Randomized, Double Blind, Placebo Controlled Study to Evaluate the Safety and Efficacy of a Live and Heat Treated Bacteria Strain on Body Composition in Overweight Individuals
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 180
- 试验地点
- 1
- 主要终点
- Change in visceral fat area
研究概览
简要总结
Investigate the effect of a probiotic (live bacteria) and postbiotic (heat-treated bacteria) strains in overweight individuals.
详细描述
This study aims to investigate the safety and efficacy of live and heat treated bacteria on body composition of overweight individuals. The trial will be run in a single research centre and will recruit adult men and women, with BMI of 25-33kg/m2 with abdominal obesity.
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
- 19 Years 至 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Body mass index 25-33kg/m2
- •Abdominal obesity (female waist circumference>85cm; male waist circumference>90cm)
- •written informed consent
排除标准
- •Taking the following medication within 1 month before starting the study: appetite stimulants/suppressants, lipid lowering drug, contraceptive
- •taking antibiotics within 2 months before starting the study
- •secondary obesity or secondary hypertension, diabetes type 1, GI disease, dyslipidaemia, type 2diabetes, hypertension
- •consumption of pre- and probiotic-enriched products or dietary supplement for at least 4 weeks prior to the first screening visit
- •nicotine, drug or alcohol abuse,
- •other condition that, in the opinion of the investigators, would make participation not in the best interest of the patient or could prevent, limit or confound the Study's results
研究组 & 干预措施
Postbiotic
Heat treated bacteria strain in a form of a capsule daily for 16 weeks
干预措施: Postbiotic (Dietary Supplement)
Placebo
Placebo in a form of a capsule administered for 16 weeks
干预措施: Placebo (Other)
Probiotic
Live bacteria strain in a form of a capsule daily for 16 weeks
干预措施: Probiotic (Dietary Supplement)
结局指标
主要结局
Change in visceral fat area
时间窗: From week 0 to Week 16
Difference in visceral fat area (cm\^2) measured using CT from week 0 to week 16
次要结局
- Change in waist circumference(Week 0, Week 12, Week 16)
- Change in serum insulin concentration(Week 0, Week 16)
- Change in peripheral blood cholesterol(Week 0, Week 16)
- Microbiome analysis(Week 0, Week 16)
- Change in peripheral blood glucose(Week 0, Week 16)
- Change in plasma leptin levels(Week 0, Week 16)
- Change in body weight(Week 0, Week 12, Week 16)
- Change in body fat composition(Week 0, Week 12, Week 16)
- Dietary survey(Week 0, Week 16)
- Mood questionnaire(Week 0, Week 16)