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

NCT03628937 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 80

Last updated 2020-04-22

No results posted yet for this study

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.

Conditions

  • Pediatric Obesity
  • Puberty, Precocious

Interventions

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.

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.

Sponsors & Collaborators

  • Xinhua Hospital, Shanghai Jiao Tong University School of Medicine

    lead OTHER

Principal Investigators

  • Xiuhua Shen, Professor · Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
6 Years
Max Age
10 Years
Sex
FEMALE
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-08-28
Primary Completion
2020-01-31
Completion
2023-07-31

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03628937 on ClinicalTrials.gov