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

NCT03628937 | Unknown

• 1 other identifier: XH-18-009
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Green tea polyphenols; Children obesity; Precocious puberty; Prevention

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (7)

• The average age of onset of menarche in two groups

  an average of 4 years

• The change in BMI at week 12 intervention from the baseline

  12 weeks

• The change of breast tissue volume at week 12 intervention from the baseline

  12 weeks

• The change of uterus volume at week 12 intervention from the baseline

  12 weeks

• The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline

  12 weeks

Study Arms (2)

Intervention group

EXPERIMENTAL

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

Control group

PLACEBO COMPARATOR

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

Interventions

Decaffeinated Green Tea Polyphenol 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.

Intervention group

Placebo control 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.

Control group

Eligibility Criteria

• Age: 6 Years - 10 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• years old;
• 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);
• 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;
• the guardian's informed consent;

You may not qualify if:

• secondary obesity (such as hormone therapy);
• weight loss treatment is currently under way;
• menarche or central precocious puberty has been clearly diagnosed;
• patients with serious heart, liver, kidney, hematopoietic system diseases and endocrine genetic metabolic diseases;
• iron therapy is under way;
• patients with acute and chronic inflammation;
• other conditions that the researchers believe may influence the observation results.

Sponsors & Collaborators

• Xinhua Hospital, Shanghai Jiao Tong University School of Medicine: lead

Study Sites (1)

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

Shanghai, Shanghai Municipality, 200092, China

Location

Related Publications (1)

• 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.

  PMID: 34712203 DERIVED

MeSH Terms

Conditions

Pediatric Obesity; Puberty, Precocious

Condition Hierarchy (Ancestors)

Obesity; Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Gonadal Disorders; Endocrine System Diseases

Study Officials

• Xiuhua Shen, Professor

  Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 10, 2018
• First Posted: August 14, 2018
• Study Start: August 28, 2018
• Primary Completion: January 31, 2020
• Study Completion: July 31, 2023
• Last Updated: April 22, 2020

Record last verified: 2019-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)