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

NCT04924907 | Completed

• 3 other identifiers: PI20/00321GRS 2148/B/2020GRS 2263/B/2020
• Study Type: observational
• Target: 1,015
• Locations: 1 country
• Sites: 2

Brief 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

Conditions

Arterial Stiffness; Dysbiosis

Keywords

Lifestyles; pulse wave velocity; intestinal microbiota; multicentric study

Outcome Measures

Primary Outcomes (1)

• Pulse Wave Velocity

  Measurement by SphygmoCor System (meters/seg)

  1 year

Secondary Outcomes (8)

• Physical Activity

  1 year

• Eating habits

  1 year

• Smoking

  1 year

• Drinking habits

  1 year

• Body composition

  1 year

Study Arms (2)

Dysbiosis microbiota

microbiota with proinflammatory pattern or dysbiosis

Normal microbiota

microbiota with antiinflammatory pattern or normal

Eligibility Criteria

• Age: 45 Years - 74 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Subjects aged 45 to 74 years without cardiovascular disease

You may not qualify if:

• 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

Sponsors & Collaborators

• Instituto de Investigación Biomédica de Salamanca: lead
• Instituto de Salud Carlos III: collaborator
• Castilla-León Health Service: collaborator

Study Sites (2)

Primary Care Research Unit (APISAL)

Salamanca, 37005, Spain

Location

Primary Care Research Unit-Valladolid

Valladolid, Spain

Location

Related Publications (1)

• 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.

  PMID: 37457284 DERIVED

Biospecimen

Retention: SAMPLES WITH DNA

Stool

MeSH Terms

Conditions

Dysbiosis

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Luis Garcia-Ortiz

  Primary Care Research Unit of Salamanca (APISAL)

  STUDY DIRECTOR

• Rita Salvado-Martins

  Primary Care Research Unit

  PRINCIPAL INVESTIGATOR

• Pedro Guimaraes-Cunha

  Life and Health Sciences Research Institute in Minho University

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 25, 2021
• First Posted: June 14, 2021
• Study Start: April 21, 2021
• Primary Completion: December 30, 2023
• Study Completion: December 31, 2023
• Last Updated: May 31, 2024

Record last verified: 2023-12

Data Sharing

• IPD Sharing: Will not share

Locations

ES (2)