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NCT Number: NCT04924907

Lifestyles, Arterial Aging and 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

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Key information

Age range

45 year–74 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Primary Care Research Unit (APISAL), Salamanca, Spain

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About this study

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)

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Pulse Wave Velocity

    Time frame: 1 year

    Measurement by SphygmoCor System (meters/seg)

Secondary outcomes

  1. Physical Activity

    Time frame: 1 year

    Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day)

  2. Eating habits

    Time frame: 1 year

    Measurement by Food Frequency Questionnaire (FFQ) (kcal/day)

  3. Smoking

    Time frame: 1 year

    Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)

  4. Drinking habits

    Time frame: 1 year

    Measurement by a frequency alcohol questionnaire (units/day)

  5. Body composition

    Time frame: 1 year

    Measurement by Inbody 230 device (kg)

  6. Carotid intima-media thickness (IMT)

    Time frame: 1 year

    Measurement by Sonosite Micromax Ultrasound (mm)

  7. Cardio Ankle Vascular Index (CAVI)

    Time frame: 1 year

    Measurement by Vasera device 2000 (not units)

  8. Cognitive evaluation

    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.

Sponsors and collaborators

Lead sponsor

Instituto de Investigación Biomédica de Salamanca

Other

Collaborators

  • Castilla-León Health Service
  • Instituto de Salud Carlos III

Registry information

Official study title

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

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Jun 14, 2021
Registry last updated
May 31, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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