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

Recruiting in Palo Alto (17 mi)

Overseen byJodi Stookey, PhD

Age: < 18

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Academic

Recruiting

Sponsor: Jodi Stookey

No Placebo Group

Trial Summary

What is the purpose of this trial?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.

Eligibility Criteria

Inclusion Criteria

Non-acutely ill (healthy enough to attend school, no fever and no systemic conditions)

New patient exam or recall exams

You live in San Francisco.

+3 more

Exclusion Criteria

Not a San Francisco resident

Under age 5 years

Over age 10 years

+7 more

Participant Groups

3Treatment groups

Experimental Treatment

Active Control

Group I: Drinking waterExperimental Treatment1 Intervention

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.

Group II: No drinkActive Control1 Intervention

Control; Participants will receive no drink

Group III: Apple juiceActive Control1 Intervention

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