Clinical trial NCT03628937: The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
Official title: The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Pediatric Obesity
Puberty, Precocious
Keywords: Green tea polyphenols
Children obesity
Precocious puberty
Prevention
Lead sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Sponsor class: OTHER
First posted: 2018-08-14
Enrollment: 80
Sex: FEMALE
Minimum age (years): 6
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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: 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.

Eligibility criteria: Inclusion Criteria:

1. 6-10 years old;
2. 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);
3. 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;
4. the guardian's informed consent;

Exclusion Criteria:

1. secondary obesity (such as hormone therapy);
2. weight loss treatment is currently under way;
3. menarche or central precocious puberty has been clearly diagnosed;
4. patients with serious heart, liver, kidney, hematopoietic system diseases and endocrine genetic metabolic diseases;
5. iron therapy is under way;
6. patients with acute and chronic inflammation;
7. other conditions that the researchers believe may influence the observation results.

Primary outcomes:
measure: The incidence of Precoicous Puberty in the intervention groups and the placebo group.
timeFrame: about two years
Secondary outcomes:
measure: The average age of onset of menarche in two groups
timeFrame: an average of 4 years
measure: The change in BMI at week 12 intervention from the baseline
timeFrame: 12 weeks
measure: The change of breast tissue volume at week 12 intervention from the baseline
timeFrame: 12 weeks
measure: The change of uterus volume at week 12 intervention from the baseline
timeFrame: 12 weeks
measure: The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline
timeFrame: 12 weeks
measure: The change of serum sex hormone levels at week 12 intervention from the baseline
timeFrame: 12 weeks
measure: The status of liver and kidney function at the baseline and after 12 weeks intervention
timeFrame: 12 weeks
Other outcomes:
Locations:
city: Shanghai
country: China
facility: Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
state: Shanghai
Study officials:
affiliation: Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine
name: Xiuhua Shen, Professor
role: STUDY_CHAIR
References:
citation: Xie L, Tang Q, Yao D, Gu Q, Zheng H, Wang X, Yu Z, Shen X. Effect of Decaffeinated Green Tea Polyphenols on Body Fat and Precocious Puberty in Obese Girls: A Randomized Controlled Trial. Front Endocrinol (Lausanne). 2021 Oct 12;12:736724. doi: 10.3389/fendo.2021.736724. eCollection 2021.