Intestinal Microbiota and Arterial Stiffness
NCT03900338
Arterial Stiffness, Cardiovascular Diseases
Braga, Portugal
View Trial DetailsNCT Number: NCT04924907
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
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Notify Me45 year–74 year
All sexes
Observational
Primary Care Research Unit (APISAL), Salamanca, Spain
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)
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Time frame: 1 year
Measurement by SphygmoCor System (meters/seg)
Time frame: 1 year
Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day)
Time frame: 1 year
Measurement by Food Frequency Questionnaire (FFQ) (kcal/day)
Time frame: 1 year
Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)
Time frame: 1 year
Measurement by a frequency alcohol questionnaire (units/day)
Time frame: 1 year
Measurement by Inbody 230 device (kg)
Time frame: 1 year
Measurement by Sonosite Micromax Ultrasound (mm)
Time frame: 1 year
Measurement by Vasera device 2000 (not units)
Time frame: 1 year
Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.
Instituto de Investigación Biomédica de Salamanca
Other
Lifestyles, Arterial Aging and Its Relationship With the Intestinal Microbiota (MIVAS III Study)
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