Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults
试验速览
- 阶段
- 不适用
- 状态
- 招募中
- 发起方
- 入组人数
- 48
- 试验地点
- 2
- 主要终点
- Cognitive impairment
研究概览
简要总结
Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.
Several studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.
After multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.
详细描述
Cognitive impairment is one of the fastest growing diseases in the last decades, given the significant increase in senior citizen population in Mexico and the world.
Cognitive impairment is the loss of cognitive functions, in the abscence of other pathologies that may be the cause of the memory loss. It is well known that this pathology can progress to more severe states reaching irreversible dementia such as Alzheimer in a short period of approximately 5 years from the onset of the disease.
Given the rapid increase in incidence of cognitive impairment, there have been several studies on the management of symptoms and on the natural course of the disease.
Several studies have discussed the gut-microbiota-brain axis. It has been demonstrated that a balanced gut microbiota, prevents an increase in pro-inflammatory cytokines that affect specific brain areas; having an important impact at the cortical level of the hippocampus which translates to diminished cognitive function and the start of cognitive impairment symptoms.
After multiple studies on the effect of the administration of symbiotics in animal models in cognition and memory, there have been positive results, observing improvement in cognition and decrement in inflammatory cytokines at hippocampus level.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Prevention
- 盲法
- Triple (Participant, Care Provider, Outcomes Assessor)
入排标准
- 年龄范围
- 70 Years 至 85 Years(Older Adult)
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Patients with mild cognitive impairment
- •Patients who sign the informed consent
排除标准
- •Patients who do not have mild cognitive impairment
- •Patients with advanced cognitive impairment such as Alzheimers disease
- •Patients with comorbidities that influence the cognitive functions such as diabetes mellitus, cerebral ischemia or previous brain trauma
- •Patients who do not sign the informed consent
结局指标
主要结局
Cognitive impairment
时间窗: 8 weeks
Change in Score for Mini mental state examination
次要结局
未报告次要终点
研究者
Jose Juan Antonio Ibarra Arias
Responsable
Anahuac University
