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

Arterial Stiffness Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04924907
• Other study ID #: PI20/00321
• Secondary ID: GRS 2148/B/2020G
• Status: Completed
• Start date: April 21, 2021
• Est. completion date: December 31, 2023

Study information

• Verified date: December 2023
• Source: Instituto de Investigación Biomédica de Salamanca
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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)

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1015
• Est. completion date: December 31, 2023
• Est. primary completion date: December 30, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 45 Years to 74 Years

Eligibility

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

Related Conditions & MeSH terms

• Arterial Stiffness
• Dysbiosis

Locations

Country	Name	City	State
Spain	Primary Care Research Unit (APISAL)	Salamanca
Spain	Primary Care Research Unit-Valladolid	Valladolid

Sponsors (3)

Lead Sponsor	Collaborator
Instituto de Investigación Biomédica de Salamanca	Castilla-León Health Service, Instituto de Salud Carlos III

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pulse Wave Velocity	Measurement by SphygmoCor System (meters/seg)	1 year
Secondary	Physical Activity	Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day)	1 year
Secondary	Eating habits	Measurement by Food Frequency Questionnaire (FFQ) (kcal/day)	1 year
Secondary	Smoking	Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)	1 year
Secondary	Drinking habits	Measurement by a frequency alcohol questionnaire (units/day)	1 year
Secondary	Body composition	Measurement by Inbody 230 device (kg)	1 year
Secondary	Carotid intima-media thickness (IMT)	Measurement by Sonosite Micromax Ultrasound (mm)	1 year
Secondary	Cardio Ankle Vascular Index (CAVI)	Measurement by Vasera device 2000 (not units)	1 year
Secondary	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