Clinical trial NCT05211843: Saliva Insulin as Biomarker of Risk Factors for Metabolic Dysregulation and Caries
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
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Caries
Metabolomic Profile
Lead sponsor: San Francisco Department of Public Health
Sponsor class: OTHER_GOV
First posted: 2022-01-27
Enrollment: 120
Sex: ALL
Minimum age (years): 5
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Three randomly assigned groups, with randomization stratified by weight status, with measurements at baseline and post-intervention
Primary purpose: PREVENTION

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.

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.

Eligibility criteria: Inclusion Criteria:

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)

Exclusion Criteria:

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).

Primary outcomes:
measure: Lower saliva insulin after drinking water compared to juice; compared to no drink
timeFrame: 1 hour
Secondary outcomes:
measure: Different untargeted metabolomic profile after drinking water compared to juice; and after drinking water compared to no drink
timeFrame: 1 hour
measure: Higher saliva pH (potential of hydrogen) after drinking water than after apple juice or no drink
timeFrame: 1 hour
measure: Higher saliva buffering capacity after drinking water than after apple juice or no drink
timeFrame: 1 hour
measure: Significantly higher saliva secretory immunoglobin a (IgA) after drinking water than after apple juice or no drink
timeFrame: 1 hour
Other outcomes:
Locations:
city: San Francisco
country: United States
facility: UCSF Pediatric Dentistry
state: California
Study officials:
affiliation: San Francisco Department of Public Health
name: Jodi Stookey, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Thomas Tanbonliong, DDS
role: PRINCIPAL_INVESTIGATOR
affiliation: University of California, San Francisco
name: Mimansa Cholera, DDS
role: PRINCIPAL_INVESTIGATOR
References: