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临床试验/NCT04910646
NCT04910646Unknown4 期

The Evaluation of Orange Peel Fermentation on Body Fat Lowering Efficacy in Adults

National Taiwan University Hospital0 个研究点目标入组 124 人开始时间: 2021年6月15日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
入组人数
124
主要终点
To evaluate whether the fermented orange peel enzyme has the effect of reducing fat.

研究概览

简要总结

Overweight and obesity can lead to the occurrence of many chronic diseases. In addition to the body mass value (BMI), the excess body fat can also be used as criteria for assessing obesity. Citrus peels are rich in many substances including limonene, Nobiletin, 3-methoxynobiletin, and flavonoids. They could be used for lowering blood pressure and reducing blood pressure, anti-anxiety and sleep aid and etc. Fermentation technology is used to ferment the peel to increase the content of neutral components in citrus peel. Therefore, I want to evaluate whether the fermented orange peel enzyme has the effect of reducing fat.

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
Double (Participant, Care Provider)

入排标准

年龄范围
20 Years 至 65 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
  • For those with BMI ≥ 24 or fatty liver, men's body fat ≥ 25%, women's body fat ≥ 30%
  • Those who are not pregnant and are willing to cooperate with contraception during the trial period.
  • Those who have no history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine disease, mental disease, alcohol or drug abuse, and other major organic diseases (according to medical history).

排除标准

  • Pregnant women, people with a history of cardiovascular disease, organ transplantation, epilepsy or convulsions, liver and kidney disease, malignant tumors, endocrine diseases, mental illness, alcohol or drug abuse, and other major organic diseases (according to medical history).
  • Those who had undergone major surgery or bariatric surgery (according to medical history).
  • Currently or within 3 months before participating in the screening, those subjects used drugs that can affect body fat or increase weight significantly, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability Drugs (according to medical history) will be excluded.

研究组 & 干预措施

orange peel fermentation

Experimental

干预措施: orange peel fermentation (Drug)

placebo

Placebo Comparator

干预措施: Placebo (Drug)

结局指标

主要结局

To evaluate whether the fermented orange peel enzyme has the effect of reducing fat.

时间窗: 8 weeks

Obesity related markers

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Sponsor

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