The Evaluation of TCI378 and TCI507 Probiotics on Weight-lowering Efficacy in Adults
试验速览
- 阶段
- 不适用
- 状态
- 进行中（未招募）
- 入组人数
- 96
- 试验地点
- 2
- 主要终点
- The change of LDL-cholestrol
研究概览
简要总结
To assess the evaluation of TCI378 and TCI507 probiotics on weight-lowering efficacy in adults
详细描述
This is a double-blind and randomized study. Subjects are informed to consume the samples every day for 2 months. The person who is evaluated as overweight by the doctor will be invited to participate in this trial. The efficacy assessment items and questionnaires are collected at every visit of the trial.
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, Investigator)
入排标准
- 年龄范围
- 25 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Adults between the ages of 20 and 65 who are willing to sign the consent form of the subject.
- •BMI ≥ 24 or male body fat ≥ 25%, female body fat ≥ 30%.
- •Those who are not pregnant and are willing to cooperate with contraception during the trial period.
- •No history of cardiovascular disease, history of organ transplantation, history of epilepsy or convulsions, liver and kidney disease, malignant tumor, endocrine disease, mental disease, alcohol or drug abuse, or 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 diseases, alcohol or drug abuse, and other major organic diseases (according to medical history).
- •No person who has undergone major surgery or bariatric surgery (according to medical history).
- •Drugs that affect body fat, waist circumference, or significantly increase weight, such as systemic corticosteroids, tricyclic antidepressants, atypical psychiatric drugs, and mood stability, have been used at present or within 3 months before participating in the screening Drugs (according to medical history).
研究组 & 干预措施
Placebo
Placebo
干预措施: Placebo (Dietary Supplement)
TCI378 Probiotics
TCI378 Probiotics
干预措施: TCI378 Probiotics (Dietary Supplement)
TCI507 Probiotics
TCI507 Probiotics
干预措施: TCI507 Probiotics (Dietary Supplement)
结局指标
主要结局
The change of LDL-cholestrol
时间窗: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of LDL-cholestrol
The change of visceral fat
时间窗: Weeks 0, 4 and 8
The visceral fat (10 cm\^2) was assessed by InBody770.
The change of body fat mass
时间窗: Weeks 0, 4 and 8
The body fat mass (kg) was assessed by InBody770
The change of body mass index (BMI)
时间窗: Weeks 0, 4 and 8
BMI is a measurement of a person's leanness or corpulence based on their height and weight, and is intended to quantify tissue mass.The body mass index (BMI, kg/m\^2) and body mass (kg) were assessed by InBody770.
The change of HDL-cholestrol
时间窗: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of HDL-cholestrol
The change of Triglyceride
时间窗: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of Triglyceride
The change of Total cholestrol
时间窗: Weeks 0, 4 and 8
Venous blood was sampled to measure concentrations of Total cholestrol
The change of body fat percentage
时间窗: Weeks 0, 4 and 8
The body fat percentage (%) was assessed by InBody770.
次要结局
- The change of fasting glycemia(Weeks 0, 4 and 8)
- The change of alanine aminotransferase(Weeks 0, 4 and 8)
- The change of albumin(Weeks 0, 4 and 8)
- The change of white blood cell(Weeks 0, 4 and 8)
- The change of aspartate aminotransferase(Weeks 0, 4 and 8)
- The change of creatine(Weeks 0, 4 and 8)
- The change of uric acid(Weeks 0, 4 and 8)