The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls

Conditions
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Pediatric Obesity, Puberty, Precocious

Intervention / Treatment
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* Dietary Supplement: Decaffeinated Green Tea Polyphenol
* Other: Placebo control


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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; Exclusion Criteria: 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.

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 10 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intervention group<br>Interventions: Decaffeinated green tea polyphenol capsule (400 mg, EGCG accounted for 50%) will be given to participants in intervention group, and they need take it once a day after breakfast for 12 weeks. Decaffeinated green tea polyphenol: 400mg/capsule, 1 capsule/d, qd, 12 weeks | Dietary Supplement: Decaffeinated Green Tea Polyphenol<br>* Intervention group will be given decaffeinated green tea polyphenol capsules (400 mg, EGCG accounted for 50%). Participants need take it once a day after breakfast for 12 weeks.<br>|
| Placebo Comparator: Control group<br>The placebo control group will be given placebo capsules, and participants need take it once a day after breakfast for 12 weeks. | Other: Placebo control<br>* The starch capsule was used as a placebo control, which has the same dosage, appearance and smell compared to decaffeinated green tea polyphenol capsule. The use frequency and duration are consistent with intervention group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The incidence of Precoicous Puberty in the intervention groups and the placebo group. | 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. | about two years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The average age of onset of menarche in two groups | Record the age of the onset of menarche of each girl and comparing the average age between two groups, to explore whether green tea polyphenols could delay the early pubertal development. | an average of 4 years | 
| The change in BMI at week 12 intervention from the baseline | Obesity is an important contributing factor to the early onset of puberty for girls. Green tea polyphenols may prevent precocious puberty by controlling body weight and reducing serum leptin level. | 12 weeks | 
| The change of breast tissue volume at week 12 intervention from the baseline | These indicator is important indicators related to sexual development. | 12 weeks | 
| The change of uterus volume at week 12 intervention from the baseline | These indicator is important indicators related to sexual development. | 12 weeks | 
| The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline | These indicator is important indicators related to sexual development. | 12 weeks | 
| The change of serum sex hormone levels at week 12 intervention from the baseline | These indicators are important indicators related to sexual development. | 12 weeks | 
| The status of liver and kidney function at the baseline and after 12 weeks intervention | To identify the safety of green tea polyphenol intake for obese girls | 12 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Green tea polyphenols, Children obesity, Precocious puberty, Prevention