- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07311967
Short-Term Health Outcomes of Cooking UFP Exposure (UFP)
Study Overview
Status
Detailed Description
This study evaluates the short-term respiratory and cognitive responses to controlled exposure to cooking-generated ultrafine particles (UFPs). Cooking emissions are one of the most common sources of indoor particulate pollution, yet their acute physiological effects remain poorly characterized. To address this gap, the study uses a controlled exposure chamber environment that reproduces typical household cooking conditions while allowing precise measurement of airborne particle and gas concentrations.
Healthy adult volunteers will participate in two study sessions conducted on consecutive days. On the exposure day, research staff will prepare a standardized meal (frying potatoes and grilling beef) inside the chamber to generate UFPs and co-emitted gases at levels representative of home cooking. On the control day, participants remain in the same chamber but without any cooking activity. Participants will spend approximately six hours in the chamber each day and will remain at rest except during scheduled assessments.
The study employs a randomized two-period crossover design so each participant serves as their own control. Lung function and cognitive performance are assessed multiple times on each day using validated instruments. Air quality is monitored continuously using particle sizing instruments, particle mass monitors, and a gas analyzer to characterize exposure conditions. Pre-defined stopping rules and ventilation procedures are implemented if concentrations exceed levels typical of household cooking.
This study is designed to generate preliminary U.S.-based data on the immediate effects of cooking-related UFP exposure on respiratory function and cognitive performance. Findings will help define exposure-response patterns, support future NIH and American Lung Association proposals, and improve understanding of indoor air quality impacts in everyday environments.
Study Type
Enrollment (Estimated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Mehdi Amouei Torkmahalleh, PhD
- Phone Number: 8326077765
- Email: mehdiat@uic.edu
Study Locations
-
-
Illinois
-
Chicago, Illinois, United States, 60612
- UIC
-
Contact:
- Mehdi Amouei Torkmahalleh, PhD
- Phone Number: 8326077765
- Email: mehdiat@uic.edu
-
Sub-Investigator:
- Kyle J. Jennette, PhD
-
Sub-Investigator:
- Leonard H. Go, MD
-
Sub-Investigator:
- Rachel Lane, M.Sc.
-
Sub-Investigator:
- Mahsa Alishiri, M.Sc.
-
Sub-Investigator:
- Emani Cotton, B.Sc.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria
Adults 18 years of age or older
Able to understand and speak English sufficiently to complete cognitive testing
Able and willing to complete two consecutive study sessions lasting approximately 6 hours each
Able to avoid cooking, toasting, and fume-generating household activities (e.g., strong cleaning products, ironing, hair drying) for 24 hours before each session
Able to avoid tobacco, marijuana, vaping, and alcohol use as specified in the study protocol
Able to provide informed consent
Exclusion Criteria
Younger than 18 years old
Pregnant or planning pregnancy during study participation
Current smoking or use of:
Cigarettes
E-cigarettes or vaping devices
Marijuana
Shisha/hookah
Binge drinking, heavy alcohol use, or inability to abstain from alcohol for 24 hours before study visits
Restaurant chefs or individuals who perform frequent commercial-level cooking
Individuals who cook two or more frying or grilling meals per day at home
Cooking anxiety or mageirocophobia
Any diagnosed neurological disease, including stroke, seizure disorder, multiple sclerosis, traumatic brain injury, dementia, or similar conditions
Any significant respiratory disease, including:
Chronic obstructive pulmonary disease (COPD)
Untreated severe asthma
Chronic bronchitis or other major lung disease
Any significant psychiatric condition, including:
Schizophrenia spectrum disorder
Untreated substance use disorder
Severe mood disorder
Severe anxiety disorder
Claustrophobia or anxiety in enclosed spaces (if severe enough to interfere with chamber procedures)
Inability to comply with study procedures or safety requirements
Any medical or psychological condition that, in the judgement of the investigators, may increase risk or interfere with study participation
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Other: Control Condition (Clean Indoor Air)
Participants will complete a control study session conducted in a controlled exposure chamber with clean indoor air and no cooking activity.
Respiratory, cognitive, and physiological outcomes will be assessed during the session.
|
Participants will be exposed to clean indoor air in a controlled exposure chamber with no cooking activity.
This condition serves as the control session for within-subject comparisons.
|
|
Experimental: Cooking Emissions Exposure
Participants will complete an exposure study session conducted in the same controlled exposure chamber during which cooking activities generate ultrafine particles.
Respiratory, cognitive, and physiological outcomes will be assessed during the session.
|
Participants will be exposed to cooking-generated ultrafine particles and associated gases in a controlled exposure chamber during standardized cooking activities.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in Hopkins Verbal Learning Test-Revised (HVLT-R) Total Recall Score
Time Frame: Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
Cognitive performance related to verbal memory will be assessed using the Hopkins Verbal Learning Test-Revised (HVLT-R).
The primary metric will be the change in HVLT-R Total Recall Score between exposure and control conditions, calculated from repeated assessments to evaluate short-term cognitive effects of ultrafine particle exposure.
|
Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
|
Change in Peak Expiratory Flow (PEF)
Time Frame: Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
Peak Expiratory Flow (PEF) will be measured using a handheld peak flow meter to assess short-term changes in lung function following exposure to cooking-generated ultrafine particles compared with the clean-air control day.
Changes are evaluated within subjects using repeated measurements across both conditions.
|
Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
|
Change in WAIS Symbol Search Raw Score
Time Frame: Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
Cognitive performance related to processing speed and visual attention will be assessed using the Symbol Search subtest of the Wechsler Adult Intelligence Scale (WAIS).
