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

Completed

• Conditions: Dysbiosis; Arterial Stiffness

• Registration Number: NCT04924907
• Lead Sponsor: Instituto de Investigación Biomédica de Salamanca

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)

Study Timeline

• Study Start: 2021-04-21
• Study First Submitted: 2021-04-25
• Study First Submitted QC: 2021-06-11
• Study First Posted: 2021-06-14
• Status Verified: 2023-12
• Primary Completion: 2023-12-30
• Study Completion: 2023-12-31
• Last Update Submitted: 2024-05-30
• Last Update Posted: 2024-05-31

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 1015

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Pulse Wave Velocity	1 year	Measurement by SphygmoCor System (meters/seg)

Secondary Outcome Measures

Name	Time	Method
Eating habits	1 year	Measurement by Food Frequency Questionnaire (FFQ) (kcal/day)
Drinking habits	1 year	Measurement by a frequency alcohol questionnaire (units/day)
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)
Physical Activity	1 year	Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day)
Smoking	1 year	Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)
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.
Body composition	1 year	Measurement by Inbody 230 device (kg)

Trial Locations

Locations (2)

Primary Care Research Unit-Valladolid; 🇪🇸 Valladolid, Spain

Primary Care Research Unit (APISAL); 🇪🇸 Salamanca, Spain