Pediatric ObesityNCT03628937
The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
A study testing Decaffeinated Green Tea Polyphenol in people with Pediatric Obesity and Puberty, Precocious, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 6 to 10 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Pediatric Obesity, Puberty, Precocious
- What is being tested?
- Decaffeinated Green Tea Polyphenol
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- 28 Aug 2018to 31 Jul 2023
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 6 to 10 years
- Women only
- Healthy volunteers accepted
- Child
Who may be able to join
- 6-10 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;
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Clinical Nutrition, Xinhua Hospital Affiliated to Shanghai Jiao Tong University School of Medicine
Shanghai, Shanghai Municipality, 200092
About this study
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.
Read the 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.
- Conditions
- Pediatric Obesity, Puberty, Precocious
- Being tested
- Decaffeinated Green Tea Polyphenol, Placebo control
- Keywords
- Green tea polyphenols, Children obesity, Precocious puberty, Prevention
- Medical subject headings
- Pediatric Obesity, Puberty, Precocious
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Decaffeinated Green Tea PolyphenolDietary 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.
Placebo controlOther
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.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Placebo control |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: about two years
Secondary outcomes (7)
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.
Measured: 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.
Measured: 12 weeks
The change of breast tissue volume at week 12 intervention from the baseline
These indicator is important indicators related to sexual development.
Measured: 12 weeks
The change of uterus volume at week 12 intervention from the baseline
These indicator is important indicators related to sexual development.
Measured: 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.
Measured: 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.
Measured: 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
Measured: 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Aug 2018
- Study start28 Aug 2018
- Primary completion31 Jan 2020
- Study completion31 Jul 2023 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Pediatric ObesityStudies of the same condition, open and under way.
- More trials run by Xinhua Hospital, Shanghai Jiao Tong University School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xiuhua Shen, Professor, Study chair, Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03628937
- Sponsor's protocol ID
- XH-18-009
- Status last verified
- Dec 2019
- First submitted
- 10 Jul 2018
- Last updated
- 22 Apr 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
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.
PubMed 34712203
Study at a glance
From the registry record, last updated by the sponsor on 22 Apr 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Decaffeinated Green Tea Polyphenol Intake on the Risk of Precocious Puberty Among Obese Girls
- ClinicalTrials.gov ID
- NCT03628937
- Acronym / sponsor ID
- XH-18-009
- Conditions
- Pediatric Obesity, Puberty, Precocious
- Keywords
- Green tea polyphenols, Children obesity, Precocious puberty, Prevention
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Xinhua Hospital, Shanghai Jiao Tong University School of MedicineUniversity, hospital or other
- Study start
- 28 Aug 2018 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jul 2023 (estimated)
- First posted
- 14 Aug 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention group | Experimental | Dietary Supplement: Decaffeinated Green Tea PolyphenolInterventions: 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 |
| Control group | Placebo comparator | Other: Placebo controlThe placebo control group will be given placebo capsules, and participants need take it once a day after breakfast for 12 weeks. |
Who may qualify
- Ages
- 6 to 10 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (4 listed)
- 6-10 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;
Key exclusion criteria (7 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Decaffeinated Green Tea PolyphenolIntervention 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. | Dietary supplement | Intervention group |
| Placebo controlThe 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. | Other | Control group |
Primary outcome
The incidence of Precoicous Puberty in the intervention groups and the placebo group.
Time frame: about two years
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.
7 secondary outcomes
The average age of onset of menarche in two groups
Time frame: an average of 4 years
The change in BMI at week 12 intervention from the baseline
Time frame: 12 weeks
The change of breast tissue volume at week 12 intervention from the baseline
Time frame: 12 weeks
The change of uterus volume at week 12 intervention from the baseline
Time frame: 12 weeks
The change of the number of follicles with diameter of > 4mm follicles in ovary at week 12 intervention from the baseline
Time frame: 12 weeks
The change of serum sex hormone levels at week 12 intervention from the baseline
Time frame: 12 weeks
The status of liver and kidney function at the baseline and after 12 weeks intervention
Time frame: 12 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Apr 2020.
- Derived from this study: PubMed 34712203Xie 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Xiuhua Shen, Professor study chair
Xinhua Hospital Afflicated to Shanghai Jiaotong University of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Decaffeinated Green Tea Polyphenol in people with Pediatric Obesity and Puberty, Precocious, run by Xinhua Hospital, Shanghai Jiao Tong University School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Apr 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The incidence of Precoicous Puberty in the intervention groups and the placebo group. (time frame: about two years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03628937, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Apr 2020.