The Sweet Kids Study (Stevia on Weight and Energy Effect Over Time)
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- Body mass index (BMI) z-scores
研究概览
简要总结
This is an 8 to14-week three-arm randomized controlled in children 8 to 12 years old.
The main purpose of the study is to evaluate if stevia has benefits for weight control and metabolic function relative to caloric sweeteners, and whether it provides benefits in this regard similar to water.
详细描述
Up to 150 children will be enrolled in the study to achieve a final sample of 90 completers (30 per group). The proposed study will be an 8 to 14-week, three-arm, randomized, controlled, blinded trial in children ages 8 to 12 years from the Central Arkansas region. Children will be randomized to consume one of three beverages: 1) sucrose-sweetened beverage, 2) stevia-sweetened beverage, or 3) calorie-free flavored water beverage. Participants with excessive weight (BMI percentile ≥85th and <140 percent of the 95th percentile) will complete a 14-week intervention whereas normal-weight (BMI percentile <85th) participants will complete an 8-week intervention in parallel.
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 8 Years 至 12 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- 未提供
排除标准
- 未提供
结局指标
主要结局
Body mass index (BMI) z-scores
时间窗: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
The change in BMI z-score will be calculated: BMI z-score at completion of the study minus BMI z-score at baseline
Fat mass index z-scores
时间窗: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
The change in fat mass index (FMI) z-score will be calculated: FMI z-score at completion of the study minus FMI z-score at baseline.
Homeostatic Model Assessment for Insulin Resistance (HOMA-IR)
时间窗: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
HOMA-IR is a unitless estimate of insulin resistance, and it is calculated from fasting glucose and insulin
Fasting plasma lipids (Total cholesterol, HDL-cholesterol, triglycerides, LDL-cholesterol)
时间窗: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Fasting plasma lipids, mg/dl
Blood pressure percentiles
时间窗: Measurements will be obtained at enrollment (baseline) and again at weeks 4 and 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.
Systolic and diastolic blood pressure percentiles calculated using reference standards from the American Academy of Pediatrics.
次要结局
- Gut microbial communities(Measurements will be obtained at enrollment (baseline) and again at week 8 for all participants. Children with excessive weight will also complete an additional assessment at week 14.)