NCT06422013已完成不适用
A Randomized, Double-blind, Placebo-controlled, Parallel-design Clinical Study to Evaluate the Body Fat Reducing Effect and Safety of Lactiplantibacillus Plantarum APsulloc 331261(GTB1)
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Changes of percent body fat(trunk, total ect.)
研究概览
简要总结
This study was conducted to investigate the effects of daily supplementation of GTB1 on decrease of body fat.
详细描述
This study was a 12 week, randomized, double-blind, placebo-controlled human trial. 100 subjects were randomly divided into GTB1 group and placebo group. It is to evaluate the changes in the displayed evaluation items when taking GTB1 once a day, in comparison with taking a placebo.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Other
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Males and females aged between 19~65 years at the screening
- •Participants who were BMI 25.0~34.9 kg/m^2 (Excluding those who need to take or be prescribed medication that affects fat reduction, if the BMI is between 30.0~34.9 kg/m^2)
- •Participants who have a waist circumference of 90 cm for men and 85 cm or more for women
- •Participants who have fully understood the information provided about the study voluntarily decided to participate and agreed to comply with precautions
排除标准
- •Participants who decrease 10% more of weight within 3 months period to the screening
- •Participants who have undergone surgical procedures (such as gastrectomy) for weight loss
- •Participants who have a history of malignant tumors within 5 years prior to participating in the clinical study
- •Participants who have a systolic blood pressure of 160 mmHg or higher, or a diastolic blood pressure of 100 mmHg or higher (those who are stably controlling their blood pressure with medication can participate)
- •Participants who are taking beta-blockers or diuretics as part of their hypertension treatment
- •Patients who have been diagnosed with Type 1 or Type 2 diabetes and are taking oral hypoglycemic agents and insulin
- •Participants who have taken antibiotics within 4 weeks prior to the screening examination
- •Participants who have taken health functional foods, herbal medicine, or general foods for the purpose of weight loss within 4 weeks prior to the screening visit
- •Participants with clinically significant acute or chronic diseases of the cardiovascular system, endocrine system, immune system, respiratory system, liver biliary system, kidney and urinary system, neuropsychiatry system, musculoskeletal system, inflammatory and hematologic, gastrointestinal diseases, and other diseases requiring treatment
- •Participants with a past history of gastrointestinal diseases (e.g., Crohn's disease) or gastrointestinal surgery (but, excluding simple cecal surgery and hernia surgery) that can affect the absorption of products of the human trial
- •Participants who have participated in other clinical study within 3 months prior to the screening examination
- •Women who are pregnant or breastfeeding
- •Women who may become pregnant and have not used appropriate contraceptives
- •Participants who show the following relevant results in a Laboratory test
- •Aspartate Transaminase (AST), Alanine Transaminase (ALT) > Reference range 3 times upper limit
- •Serum Creatinine > 2.0 mg/dl
- •Participants who the principal investigator judged inappropriate for the participant in this study because of a laboratory test result, etc.
结局指标
主要结局
Changes of percent body fat(trunk, total ect.)
时间窗: Baseline, Week 12
Measurement is made using dual-energy X-ray absorptiometry(DEXA)
次要结局
- Changes of indicator of lipid metabolism(Baseline, Week 12)
- Changes of obesity-related hormone index(Baseline, Week 12)
- Changes of fat free mass(trunk, total ect.)(Baseline, Week 12)
- Changes of total abdominal fat area, visceral fat area and subcutaneous fat area(Baseline, Week 12)
- Changes of waist, hip circumference and waist/hip circumference ratio(Baseline, Week 12)
研究者
研究点 (2)
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