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
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 105
- 试验地点
- 1
- 主要终点
- Lower saliva insulin after drinking water compared to juice; compared to no drink
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Prevention
- 盲法
- Single (Outcomes Assessor)
盲法说明
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.
入排标准
- 年龄范围
- 5 Years 至 10 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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)
排除标准
- •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).
研究组 & 干预措施
No drink
Control; Participants will receive no drink
Drinking water
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.
干预措施: Drinking water (Other)
Apple juice
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
干预措施: Apple juice (Other)
结局指标
主要结局
Lower saliva insulin after drinking water compared to juice; compared to no drink
时间窗: 1 hour
Lower mean saliva insulin; Greater relative odds of saliva insulin below 5mU/I
次要结局
- Higher saliva pH (potential of hydrogen) 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)
- Different untargeted metabolomic profile after drinking water compared to juice; and after drinking water compared to no drink(1 hour)
- Higher saliva buffering capacity after drinking water than after apple juice or no drink(1 hour)
研究者
Jodi Stookey
MCAH Senior Epidemiologist
San Francisco Department of Public Health