The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
试验速览
- 阶段
- 4 期
- 入组人数
- 96
- 主要终点
- To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.
研究概览
简要总结
Obesity is a serious global public health issue. Many reports have showed that the use of appropriate probiotics can bring benefits to the health of the host and promote the balance of gut microbiota. Clinical experimental data show that the supplement of probiotics can help regulate gut function and weight control, and etc.
TCI378 (Lactobacillus plantarum TCI378) is a probiotic extracted from Korean kimchi, and TCI507 (Lactobacillus plantarum TCI507) is a probiotic extracted from the oranges peels. These two strains of probiotics have been verified by in vitro experiments to have the effect of hydrolyzing bile salts, inhibition of the production of fat cells. Therefore, we want to evaluate whether the probiotics TCI308 and TCI507 have effects on reduction of body weight.
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
- 否
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, 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).
研究组 & 干预措施
Placebo
Placebo without TCI378 and TCI507
干预措施: Placebo (Drug)
TCI378
probiotics TCI378 (Lactobacillus plantarum TCI378)
干预措施: TCI378 (Drug)
TCI507
TCI507 (Lactobacillus plantarum TCI507)
干预措施: TCI507 (Drug)
结局指标
主要结局
To evaluate whether the probiotics TCI378 (Lactobacillus plantarum TCI378) and TCI507 (Lactobacillus plantarum TCI507) have effect on reduction of body weight.
时间窗: 8 weeks
次要结局
未报告次要终点