Randomised, Controlled, Double-blind Clinical Study on the Effect of a Synbiotic on Body Fat Mass, Weight Management, Metabolic Syndrome and Other Risk Factors for CVD and Diabetes, on Fecal Microbiota and Adverse Effects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 4
- 主要终点
- BFM
研究概览
简要总结
In this trial the effect of a synbiotic consisting of the three different strains of Lactobacillus fermentum and acacia gum (gum arabic) on body fat mass, body weight, long-term glycemia, insulin resistance and other risk factors for CVD and diabetes in overweight type 2 diabetics is investigated.
详细描述
The effects of probiotics on glucose and lipid metabolism, on body fat, weight, visceral fat and liver steatosis were shown by several meta-analyses for the total variety, as described above. Some probiotic species/strains, however, seem to be more efficacious. The lactobacilli used in this trial were selected for their anti-inflammatory properties and based on induction of defensins in enterocytes. Therefore, one may expect more pronounced effects of these strains on traits of the metabolic syndrome, which is driven by low grade inflammation, than those found in the meta-analyses for the whole variety of probiotics without discriminating species and strain specificity.
The combination of these Lactobacillus strains with acacia gum is expected to enable even more pronounce effects, since acacia gum was shown to increase the number of lactobacilli in the gut and, hence, are supposed to promote their propagation and, hence their effects. The dosage of 10 g/day acacia gum was demonstrated to be sufficient for enhancing fecal lactobacilli and bifidobacterial.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
盲法说明
Placebo products are identical with verum in smell, flavour, color, texture, appearance, packaging (sachets) and labelling.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Overweight or obese (BMI ≥ 25)
- •Type 2 diabetes
- •Written informed consent
排除标准
- •Any of the following is regarded as a criterion for exclusion from enrollment into the study:
- •Subjects currently enrolled in another clinical study
- •Subjects having finished another clinical study within the last 4 weeks before inclusion
- •Hypersensitivity, allergy or intolerance against any compound of the test products (e. g. acacia gum)
- •Condition after implantation of a cardiac pacemaker or other active implants
- •Antidiabetic drugs except metformin
- •Any disease or condition which might compromise significantly the hepatic (ascites), hematopoietic, renal, endocrine, pulmonary, central nervous, cardiovascular, immunological, dermatological, gastrointestinal or any other body system with the exception of the conditions defined by the inclusion criteria
- •History of hepatitis B, C, HIV
- •History of or present liver deficiency as defined by Quick < 70%
- •Regular medical treatment including OTC, which may have impact on the study aims (e.g. probiotics containing supplements etc.)
- •Major cognitive or psychiatric disorders
- •Subjects who are scheduled to undergo any diagnostic intervention or hospitalization which may cause protocol deviations
- •Simultaneous study participation by members of the same household
- •Pregnancy and lactation
- •Any diet to lose body weight
- •Eating disorders or vegan diet
- •Anorexic drugs and laxatives
- •Present drug abuse or alcoholism
- •Legal incapacity
结局指标
主要结局
BFM
时间窗: 12 weeks
Body Fat Mass (BFM) as assessed by bioelectrical impedance analysis (BIA) (alteration V3-V1; verum versus placebo group)
次要结局
- HbA1c(12 weeks)
- HOMA-IR(12 weeks)