Arterial StiffnessNCT04924907
Lifestyles, Arterial Aging and Intestinal Microbiota (MIVAS III Study)
An observational study of Arterial Stiffness and Dysbiosis, run by Instituto de Investigación Biomédica de Salamanca at 2 sites in Spain.
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. Read more about this study
- Who is it for?
- Ages 45 to 74 yearsHealthy volunteers can take part
- Conditions the study is for
- Arterial Stiffness, Dysbiosis
- How many people
- 1,015 participants
- Where
- 2 sitesSpain
- Study dates
- 21 Apr 2021to 31 Dec 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 45 to 74 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Subjects aged 45 to 74 years without cardiovascular disease
Who may be able to join
- People aged 45 to74 years who agree to participate in the study and who not meet any of the exclusion criteria
Who cannot join
- 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 locations and contacts
2 sites in 1 country.
Spain2 sites
Primary Care Research Unit (APISAL)
Salamanca, 37005
Primary Care Research Unit-Valladolid
Valladolid
About this study
Official title: Lifestyles, Arterial Aging and Its Relationship With the 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
Read the 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)
- Conditions
- Arterial Stiffness, Dysbiosis
- Keywords
- Lifestyles, pulse wave velocity, intestinal microbiota, multicentric study
- Medical subject headings
- Dysbiosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Dysbiosis microbiota | microbiota with proinflammatory pattern or dysbiosis | |
| Normal microbiota | microbiota with antiinflammatory pattern or normal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulse Wave Velocity
Measurement by SphygmoCor System (meters/seg)
Measured: 1 year
Secondary outcomes (8)
Physical Activity
Measurement by the International Physical Activity Questionnaire (IPAQ) (min/day)
Measured: 1 year
Eating habits
Measurement by Food Frequency Questionnaire (FFQ) (kcal/day)
Measured: 1 year
Smoking
Measurement by a questionnaire of four questions adapted from the WHO MONICA study (Smoking status and cigarettes frequency)
Measured: 1 year
Drinking habits
Measurement by a frequency alcohol questionnaire (units/day)
Measured: 1 year
Body composition
Measurement by Inbody 230 device (kg)
Measured: 1 year
Carotid intima-media thickness (IMT)
Measurement by Sonosite Micromax Ultrasound (mm)
Measured: 1 year
Cardio Ankle Vascular Index (CAVI)
Measurement by Vasera device 2000 (not units)
Measured: 1 year
Cognitive evaluation
Measurement by Montreal Cognitive Assessment (MOCA) (points). Range: 0-30 points. A score of 26 points or above is considered normal.
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Jun 2021
- Study start21 Apr 2021
- Primary completion30 Dec 2023
- Study completion31 Dec 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Arterial StiffnessStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 1,015 participants (actual)
Sponsor and investigators
- Lead sponsor
- Instituto de Investigación Biomédica de Salamanca
- Sponsor type
- University, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Castilla-León Health Service
- Responsible party
- Sponsor
- Investigators
- Luis Garcia-Ortiz, Study director, Primary Care Research Unit of Salamanca (APISAL)Rita Salvado-Martins, Principal investigator, Primary Care Research UnitPedro Guimaraes-Cunha, Study director, Life and Health Sciences Research Institute in Minho University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04924907
- Sponsor's protocol ID
- PI20/00321
- Other IDs
- GRS 2148/B/2020, GRS 2263/B/2020
- Status last verified
- Dec 2023
- First submitted
- 25 Apr 2021
- Last updated
- 31 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Lugones-Sanchez C, Santos-Minguez S, Salvado R, Gonzalez-Sanchez S, Tamayo-Morales O, Hoya-Gonzalez A, Ramirez-Manent JI, Magallon-Botaya R, Quesada-Rico JA, Garcia-Cubillas MD, Rodriguez-Sanchez E, Gomez-Marcos MA, Benito-Sanchez R, Mira A, Hernandez-Rivas JM, Garcia-Ortiz L; MIVAS III Researchers Group. Lifestyles, arterial aging, and its relationship with the intestinal and oral microbiota (MIVAS III study): a research protocol for a cross-sectional multicenter study. Front Public Health. 2023 Jun 29;11:1164453. doi: 10.3389/fpubh.2023.1164453. eCollection 2023.
PubMed 37457284
Study at a glance
From the registry record, last updated by the sponsor on 31 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Lifestyles, Arterial Aging and Its Relationship With the Intestinal Microbiota (MIVAS III Study)
- ClinicalTrials.gov ID
- NCT04924907
- Acronym / sponsor ID
- PI20/00321
- Conditions
- Arterial Stiffness, Dysbiosis
- Keywords
- Lifestyles, pulse wave velocity, intestinal microbiota, multicentric study
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,015 participants (actual)
- Lead sponsor
- Instituto de Investigación Biomédica de SalamancaUniversity, hospital or other
- Collaborators
- Instituto de Salud Carlos III, Castilla-León Health Service
- Study start
- 21 Apr 2021 (actual)
- Primary completion
- 30 Dec 2023 (actual)
- Study completion
- 31 Dec 2023 (actual)
- First posted
- 14 Jun 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Dysbiosis microbiota | – | –microbiota with proinflammatory pattern or dysbiosis |
| Normal microbiota | – | –microbiota with antiinflammatory pattern or normal |
Who may qualify
- Ages
- 45 to 74 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Subjects aged 45 to 74 years without cardiovascular disease
Key inclusion criteria (1 listed)
- People aged 45 to74 years who agree to participate in the study and who not meet any of the exclusion criteria
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Pulse Wave Velocity
Time frame: 1 year
Measurement by SphygmoCor System (meters/seg)
8 secondary outcomes
Physical Activity
Time frame: 1 year
Eating habits
Time frame: 1 year
Smoking
Time frame: 1 year
Drinking habits
Time frame: 1 year
Body composition
Time frame: 1 year
Carotid intima-media thickness (IMT)
Time frame: 1 year
Cardio Ankle Vascular Index (CAVI)
Time frame: 1 year
Cognitive evaluation
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 May 2024.
- Derived from this study: PubMed 37457284Lugones-Sanchez C, Santos-Minguez S, Salvado R, Gonzalez-Sanchez S, Tamayo-Morales O, Hoya-Gonzalez A, Ramirez-Manent JI, Magallon-Botaya R, Quesada-Rico JA, Garcia-Cubillas MD, Rodriguez-Sanchez E, Gomez-Marcos MA, Benito-Sanchez R, Mira A, Hernandez-Rivas JM, Garcia-Ortiz L; MIVAS III Researchers Group. Lifestyles, arterial aging, and its relationship with the intestinal and oral microbiota (MIVAS III study): a research protocol for a cross-sectional multicenter study. Front Public Health. 2023 Jun 29;11:1164453. doi: 10.3389/fpubh.2023.1164453. eCollection 2023.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Luis Garcia-Ortiz study director
Primary Care Research Unit of Salamanca (APISAL)
Rita Salvado-Martins principal investigator
Primary Care Research Unit
Pedro Guimaraes-Cunha study director
Life and Health Sciences Research Institute in Minho University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Arterial Stiffness and Dysbiosis, run by Instituto de Investigación Biomédica de Salamanca at 2 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 31 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulse Wave Velocity (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04924907, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 May 2024.