| BACKGROUND There is an increasing number of children suffering from early sexual development and precocious puberty,especially in girls,which not only affect their physical and mental health,but also have influence on their health in adulthood.Obesity has close correlation with early sexual development,especially for girls.Leptin is a peptide hormone secreted by adipocytes in proportion of the amount of energy stored in fat and a key factor of the onset of puberty,which is the critical link between obesity and precocious puberty.Green tea polyphenols(GTP),as the main functional component of tea,have been found to have preventive and therapeutic effects against obesity and pertinent chronic diseases in some studies,and there are also evidences that they work in the decreasing of leptin level of obese animals and humans.Evidences mentioned above supported that the GTP can reduce leptin level,and the leptin level is possibly permissive for initiating puberty.We hypothesized that GTP may prevent precocious puberty.Currently,human studies on GTP mainly focus on adults,while few studies on children,possibly due to adverse effects of caffeine on children’s sleep and mental activities.Some experts believe that regardless of the effects of caffeine,drinking tea is a healthy behavior for children.Thus,our study used decaffeinated green tea polyphenols(DGTP)on obese girls,to confirm the effect of DGTP on postponing initiating puberty on obesity girls.We hope to explore new ways for safe and effective prevention and treatment of obese girls’ precocious puberty.OBJECTIVES1.To explore the effect of DGTP on the amelioration of the weight of obese girls.2.To explore the effect of DGTP on the prophylaxis and amelioration of early sexual development and precocious puberty in obese girls.3.To examine the safety of DGTP use in obese girls to prevent precocious puberty.METHODS This clinical study was a randomized,placebo-controlled trial.Overweight and obese girls aged 6 to 10 years old were recruited and randomly assigned to two groups: an intervention group and a control group during July 2018 to December 2019.The intervention group was given 400mg/d DGTP soft capsules(200mg/ capsule,polyphenol epigallocatechin-3-gallate(EGCG)accounted for 50%,two capsules a day).As for the placebo group,the soybean oil soft capsules were used as placebo control,which were presented the same dosage,appearance and smell compared to DGTE capsules.Participants need take two capsules once a day after dinner,lasted12 weeks.During this period,all participants received almost consistent guidance on diet and exercise from the professional doctors or dietitians,and were asked for keeping consistency as much as possible.Demographic and lifestyle questionnaire were used to collect the baseline information before the intervention.The obesity-related indicators,puberty-related indicators and safety indexes both before and after the 12-week intervention were collected through physical examination,bioelectrical impedance analysis,B-scan ultrasonography of uterus,ovary and breast,bone-age detection and biochemical-indicator detection(including sex hormone,trace element,liver function test and renal function test,inflammatory factors,key factors of the onset of puberty and blood routine examination etc.).Food frequency questionnaire(FFQ)and 24-hour diet recall were used to collect their nutrients intake before and during the 12-week intervention time.Independent t-tests and chi-square tests were performed to examine the differences in obesity-related indicators,puberty-related indicators and safety Indexes between tea polyphenol group and placebo group both before and after the 12-week intervention.Paired t-tests and paired chisquare tests were conducted within-group analysis in both two groups before and after the intervention,analyzing the change in obesity-related indicators,puberty-related indicators and safety indexes.And multiple linear regression and logistic regressive model were used to evaluate the influence of taking tea polyphenols or placebos on the indicators above.RESULTS Till January 2020,a total of 62 obese girls had completed the 12-week intervention.We included the data of this group before and after the intervention into the study analysis:1.In terms of the indicators in obesity,after 12-week intervention,both tea polyphenol group and placebo group had a significant increase in height and basic metabolic rate.BMI,waist circumference,WHR and WHt R decreased significantly over time.DGTP group had significant increase in fat free weight and decrease in body fat percentage,while there was no significant difference in the changes of these two indicators in placebo group.When it comes to biochemical indicators,the number of people having abnormal values in serum inflammatory factor IL-6 or tumor necrosis factor TNF-α decreased in tea polyphenol group,who also had a significantly decrease in blood uric acid level,while there was no statistical difference in the placebo group.After controlling confounding factors,like age,parental occupation,family income,exercise,dietary intake of nutrients,the change of body fat percentage in tea polyphenol group after12-week intervention decreased by 2.932% [β=2.932,95%CI:(0.214,5.650),p=0.035] compared with placebo group,and there was also a decrease of 13.295 pg/ml [β=13.295,95%CI:(5.539,21.052),p=0.006] in the change of average serum inflammatory factor IL-6 level and a decrease of 52.601 μmol/L [β=52.601,95%CI:(2.520,102.681),p=0.040] in the change of average blood uric acid level compared with placebo group.Furthermore,the effect of DGTP on the participants after 12-week intervention on ?IL-6 was the greatest,while that on ?UA was next,and that on ?PBF came in last.2.In terms of the indicators in sexual development,the number of girls in Tanner stage II of breast increased in both groups after 12-week intervention,and uterine volume also increased significantly.Volume of both two ovaries in DGTP group decreased significantly,and the number of girls with follicles>4mm decreased either.Placebo group had an increase in both left and right ovarian volume.However,no significant difference was found.The indexes of sex hormone in both groups changed after 12-week intervention,but no significant difference was found between the two groups.After controlling age,parental occupation,family income,exercise,dietary intakes of nutrients and other confounding factors,the change of average right ovarian volume in tea polyphenol group after12-week intervention decreased by 1880.5 mm3 [β=1880.505,95%CI:(61.861,3699.149),p=0.044] compared with placebo group,and the change of average left ovarian volume in tea polyphenol group decreased by 971.0 mm^3 [β=971.027,95%CI:(19.028,1923.027),p=0.046]compared with placebo group,while there was still no statistical difference in these changes.3.Security assessment: Neither adverse events nor withdrawal of subjects was reported during the whole research.No statistical difference was found in the changes of serum trace elements levels and blood routine indexes between two groups or among their own comparison.Some participants reported that the size of capsule was a little too large,which is difficult to swallow.CONCLUSIONS Our findings show that the decaffeinated green tea polyphenol can improve the indicators both in obesity and in sexual development of obese girls in safety without any adverse events. |
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