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

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

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

Study Overview

• Status: Completed
• Conditions: Dysbiosis; Arterial Stiffness

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)

• Study Type: Observational
• Enrollment (Actual): 1015

Contacts and Locations

• Study Contact: Name: Luis Garcia-Ortiz; Phone Number: 635542886; Email: lgarciao@usal.es

Study Locations

• Spain
  • Salamanca, Spain, 37005
    • Primary Care Research Unit (APISAL)
  • Valladolid, Spain
    • Primary Care Research Unit-Valladolid

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 45 years to 74 years (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Probability Sample

Study Population

Subjects aged 45 to 74 years without cardiovascular disease

Description

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

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
Dysbiosis microbiota; microbiota with proinflammatory pattern or dysbiosis
Normal microbiota; microbiota with antiinflammatory pattern or normal

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: Fundacion para la Investigacion y Formacion en Ciencias de la Salud
• Collaborators: Castilla-León Health Service; Instituto de Salud Carlos III
• Investigators: Study Director: Luis Garcia-Ortiz, Primary Care Research Unit of Salamanca (APISAL); Principal Investigator: Rita Salvado-Martins, Primary Care Research Unit; Study Director: Pedro Guimaraes-Cunha, Life and Health Sciences Research Institute in Minho University

Study record dates

Study Major Dates

• Study Start (Actual): April 21, 2021
• Primary Completion (Actual): December 30, 2023
• Study Completion (Actual): December 31, 2023

Study Registration Dates

• First Submitted: April 25, 2021
• First Submitted That Met QC Criteria: June 11, 2021
• First Posted (Actual): June 14, 2021

Study Record Updates

• Last Update Posted (Actual): April 4, 2024
• Last Update Submitted That Met QC Criteria: April 3, 2024
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Keywords: pulse wave velocity; intestinal microbiota; Lifestyles; multicentric study
• Additional Relevant MeSH Terms: Pathologic Processes; Dysbiosis
• Other Study ID Numbers: PI20/00321; GRS 2148/B/2020 (Other Grant/Funding Number: Gerencia Regional de Salud de Castilla y Leon); GRS 2263/B/2020 (Other Grant/Funding Number: Gerencia Regional de Salud de Castilla y Leon)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No