Pediatric Obesity Clinical Trial
Official title:
The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
Verified date | December 2019 |
Source | Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Active, not recruiting |
Enrollment | 80 |
Est. completion date | July 31, 2023 |
Est. primary completion date | January 31, 2020 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | Female |
Age group | 6 Years to 10 Years |
Eligibility |
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. |
Country | Name | City | State |
---|---|---|---|
China | Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine | Shanghai | Shanghai |
Lead Sponsor | Collaborator |
---|---|
Xinhua Hospital, Shanghai Jiao Tong University School of Medicine |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | 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 | 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 | |
Secondary | 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 | |
Secondary | The change of breast tissue volume at week 12 intervention from the baseline | These indicator is important indicators related to sexual development. | 12 weeks | |
Secondary | The change of uterus volume at week 12 intervention from the baseline | These indicator is important indicators related to sexual development. | 12 weeks | |
Secondary | 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 | |
Secondary | 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 | |
Secondary | 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 |
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