PM2.5 Exposure, Obesity, and Cardiovascular Health
Investigating Interactions Between PM2.5 Exposure, Obesity, Cardiovascular Health and Dietary Antioxidant in Subjects With Obesity
Obesity and exposure to fine particulate matter (particles of aerodynamic diameter less than 2.5 µm, PM2.5) air pollution are established risk factors for cardiovascular (CV) morbidity and mortality. This proposed pilot project seeks to assess interactions between PM2.5 exposure, obesity, CV health, and dietary antioxidant in subjects with obesity.
Studieoversikt
Status
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
This proposed intervention study will investigate (1) whether the use of portable air filtration systems (PAFS), by lowering PM2.5 exposures, will improve CV risk factors in subjects with obesity; and (2) whether antioxidant levels will modify the association between PM2.5 exposure and blood pressure. Our project will help validate the benefits of novel strategies to employ PAFS. Positive results would represent a key step in forming the evidence base required to promote more wide-scale PAFS use; in the long term, given their low cost and burden, PAFS use could be up-scaled to help protect diverse populations.
Studietype
Registrering (Antatt)
Fase
- Ikke aktuelt
Kontakter og plasseringer
Studiesteder
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Michigan
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East Lansing, Michigan, Forente stater, 48824
- Rekruttering
- Michigan State University
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Ta kontakt med:
- Study coordinator
- Telefonnummer: 517-884-4068
- E-post: klaverza@msu.edu
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Deltakelseskriterier
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
Tar imot friske frivillige
Kjønn som er kvalifisert for studier
Beskrivelse
Inclusion Criteria:
- ≥21 years old
- diagnosis of hypertension (BP ≥140/90 mm Hg)
- obesity (BMI>30)
Exclusion Criteria:
- any CV event (myocardial infarction, stroke, heart failure) in the past 3 months
- unstable CV condition (class 3-4 angina or heart failure) or any medical condition that would place the subject at risk from participation or jeopardize study integrity (per investigators)
- expected overnight travel outside their home during the 9-week study period
- unable to comprehend/sign informed consent
- lung disease requiring oxygen
- cancer receiving active treatment or chemotherapy
- CPAP use for sleep apnea
- CV medication change in the prior month
Studieplan
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Grunnvitenskap
- Tildeling: Randomisert
- Intervensjonsmodell: Crossover-oppdrag
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Sham-komparator: Arm 1
Participants are exposed to unfiltered air (sham) via air filtration systems in the bedroom and main living space of each residence. |
Subjects were exposed to high-efficiency filtered air. |
|
Aktiv komparator: Arm 2
Participants were exposed to high-efficiency (HEPA) filtered air via air filtration systems in the bedroom and main living space of each residence. |
Subjects were exposed to high-efficiency filtered air. |
Hva måler studien?
Primære resultatmål
Resultatmål |
Tidsramme |
|---|---|
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Brachial blood pressure
Tidsramme: Daily for 28 days, between 8-10 AM, starting 24 hours after air filtration systems are placed
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Daily for 28 days, between 8-10 AM, starting 24 hours after air filtration systems are placed
|
Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
C-reactive protein
Tidsramme: Day 1 and Day 28 of each 4-week intervention period.
|
Blood samples for inflammatory marker (high-sensitivity C-reactive protein) |
Day 1 and Day 28 of each 4-week intervention period.
|
|
Carotenoid
Tidsramme: Day 1 and Day 28 of each 4-week intervention period.
|
non-invasive optical measurement of skin carotenoid levels |
Day 1 and Day 28 of each 4-week intervention period.
|
Samarbeidspartnere og etterforskere
Sponsor
Studierekorddatoer
Studer hoveddatoer
Studiestart (Faktiske)
Primær fullføring (Antatt)
Studiet fullført (Antatt)
Datoer for studieregistrering
Først innsendt
Først innsendt som oppfylte QC-kriteriene
Først lagt ut (Faktiske)
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
Siste oppdatering sendt inn som oppfylte QC-kriteriene
Sist bekreftet
Mer informasjon
Begreper knyttet til denne studien
Andre studie-ID-numre
- CH-MSU Alliance
Plan for individuelle deltakerdata (IPD)
Planlegger du å dele individuelle deltakerdata (IPD)?
Legemiddel- og utstyrsinformasjon, studiedokumenter
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