The primary metric will be the change in WAIS Symbol Search raw score between exposure and control conditions, calculated from repeated assessments to evaluate short-term cognitive effects of ultrafine particle exposure.
|
Measured at baseline and at approximately 1, 2, 3, and 5 hours after session start on both study days
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Ultrafine Particle Number Size Distribution in particles/cm3
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods.
|
Ultrafine particle number size distributions will be measured using a Scanning Mobility Particle Sizer (SMPS) and Partector 2 Pro.
These measurements characterize exposure conditions and allow correlation with physiological responses.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods.
|
|
Fine Particle Mass Concentrations (PM2.5) in microgram/cm3
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Particle mass concentrations (PM2.5) will be measured using a DustTrak DRX monitor to quantify particulate exposure profiles during cooking and control sessions.
These measurements characterize exposure conditions and allow correlation with physiological responses.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
|
Total Volatile Organic Compound (VOC) concentration in ppm
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Concentrations of over 50 volatile organic compounds (VOCs) will be monitored using FTIR spectroscopy (Gasmet DX4040) to characterize exposure to total VOC concentration during cooking.
The concentration of individual gases will be add up to quantify total VOC concentration.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
|
CO2 concentration in ppm
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Description: Concentrations of CO2 will be monitored using Atmocube, Atmo, USA instrument.
This measurement characterize exposure conditions and allow correlation with physiological responses.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
|
CO concentration in ppm
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Description: Concentrations of CO will be monitored using FTIR spectroscopy (Gasmet DX4040) to characterize exposure to CO during cooking.
The
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
|
NO2 concentration in ppm
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Concentrations of NO2 will be monitored using FTIR spectroscopy (Gasmet DX4040) to characterize exposure to NO2 during cooking.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Temperature Condition in Exposure Chamber
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Ambient temperature will be recorded to ensure environmental conditions remain consistent and to support interpretation of particle behavior.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
|
Number of Participants Reporting Acute Symptoms During Study Sessions
Time Frame: Assessed at baseline and at approximately 1, 2, 3, and 5 hours after session start on control and exposure days
|
Participant-reported symptoms related to tolerability of the study procedures and exposure will be assessed using a standardized symptom checklist administered by study staff.
Symptoms assessed will include throat or eye irritation, cough, headache, dizziness, and nausea.
The outcome measure will be the number of participants reporting one or more symptoms during each study session.
|
Assessed at baseline and at approximately 1, 2, 3, and 5 hours after session start on control and exposure days
|
|
Relative Humidity Condition in Exposure Chamber
Time Frame: Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Relative Humidity in the chamber will be recorded to ensure environmental conditions remain consistent and to support interpretation of particle behavior.
|
Continuously measured average concentration with one minute intervals during each study session on control and exposure days, from session start to session end (approximately 5 hours per session), across both study periods
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Mehdi Amouei Torkmahalleh, PhD, University of Illinois Chicago
Study record dates
Study Major Dates
Study Start (Estimated)
Primary Completion (Estimated)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- STUDY2025-1120
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
Study Data/Documents
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Air Pollution Exposure
-
Emory UniversityNational Institute of Environmental Health Sciences (NIEHS)RecruitingExposure to Environmental Pollution | Exposure to Household Air PollutionCambodia
-
Environmental Protection Agency (EPA)Enrolling by invitationAir Pollution | Pollution; Exposure | Nutrition, HealthyUnited States
-
Lille Catholic UniversityUniversite du Littoral Cote d'OpaleCompletedBiomarkers of Air Pollution ExposureFrance
-
New York University Abu DhabiIQAir AG; LUT UniversityCompletedSleep | Heart Rate | Respiratory Rate | Air Pollution Exposure | SpO2 | HRV | Resting Heart RateUnited Arab Emirates
-
U.S. EPA Human Studies FacilityRecruitingAir PollutionUnited States
-
UConn HealthNational Institute of Environmental Health Sciences (NIEHS)Completed
-
C-Polar InnovationsKelowna General HospitalNot yet recruiting
-
University Hospitals Cleveland Medical CenterPeking University; University of MichiganCompletedAir PollutionUnited States, China
-
Wayne State UniversityNot yet recruitingMild Hypertension | Air Pollution Exposure
-
Alaska Native Tribal Health ConsortiumRecruitingAir Pollution, IndoorUnited States
Clinical Trials on Clean Indoor Air Exposure (Control)
-
Fraunhofer-Institute of Toxicology and Experimental...CompletedHealthy | Chronic Obstructive Pulmonary DiseaseGermany
-
Rutgers, The State University of New JerseyCompletedHealthy ParticipantsUnited States
-
Environmental Protection Agency (EPA)Enrolling by invitationLung Inflammation | Experimental Lung InflammationUnited States
-
University of California, San FranciscoTobacco Related Disease Research ProgramSuspendedPollution; Exposure | Exposure to Pollution | Smoke InhalationUnited States
-
National Taiwan University HospitalUnknownAsthma in ChildrenTaiwan
-
National University of SingaporeNational University Hospital, Singapore; Singapore National Eye Centre; Singapore...Recruiting
-
Environmental Protection Agency (EPA)CompletedExposure to PollutionUnited States
-
Environmental Protection Agency (EPA)CompletedExposure to Environmental Pollution, Non-occupationalUnited States
-
Environmental Protection Agency (EPA)CompletedExposure to Pollution | Inhalation of OzoneUnited States