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

Shanghai Jiao Tong University

Status: Unknown

Conditions: Puberty, Precocious; Pediatric Obesity

Treatments: Other: Placebo control; Dietary Supplement: Decaffeinated Green Tea Polyphenol

Study type: Interventional

Funder types: Other

Identifiers

NCT03628937

XH-18-009

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 patients

Sex: Female

Ages: 6 to 10 years old

Volunteers: Accepts Healthy Volunteers

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.

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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80 participants in 2 patient groups, including a placebo group

Intervention group

Experimental group

Description:

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

Treatment:

Dietary Supplement: Decaffeinated Green Tea Polyphenol

Control group

Placebo Comparator group

Description:

The placebo control group will be given placebo capsules, and participants need take it once a day after breakfast for 12 weeks.

Treatment:

Other: Placebo control