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

Sponsor

Fundacion para la Investigacion y Formacion en Ciencias de la Salud (Other)

Overall Status

Recruiting

CT.gov ID

NCT04924907

Collaborator

Instituto de Salud Carlos III (Other), Castilla-León Health Service (Other)

800

Enrollment

Locations

32.3

Anticipated Duration (Months)

400

Patients Per Site

12.4

Patients Per Site Per Month

Study Details

Study Description

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

Condition or Disease	Intervention/Treatment	Phase
Arterial Stiffness Dysbiosis

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: 800 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)

Study Design

Study Type:

Observational

Anticipated Enrollment :

800 participants

Observational Model:

Cohort

Time Perspective:

Cross-Sectional

Official Title:

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

Actual Study Start Date :

Apr 21, 2021

Anticipated Primary Completion Date :

Apr 30, 2023

Anticipated Study Completion Date :

Dec 31, 2023

Arms and Interventions

Arm	Intervention/Treatment
Dysbiosis microbiota microbiota with proinflammatory pattern or dysbiosis
Normal microbiota microbiota with antiinflammatory pattern or normal

Outcome Measures

Primary Outcome Measures

Pulse Wave Velocity [1 year]
Measurement by SphygmoCor System (meters/seg)

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

45 Years to 74 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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 diabetes mellitus 1 or 2
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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Primary Care Research Unit (APISAL)	Salamanca		Spain	37005
2	Primary Care Research Unit-Valladolid	Valladolid		Spain

Sponsors and Collaborators

Fundacion para la Investigacion y Formacion en Ciencias de la Salud
Instituto de Salud Carlos III
Castilla-León Health Service

Investigators

Study Director: Luis Garcia-Ortiz, Primary Care Research Unit- La Alamedilla Health Center
Principal Investigator: Rita Salvado-Martins, Primary Care Research Unit
Study Director: Pedro Guimaraes-Cunha, Life and Health Sciences Research Institute in Minho University