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临床试验/NCT06500104
NCT06500104Enrolling By Invitation不适用

The Effects of Kefir on Pediatric Obesity

China Medical University Hospital2 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2024年7月6日最近更新:
适应症

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
60
试验地点
2
主要终点
BMI

研究概览

简要总结

Kefir, a traditional fermented dairy product in the North Caucasus region, is produced through the fermentation of milk by lactic acid bacteria and yeast. In murine studies, it has been observed that consumption of kefir by obese mice resulted in significantly reduced body weight compared to non-kefir-consuming obese mice. Furthermore, insulin resistance and fatty liver conditions showed improvement in the kefir-fed obese mice. Kefir was found to have its effects on obesity-related conditions through the inhibition of lipid synthesis, stimulation of fatty acid oxidation, elevation of basal metabolic rate, and modulation of oxidative damage.

Obesity has emerged as a global epidemic, and its prevalence in pediatric population is rapidly increasing. Obesity is defined as having a body mass index (BMI) above the 95th percentile for the age. According to statistics from the Health Promotion Administration in Taiwan, the prevalence of obesity among elementary and junior high school students in 2021 was 27.1% and 31.2%, respectively. This implies that approximately one out of every three to four students is obese. Insulin resistance and fatty liver are two common manifestations of childhood obesity. Insulin resistance is found closely linked to type 2 diabetes. Prolonged and chronic fatty liver can progress to cirrhosis and even hepatocellular carcinoma. Effective management of obesity holds the occurrence of these diseases. The objective of this study is to analyze the potential benefits of incorporating kefir into the diet of obese children regarding the improvement of obesity-related outcomes.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
7 Years 至 17 Years(Child)
性别
All
接受健康志愿者

入选标准

  • body weight above 40 kilograms, body mass index (BMI)-for-age above the 95th percentile

排除标准

  • diabetes mellitus, liver diseases other than non-alcoholic fatty liver disease, cardiovascular diseases other than hypertension and dyslipidemia, renal diseases, neurologic diseases, growth hormone deficiency, thyroid diseases, adrenal disorders, any use of medication for more than 6 months before or during this study, and any adverse responses to dairy products.

结局指标

主要结局

BMI

时间窗: From enrollment to the end of treatment at 12 weeks

BMI

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

研究点 (2)

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