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

NCT05211843 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 105

Last updated 2026-02-25

No results posted yet for this study

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

Interventions

OTHER

Drinking water

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.

OTHER

Apple juice

apple juice

Sponsors & Collaborators

  • Jodi Stookey

    lead OTHER_GOV

Principal Investigators

  • Jodi Stookey, PhD · San Francisco Department of Public Health

  • Thomas Tanbonliong, DDS · University of California, San Francisco

  • Mimansa Cholera, DDS · University of California, San Francisco

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
5 Years
Max Age
10 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-10-12
Primary Completion
2023-12-31
Completion
2024-01-29

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05211843 on ClinicalTrials.gov