The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
试验速览
- 阶段
- 不适用
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- The incidence of Precoicous Puberty in the intervention groups and the placebo group.
研究概览
简要总结
In this study, 6-10 years old obese girls will be recruited to test the preventive effect of decaffeinated green tea polyphenols on the risk of precocious puberty by the random, placebo-control and single blind design. The intervention group will be given decaffeinated green tea polyphenols capsule (400mg/d) and the control group will be given placebo. The oral treatment will be lasted for 12 weeks.Then all the subjects will be followed up every 3 months until three months after menstruation. At the baseline and after the 12 week intervention, the clinical manifestations of secondary sexual characters, the serum levels of sex hormones will be determined as the outcome variables. After controlling confounding factors, the preventive effect of the green tea polyphenols on precocious puberty or early puberty among obese girls will be analyzed.
详细描述
Simple obese girls are prone to premature or early puberty. The topic proposed based on previous studies, recruiting of 80 simple overweight or obesity girls, aged 6 to 10 years old. After the informed consent, they will be randomly divided into intervention group and control group, intervention group will be given tea polyphenol capsule (400 mg, epigallocatechin gallate (EGCG) accounted for 50%), the control group given placebo capsule. Participants need take it once a day after breakfast. All of them will receive similar health advice on proper diet and exercise. The intervention will last 12 weeks, followed by telephone every 3 months until 3 months after menarche. The researchers will measure children obesity index (using artificial detection), youth development index (secondary sex characteristic clinical manifestations, serum sex hormone, B ultrasonic examination uterus ovarian and breast volume, etc.) in three stages: at the baseline, after 12 weeks intervention and the end of three months after menstruation. The liver and kidney function, blood and urine routine and serum trace elements will be detected before and after the three-month intervention. Through the above detection of the indicators related to obesity and sexual precocious puberty, it is explored whether the decaffeinated tea polyphenol has preventive effects on precocious puberty.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 6 Years 至 10 Years（Child）
- 性别
- Female
- 接受健康志愿者
- 是
入选标准
- •6-10 years old;
- •BMI reached or exceeded the overweight or obesity threshold of school-aged girls in China (6 years old, BMI>=16.3; 7 years old, BMI>=17.2; 8 years old, BMI>=18.1;9 years old, BMI>=19.0; Age of 10, BMI>=20.0);
- •having not received sex hormone drugs, gonadotropin-releasing hormone (GnRH) drugs and Chinese medicine for the prevention and treatment of precocious puberty in the past;
- •the guardian's informed consent;
排除标准
- •secondary obesity (such as hormone therapy);
- •weight loss treatment is currently under way;
- •menarche or central precocious puberty has been clearly diagnosed;
- •patients with serious heart, liver, kidney, hematopoietic system diseases and endocrine genetic metabolic diseases;
- •iron therapy is under way;
- •patients with acute and chronic inflammation;
- •other conditions that the researchers believe may influence the observation results.
结局指标
主要结局
The incidence of Precoicous Puberty in the intervention groups and the placebo group.
时间窗: about two years
Female precocious puberty is defined as the development of secondary sexual characteristics before the age of 8 or menarche before the age of 10. In our study, after intervention, for girls under 8 years of age, we recorded their rate of secondary sexual characteristics at 8 years of age; and for girls under 10 years of age, we recorded their rate of menarche at 10 years of age. The difference in the incidence of precocious puberty between the two groups is the primary outcome.
次要结局
- The change in BMI at week 12 intervention from the baseline(12 weeks)
- The change of serum sex hormone levels at week 12 intervention from the baseline(12 weeks)
- The change of breast tissue volume at week 12 intervention from the baseline(12 weeks)
- The average age of onset of menarche in two groups(an average of 4 years)
- The change of uterus volume at week 12 intervention from the baseline(12 weeks)
- The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline(12 weeks)
- The status of liver and kidney function at the baseline and after 12 weeks intervention(12 weeks)