Plants Optimizing Development Study
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- Sex steroid excretion
研究概览
简要总结
This study aims to conduct a randomized clinical trial to measure the effects of a 3-month daily mixed-soy food intervention vs. a control group receiving isocaloric foods on reproductive hormones, body composition, metabolic risk, fecal microbiota, and cognition among 8-11-year-old children. Additionally, this study will assess soy food intake immediately following participation in the clinical trial to determine changes in soy food acceptance in children.
详细描述
The central hypothesis is that greater soy isoflavone consumption does not alter sex steroid levels but is associated with beneficial clinical outcomes of body composition, metabolic health, and gut-brain axis among pre- and early adolescents.
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
- None
入排标准
- 年龄范围
- 8 Years 至 11 Years（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Child assent and parent/guardian consent
- •Free of any food allergy
- •8-11 years of age
- •Tanner scale score of ≤ 2
- •20/20 or corrected vision
- •No antibiotic usage in the past 3 months
- •≤1 serving/d of soy food habitual consumption
排除标准
- •Non-assent or consent by child assent and/or parent/guardian
- •Presence of any food allergy
- •Younger than 8 years or older than 11 years
- •Presence of specific neurological and genetic disorders (i.e., Autism, Cerebral Palsy, Multiple Sclerosis, Down syndrome)
- •Presence of endocrine, metabolic, and gastrointestinal disease e.g., hypertension, diabetes, celiac disease
- •Tanner scale score of > 2
- •Not 20/20 or uncorrected vision
- •Antibiotic usage in the past 3 months
- •>1 serving/d of soy food habitual consumption
结局指标
主要结局
Sex steroid excretion
时间窗: 3 months (Baseline vs Follow-up)
urinary concentration of androgen and estrogenic steroids
次要结局
- Hippocampal-dependent Relational memory(3 months (Baseline vs Follow-up))
- Pubertal Staging(3 months (Baseline vs Follow-up))
- Attentional Reaction Time(3 months (Baseline vs Follow-up)
- Cognitive Abilities and Academic Achievement(3 months (Baseline vs Follow-up))
- Gut microbiota(3 months (Baseline vs Follow-up))
- Body Composition(3 months (Baseline vs Follow-up))
- Metabolic Markers(3 months (Baseline vs Follow-up))
- Attentional Accuracy(3 months (Baseline vs Follow-up))