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

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Pediatric Obesity; Puberty, Precocious
• Intervention / Treatment: Dietary supplement: Decaffeinated Green Tea Polyphenol; Other: Placebo control

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.

• Study Type: Interventional
• Enrollment (Actual): 80
• Phase: Not Applicable

Contacts and Locations

Study Locations

• China
  • Shanghai
    • Shanghai, Shanghai, China, 200092
      • Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 10 years (CHILD)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: PREVENTION
• Allocation: RANDOMIZED
• Interventional Model: PARALLEL
• Masking: QUADRUPLE

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
EXPERIMENTAL: 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	Dietary supplement: 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.
PLACEBO_COMPARATOR: Control group; 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; 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.

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
• Investigators: Study Chair: Xiuhua Shen, Professor, Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start (ACTUAL): August 28, 2018
• Primary Completion (ACTUAL): January 31, 2020
• Study Completion (ANTICIPATED): July 31, 2023

Study Registration Dates

• First Submitted: July 10, 2018
• First Submitted That Met QC Criteria: August 9, 2018
• First Posted (ACTUAL): August 14, 2018

Study Record Updates

• Last Update Posted (ACTUAL): April 22, 2020
• Last Update Submitted That Met QC Criteria: April 20, 2020
• Last Verified: December 1, 2019

More Information

Terms related to this study

• Keywords: Prevention; Green tea polyphenols; Precocious puberty; Children obesity
• Additional Relevant MeSH Terms: Endocrine System Diseases; Gonadal Disorders; Overnutrition; Nutrition Disorders; Overweight; Body Weight; Obesity; Pediatric Obesity; Puberty, Precocious
• Other Study ID Numbers: XH-18-009

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No