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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04924907
Enrollment
1015
Registered
2021-06-14
Start date
2021-04-21
Completion date
2023-12-31
Last updated
2024-05-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Arterial Stiffness, Dysbiosis

Keywords

Lifestyles, pulse wave velocity, intestinal microbiota, multicentric study

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)

Interventions

None listed

Sponsors

Instituto de Salud Carlos III
CollaboratorOTHER_GOV
Castilla-León Health Service
CollaboratorOTHER
Instituto de Investigación Biomédica de Salamanca
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
45 Years to 74 Years
Healthy volunteers
Yes

Inclusion criteria

* People aged 45 to74 years who agree to participate in the study and who not meet any of the

Design outcomes

Primary

MeasureTime frameDescription
Pulse Wave Velocity1 yearMeasurement by SphygmoCor System (meters/seg)

Secondary

MeasureTime frameDescription
Cardio Ankle Vascular Index (CAVI)1 yearMeasurement by Vasera device 2000 (not units)
Physical Activity1 yearMeasurement by the International Physical Activity Questionnaire (IPAQ) (min/day)
Eating habits1 yearMeasurement by Food Frequency Questionnaire (FFQ) (kcal/day)
Carotid intima-media thickness (IMT)1 yearMeasurement by Sonosite Micromax Ultrasound (mm)
Drinking habits1 yearMeasurement by a frequency alcohol questionnaire (units/day)
Body composition1 yearMeasurement by Inbody 230 device (kg)
Cognitive evaluation1 yearMeasurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.
Smoking1 yearMeasurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 9, 2026