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

I

Instituto de Investigación Biomédica de Salamanca

Status

Completed

Conditions

Dysbiosis
Arterial Stiffness

Study type

Observational

Funder types

Other

Identifiers

NCT04924907
PI20/00321
GRS 2148/B/2020 (Other Grant/Funding Number)
GRS 2263/B/2020 (Other Grant/Funding Number)

Details and patient eligibility

About

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

Full 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)

Enrollment

1,015 patients

Sex

All

Ages

45 to 74 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

1,015 participants in 2 patient groups

Dysbiosis microbiota
Description:
microbiota with proinflammatory pattern or dysbiosis
Normal microbiota
Description:
microbiota with antiinflammatory pattern or normal

Trial contacts and locations

2

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Central trial contact

Luis Garcia-Ortiz

Data sourced from clinicaltrials.gov

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