Clinical trial NCT04924907: Lifestyles, Arterial Aging and Intestinal Microbiota (MIVAS III Study)
Official title: Lifestyles, Arterial Aging and Its Relationship With the Intestinal Microbiota (MIVAS III Study)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Arterial Stiffness
Dysbiosis
Keywords: Lifestyles
pulse wave velocity
intestinal microbiota
multicentric study
Lead sponsor: Instituto de Investigación Biomédica de Salamanca
Sponsor class: OTHER
Collaborators: name: Instituto de Salud Carlos III
name: Castilla-León Health Service
First posted: 2021-06-14
Enrollment: 1015
Sex: ALL
Minimum age (years): 45
Maximum age (years): 74
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: PROBABILITY_SAMPLE
Study population: Subjects aged 45 to 74 years without cardiovascular disease

Brief summary: 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: 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)

Eligibility criteria: 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

Primary outcomes:
measure: Pulse Wave Velocity
timeFrame: 1 year
Secondary outcomes:
measure: Physical Activity
timeFrame: 1 year
measure: Eating habits
timeFrame: 1 year
measure: Smoking
timeFrame: 1 year
measure: Drinking habits
timeFrame: 1 year
measure: Body composition
timeFrame: 1 year
measure: Carotid intima-media thickness (IMT)
timeFrame: 1 year
measure: Cardio Ankle Vascular Index (CAVI)
timeFrame: 1 year
measure: Cognitive evaluation
timeFrame: 1 year
Other outcomes:
Locations:
city: Salamanca
country: Spain
facility: Primary Care Research Unit (APISAL)
city: Valladolid
country: Spain
facility: Primary Care Research Unit-Valladolid
Study officials:
affiliation: Primary Care Research Unit of Salamanca (APISAL)
name: Luis Garcia-Ortiz
role: STUDY_DIRECTOR
affiliation: Primary Care Research Unit
name: Rita Salvado-Martins
role: PRINCIPAL_INVESTIGATOR
affiliation: Life and Health Sciences Research Institute in Minho University
name: Pedro Guimaraes-Cunha
role: STUDY_DIRECTOR
References: