Clinical Trials Logo

Clinical Trial 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.


Clinical Trial 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 Design


Related Conditions & MeSH terms


NCT number NCT03628937
Study type Interventional
Source Xinhua Hospital, Shanghai Jiao Tong University School of Medicine
Contact
Status Active, not recruiting
Phase N/A
Start date August 28, 2018
Completion date July 31, 2023

See also
  Status Clinical Trial Phase
Not yet recruiting NCT03994419 - PErioperAtive CHildhood ObesitY
Recruiting NCT06111040 - Nurturing Needs Study: Parenting Food Motivated Children N/A
Completed NCT03036696 - The BEACH Interview Study- Pregnant and Breastfeeding Mothers
Not yet recruiting NCT02484612 - Exercise Intensity and Appetite in Adolescents N/A
Completed NCT02959034 - Pediatric Metabolism and Microbiome Repository
Completed NCT02545764 - Training Induced Reduction of Lower-limb Joint Loads During Locomotion in Obese Children N/A
Recruiting NCT02426346 - A Scalable Weight Control Intervention for Adolescents Phase 2
Completed NCT01989065 - Healthy Lifestyles Program for You (HLP4U): Augmenting Childhood Obesity Treatment. N/A
Completed NCT02160847 - Development of the DRIVE Curriculum to Address Childhood Obesity Risk Factors N/A
Completed NCT01908153 - Taste Reward Processing in Pediatric Obesity
Completed NCT02343588 - A National School-based Health Lifestyles Interventions Among Chinese Children and Adolescents Against Obesity N/A
Completed NCT02375490 - Healthy Start to Increase Physical Activity and Improve Healthy Eating in Early Childcare Centres N/A
Completed NCT02074332 - Study on Obesity Intervention With Physical Exercise Among Students in Changping District, Beijing N/A
Completed NCT02086851 - Study of a Structured Parent Intervention on Adolescent Weight Loss Modification Program. N/A
Completed NCT01146314 - A Family Based Intervention to Reduce the Risk of Type 2 Diabetes in Children N/A
Terminated NCT00846521 - Study of Post-meal Blood Sugar Peaks in Association With Vascular Disease in Childhood Obesity Phase 4
Completed NCT04164277 - FirstStep2Health Intervention N/A
Withdrawn NCT04600648 - Sweet Taste Responsiveness in Relation to Insulin, Leptin and Adiposity Among Obese Treatment Seeking Children N/A
Completed NCT04395430 - A Novel School-clinic-community Online Model of Child Obesity Treatment in Singapore During COVID-19 N/A
Completed NCT03139877 - Pediatric Obesity Observational Prospective Trial