinking water compared to juice; and after drinking water compared to no drink

  1 hour

• Higher saliva pH (potential of hydrogen) after drinking water than after apple juice or no drink

  1 hour

• Higher saliva buffering capacity after drinking water than after apple juice or no drink

  1 hour

• Significantly higher saliva secretory immunoglobin a (IgA) after drinking water than after apple juice or no drink

  1 hour

Study Arms (3)

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.

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

Other: Apple juice

Interventions

Drinking water OTHER

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.

Drinking water

Apple juice OTHER

apple juice

Apple juice

Eligibility Criteria

• Age: 5 Years - 10 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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)

You may not qualify if:

• 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).

Sponsors & Collaborators

• Jodi Stookey: lead

Study Sites (1)

UCSF Pediatric Dentistry

San Francisco, California, 94143, United States

Location

MeSH Terms

Interventions

Drinking Water

Intervention Hierarchy (Ancestors)

Water; Hydroxides; Alkalies; Inorganic Chemicals; Anions; Ions; Electrolytes; Oxides; Oxygen Compounds; Beverages; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• Jodi Stookey, PhD

  San Francisco Department of Public Health

  PRINCIPAL INVESTIGATOR

• Thomas Tanbonliong, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

• Mimansa Cholera, DDS

  University of California, San Francisco

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The participant will know what group they are assigned to as they will see and taste the assigned beverage. The investigator who assigns participants to a treatment group will not administer the beverage or collect data. The investigator who administers the beverage will know the group assignment. The laboratory staff who assess the outcomes will not know the assignment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: MCAH Senior Epidemiologist

Model Details: Three randomly assigned groups, with randomization stratified by weight status, with measurements at baseline and post-intervention

Study Record Dates

• First Submitted: December 17, 2021
• First Posted: January 27, 2022
• Study Start: October 12, 2022
• Primary Completion: December 31, 2023
• Study Completion: January 29, 2024
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)