Obeisty
Conditions
Interventions
Intervention group:On the basis of lifestyle intervention (including dietary intervention and exercise intervention), gastric fiber tablets (Ruijian) are given orally for 3 months. The specific usage
Control group:Provide lifestyle intervention combined with placebo (same dosage form as Ruijian, slightly different packaging), with an intervention period of 3 months.
Sponsors
the Second Affiliated Hospital of Xi'an Jiaotong University
Eligibility
Sex/Gender
All
Age
10 Years to 18 Years
Inclusion criteria
Inclusion criteria: 1) Age 10-18 years old, gender unlimited; 2) It meets the cut-off value of BMI screening for obesity in school-age children and adolescents aged 6-18 years, and meets the diagnostic criteria for moderate and severe obesity ; 3) Obese children who have not received lifestyle intervention in the past; 4) The children were diagnosed as simple moderate to severe obesity by clinical evaluation; 5) The children and their parents agreed to participate in the study and signed the informed consent.
Exclusion criteria
Exclusion criteria: 1) Overweight and slightly obese children and adolescents; 2) People with active gastrointestinal diseases, severe gastritis and other gastric diseases, absorption disorders, gastrointestinal stenosis, who have received bariatric surgery and may be uncomfortable due to excessive intake; 3) Serious comprehension disorder, mental disease, organic disease; 4) Participating in other studies, or taking drugs that affect metabolism and have weight loss effect in recent 3 months; 5) According to the evaluation of clinicians, there are other reasons that are not suitable to participate in this study 6) Allergic to product ingredients; 7) Abdominal surgery was performed within 6 months before the study; 8) T2DM; Severe hypertension; 9) Secondary pathological obesity.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Proportion of weight loss of more than 5% in the two groups at the 6th/12th week; | — |
Secondary
| Measure | Time frame |
|---|---|
| Luteinizing hormone, follicle stimulating hormone, testosterone, estradiol;gene;Liver ultrasound;Insulin C-peptide Release Test;glycosylated hemoglobin;fasting blood glucose, FBG;total cholesterol, TC;triglyceride, TG;low density lipoprotein, LDL;blood pressure; | — |
Countries
China
Contacts
Public ContactChunyan Yin
the Second Affiliated Hospital of Xi'an Jiaotong University
Outcome results
None listed