NCT03774381已完成不适用
Effect of Bifidobacterium Breve B-3 on Body Fat in Obese Adults
适应症
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Body fat
研究概览
简要总结
Comparison of a randomized, double-blind, and control-group study for the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in obese adults
详细描述
Our aim is to investigate the effect of oral ingestion of Bifidobacterium breve B-3 on body fat reduction in adults by a randomized, double-blind, and control-group study.
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
- 20 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •BMI 27~30 kg/m2
排除标准
- •Within the last 6 months, severe cerebrovascular disease (cerebral infarction, cerebral hemorrhage, etc.), heart disease(Angina pectoris, myocardial infarction, heart failure, arrhythmia requiring treatment), or malignant diseases (however, although subjects have a history of cerebrovascular disease and heart disease, they can be included if their status are clinically stable)
- •Patients with uncontrolled hypertension (blood pressure greater than 160/100 mmHg)
- •Diabetic patients with poor glycemic control with a fasting blood glucose of 160 mg/dl or more
- •Those who are treated with hypothyroidism or hyperthyroidism
- •Creatinine levels: more than twice the normal upper limit
- •Aspartate transaminase (AST), Alanine transaminase (ALT) levels: more than twice the normal upper limit
- •Those complaining of severe gastrointestinal symptoms such as heartburn and indigestion
- •Drugs that affect weight within the last month (absorption inhibitors and Appetite suppressant, health food / supplements related to obesity improvement, psychiatric Drugs, beta blockers, diuretics, birth control pills, steroids, female hormones) If you are taking
- •Participated in the commercial obesity program within the last 3 months.
- •If you have participated or are planning to participate in another clinical trial within the past month If yes
- •Alcohol abuser
- •Smoking abstinence within 3 months
- •If they are pregnant or lactating or have a pregnancy plan during the clinical trial
- •Those with allergic reactions to the constituent food
- •Any person deemed inappropriate by the researcher for other reasons
研究组 & 干预措施
Bifidobacterium breve B-3 group
Experimental
160 mg mg of Bifidobacterium breve B-3 was orally administered per day for 12 weeks.
干预措施: Bifidobacterium breve B-3 (Dietary Supplement)
Control group
Placebo Comparator
160 mg of placebo was orally administered per day for 12 weeks.
干预措施: Control group (Dietary Supplement)
结局指标
主要结局
Body fat
时间窗: Change from baseline body fat at 12 weeks
dual energy x-ray absorptiometry (DEXA)
次要结局
未报告次要终点
研究者
Sang Yeoup Lee
Professor
Pusan National University Yangsan Hospital
研究点 (1)
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