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

Caries Clinical Trial

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

Status Recruiting

Clinical 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 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.

Clinical Trial 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. ;

Related Conditions & MeSH terms

• Caries
• Metabolomic Profile

• NCT number: NCT05211843
• Study type: Interventional
• Source: San Francisco Department of Public Health
• Contact: Jodi Stookey, PhD
• Phone: 415-312-0237
• Email: jodi.stookey@sfdph.org
• Status: Recruiting
• Phase: N/A
• Start date: October 12, 2022
• Completion date: December 2023