Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults

Study Overview
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Brief Summary
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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.

Detailed Description
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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. The objective of this study is to evaluate the effect of the symbiotic on the cognitive process in senior adults. To achieve this a clinical trial will be held in a senior citizen population who will be administered a symbiotic compound (enterococcus faecium and inulin) for 8 weeks and evaluated for cognitive functions using Mini-mental state examination, rey-osterrieth complex, and a validated tool (AeRAC). The variables will be expressed as mean ± standard deviation, depending on the type of distribution of the data. It will be used paired T Student for homogenous data in an intragroup comparison or Wilcoxon test for heterogenous data. For intergroup comparison it will be used independent T Student for homogenous data and U Mann Whitney for dependent group in heterogenous data. Data analysis will be carried out using the latest version of GraphPad Prism.

Official Title
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Effect of the Administration of a Symbiotic (E. Faecium and Agave Inulin) on Mild Cognitive Impairment in Older Adults

Conditions
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Cognitive Impairment

Intervention / Treatment
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* Dietary Supplement: Enteroccocus Facieum and Agave Inulin
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with mild cognitive impairment Patients who sign the informed consent Exclusion Criteria: 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

Ages Eligible for Study
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Minimum Age: 70 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Experimental group<br> | Dietary Supplement: Enteroccocus Facieum and Agave Inulin<br>* A pack of symbiotic powder with 1 gram of e. facieum and 8g of agave inulin will be administered daily for 8 weeks<br>|
| Placebo Comparator: Control group<br> | Other: Placebo<br>* A pack of unsweetened almond powder milk will be administered daily for 8 weeks<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cognitive impairment | Change in Score for Mini mental state examination | 8 weeks | 
| Cognitive impairment | Change in Score for Rey-Osterrieth complex figure | 8 weeks | 
| Cognitive impairment | Change in Score for AeRAC (Instrumento de expectativas de autoeficacia) | 8 weeks |