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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-08-28

Study Completion Date

2023-07-31

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.

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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.

Conditions

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Pediatric Obesity Puberty, Precocious

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Intervention group

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

Group Type EXPERIMENTAL

Decaffeinated Green Tea Polyphenol

Intervention Type DIETARY_SUPPLEMENT

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.

Control group

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

Group Type PLACEBO_COMPARATOR

Placebo control

Intervention Type OTHER

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.

Interventions

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Decaffeinated Green Tea Polyphenol

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.

Intervention Type DIETARY_SUPPLEMENT

Placebo control

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.

Intervention Type OTHER

Eligibility Criteria

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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.

Minimum Eligible Age

6 Years

Maximum Eligible Age

10 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes