Lifestyles, Arterial Aging and Intestinal Microbiota (MIVAS III Study)

Study Overview
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Brief Summary
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This is an observational cross-sectional study whose objective is to analyse associations between the intestinal and salivate microbiota with lifestyles (eating patterns, physical activity, tobacco and alcohol consumption), arterial aging and cognitive function. It will take place in five different research units located in Spain

Detailed Description
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Aim: To analyze the association of lifestyles (eating patterns, physical activity, tobacco and alcohol consumption) with the intestinal and salivate microbiota and its relationship with arterial aging and cognitive function in subjects without cardiovascular disease in Spain and Portugal. In addition, the mediating role of the intestinal microbiota in the relationship of lifestyles with arterial aging and cognitive function will be analyzed. Design: A cross-sectional study with a case-control analysis, to analyze the association of microbiota patterns with arterial ageing. Setting: the study will develop the research network in health prevention and promotion (Rediapp) and in the Iberian network on arterial structure and the Cancer Research Center of Salamanca. Study population: 1000 subjects aged 45 to 74 years without cardiovascular disease, will be selected. Variables: Demographic, anthropometric and habits (tobacco and alcohol). A dietary pattern through a frequency consumption questionnaire (FFQ), the software of the EVIDENT III and the Mediterranean Diet adherence questionnaire. Physical activity: International Physical Activity Questionnaire (IPAQ), Marshall Questionnaire and Accelerometer, Actigraph. Body composition (Inbody 230 impedance meter). Arterial aging: Medium intimate carotid thickness (Sonosite Micromax); Analysis (PWA) and pulse wave velocity (cf-PWV), (Sphygmocor System). Cardio Ankle Vascular Index (CAVI), ba-PWV and ankle-brachial index (Vasera VS-2000®). With Ambulatory Pulse Wave Analysis (Microsoft®), the PAIx and CAIx and the heart rate variability will be measured. The vascular damage in the retina, heart, kidney, brain and cardiovascular risk will be measured. Intestinal microbiota with the OMNIgene GUT kit (OMR -200) and analysis of the 16S rRNA microbiome profile by massive sequentiation. (Lifestyles, arterial aging, neurocognition, microbiota)

Official Title
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Lifestyles, Arterial Aging and Its Relationship With the Intestinal Microbiota (MIVAS III Study)

Conditions
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Arterial Stiffness, Dysbiosis

Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: People aged 45 to74 years who agree to participate in the study and who not meet any of the exclusion criteria Exclusion Criteria: Participants with a personal history of cardiovascular disease (ischaemic heart disease or stroke, peripheral arterial disease or Heart Failure) Participants with a BMI> 40 kg / m2 Participants diagnosed renal failure in terminal stages (GFR <30 ml / min); Chronic intestinal inflammatory disease or acute inflammatory process in the past 3 months Oncology disease diagnosed in the last 5 years or with active treatment Participants who are in a terminal condition Consumption of antibiotics last 15 days

Ages Eligible for Study
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Minimum Age: 45 Years
Maximum Age: 74 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dysbiosis microbiota<br>microbiota with proinflammatory pattern or dysbiosis | |
| Normal microbiota<br>microbiota with antiinflammatory pattern or normal | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pulse Wave Velocity | Measurement by SphygmoCor System (meters/seg) | 1 year | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Physical Activity | Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day) | 1 year | 
| Eating habits | Measurement by Food Frequency Questionnaire (FFQ) (kcal/day) | 1 year | 
| Smoking | Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency) | 1 year | 
| Drinking habits | Measurement by a frequency alcohol questionnaire (units/day) | 1 year | 
| Body composition | Measurement by Inbody 230 device (kg) | 1 year | 
| Carotid intima-media thickness (IMT) | Measurement by Sonosite Micromax Ultrasound (mm) | 1 year | 
| Cardio Ankle Vascular Index (CAVI) | Measurement by Vasera device 2000 (not units) | 1 year | 
| Cognitive evaluation | Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal. | 1 year | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lifestyles, pulse wave velocity, intestinal microbiota, multicentric study