Probiotics Against Low Grade Inflammation and Increased Intestinal Permeability in the Elderly.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Probi AB
- 入组人数
- 66
- 试验地点
- 1
- 主要终点
- Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples
研究概览
简要总结
The purpose of this study is to evaluate the ability of a blend of berries and probiotics in reducing low-grade inflammation and intestinal permeability in the elderly. The intervention period is one month. Blood and fecal samples will be collected for analysis at baseline and at the end of the intervention with the aim to analyse possible changes in different parameters at the two timepoints. The participants will also be asked to keep a study diary throughout the study period for the documentation of their intestinal health and as a means for checking compliance.
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
- Triple (Participant, Care Provider, Investigator)
入排标准
- 年龄范围
- 75 Years 至 90 Years（Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age >75 years
- •CRP 2-10 mg/L
- •Ability to fill in a study diary by him/herself
排除标准
- •Intake of antibiotic treatment in the last 4 weeks before inclusion into the study.
- •Currently on corticosteroid treatment
- •Presence of chronic inflammatory disease
研究组 & 干预措施
Placebo
Powder consisting of maltodextrine, treated to resemble the Active product in appearance and taste.
干预措施: Placebo (Dietary Supplement)
Active, only probiotics
Powder consisting of freezedried bacteria at 10 billions cfu/daily dose and maltodextrine, treated to resemble the Active product in appearance and taste.
干预措施: Active, only probiotics (Dietary Supplement)
Active, blend of berries and probiotics
Powder consisting of freezedried berries , probiotics at 10 billions cfu/daily dose and maltodextrine.
干预措施: Active, blend of berries and probiotics (Dietary Supplement)
结局指标
主要结局
Reduced intestinal permebility measured as decline in the levels of zonulin in blood samples
时间窗: All blood markers analysed in the study will be measured at start, before the onset of intervention and 4 weeks later at the end of intervention.
次要结局
未报告次要终点