InflammationNCT05278910
Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying
A study testing Soybean oil + Roasted wheat flour, Fish oil + Roasted wheat flour and Soybean oil + Vegetable and fruit extracts in people with Inflammation, run by Academia Sinica, Taiwan.
Trial summary
Cooking oil fume (COF) is a significant source of PM2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. Modern Chinese cooking produces high concentration of COF especially from deep-frying foods and stirred frying. Read more about this study
- Who is it for?
- Ages 20 years and older
- Conditions the study is for
- Inflammation
- What is being tested?
- Soybean oil + Roasted wheat flour, Fish oil + Roasted wheat flour and Soybean oil + Vegetable and fruit extracts
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- No sites listed yet
- Study dates
- 14 Mar 2022to 31 Dec 2024
- Phase
- Interventional
- 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 20 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- Acute diseases in the past 2 weeks
- Taking anti-oxidant supplements in the past month
- Taking steroid or non-steroidal anti-inflammatory drugs (such as Aspirin and Panadol) in the past week
- Under hormone replacement therapy
- Cancer and other severe diseases
Trial locations and contacts
No sites are listed yet.
About this study
Cooking oil fume (COF) is a significant source of PM2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. Modern Chinese cooking produces high concentration of COF especially from deep-frying foods and stirred frying. Emission from high-temperature frying has been classified by the IARC as Group 2A carcinogen. Cooks are at high risk of exposure to toxic compounds from cooking fumes. However, more of the COF-related studies focused on the home kitchen and less addresses the problems in the restaurants. Studying health hazards and biomarkers of cooks may provide opportunities to understand biological mechanisms and to search and test efficacy for measures to overturn such risks.
The investigators will recruit 80 cooks who handle deep-frying and stirred frying on daily basis. The 80 cooks will be randomized to 4 groups: (1) control, (2) vegetable and fruits extract (V\&F) group, (3) fish oil group, and (4) V\&F-fish oil group will be provided to the participants for 2 months V\&F capsules (equivalent to 4 servings a day) and fish oil capsules (1~1.5 serving a day) and placebos of the same appearance. Heart rate variability (HRV), pulmonary functions, bio-markers, oxylipins and metabolomics profile will be measured as outcomes.
- Conditions
- Inflammation
- Being tested
- Soybean oil + Roasted wheat flour, Fish oil + Roasted wheat flour, Soybean oil + Vegetable and fruit extracts, Fish oil + Vegetable and fruit extracts
- Medical subject headings
- Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Soybean oil + Roasted wheat flourOther
Assign soybean oil capsule and roasted wheat flour
Fish oil + Roasted wheat flourDietary supplement
Assign fish oil and roasted wheat flour
Soybean oil + Vegetable and fruit extractsDietary supplement
Assign soybean oil and vegetable and fruit extracts
Fish oil + Vegetable and fruit extractsDietary supplement
Assign fish oil and vegetable and fruit extracts
| Study group | Role | What they receive |
|---|---|---|
| Soybean oil + Roasted wheat flour | Placebo comparator | Assign soybean oil capsule and roasted wheat flour. Receives: Other: Soybean oil + Roasted wheat flour |
| Fish oil + Roasted wheat flour | Experimental | Assign fish oil capsule and roasted wheat flour. Receives: Dietary Supplement: Fish oil + Roasted wheat flour |
| Soybean oil + Vegetable and fruit extracts | Experimental | Assign soybean oil capsule and Vegetable and fruit extracts. Receives: Dietary Supplement: Soybean oil + Vegetable and fruit extracts |
| Fish oil + Vegetable and fruit extracts | Experimental | Assign fish oil capsule and Vegetable and fruit extracts. Receives: Dietary Supplement: Fish oil + Vegetable and fruit extracts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in HRV
Change in heart rate variability (HRV)
Measured: baseline and 2 months later
Change in pulmonary functions (TLC)
Change in TLC in L
Measured: baseline and 2 months later
Change in pulmonary functions (FVC)
Change in FVC in L
Measured: baseline and 2 months later
Change in pulmonary functions (FEV1)
Change in FEV1 in L
Measured: baseline and 2 months later
Change in pulmonary functions (PEF)
Change in PEF in L/sec
Measured: baseline and 2 months later
Change in pulmonary functions (FEF)
Change in FEF in L/sec
Measured: baseline and 2 months later
Change in oxidative stress marker
Change in urinary 8-OHdG for DNA damage
Measured: baseline and 2 months later
Change from baseline in concentrations of inflammatory markers
Inflammatory markers include IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12, IL-13, IL-17A, IL-23, IL-33, TNF- α, IFN-γ, CXCL1, CXCL9, and CXCL10 (IP-10) in blood
Measured: baseline and 2 months later
Secondary outcomes (6)
Change in blood cell count
Blood cell count is measured by Completed Blood Count Test
Measured: baseline and 2 months later
Change in blood cholesterol markers
Blood cholesterol markers include HDL in mg/dL, LDL in mg/dL, TG in mg/dL and total cholesterol in mg/dL
Measured: baseline and 2 months later
Change in blood sugar (HbA1C)
Change in HbA1C in %
Measured: baseline and 2 months later
Change in blood sugar (glucose)
Change in glucose in mg/dL
Measured: baseline and 2 months later
Change in liver function
The markers of liver function include GOT in U/L and GPT in U/L
Measured: baseline and 2 months later
Change in kidney function
The markers of kidney function include creatinine in mg/dL, uric acid in mg/dL, BUN in mg/dL, microalbumin in mg/dL
Measured: baseline and 2 months later
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Mar 2022
- Study start14 Mar 2022 (estimated)
- Primary completion31 Dec 2024 (estimated)
- Study completion31 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for InflammationStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Academia Sinica, Taiwan
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wen-Harn Pan, Academia Sinica, Taiwan
- Investigators
- Wen-Harn Pan, PhD, Principal investigator, Institute of Biomedical Sciences, Academia Sinica
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05278910
- Sponsor's protocol ID
- AS-IRB01-21006
- Status last verified
- Mar 2022
- First submitted
- 16 Jan 2022
- Last updated
- 14 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Innovative Methods to Reduce Emissions and Health Impacts of Deep-frying
- ClinicalTrials.gov ID
- NCT05278910
- Acronym / sponsor ID
- AS-IRB01-21006
- Conditions
- Inflammation
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Academia Sinica, TaiwanUniversity, hospital or other
- Study start
- 14 Mar 2022 (estimated)
- Primary completion
- 31 Dec 2024 (estimated)
- Study completion
- 31 Dec 2024 (estimated)
- First posted
- 14 Mar 2022 (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.
Cooking oil fume (COF) is a significant source of PM2.5 for poorly ventilated space indoors and in urban streets near restaurants or night markets. Modern Chinese cooking produces high concentration of COF especially from deep-frying foods and stirred frying. Emission from high-temperature frying has been classified by the IARC as Group 2A carcinogen. Cooks are at high risk of exposure to toxic compounds from cooking fumes. However, more of the COF-related studies focused on the home kitchen and less addresses the problems in the restaurants. Studying health hazards and biomarkers of cooks may provide opportunities to understand biological mechanisms and to search and test efficacy for measures to overturn such risks.
The investigators will recruit 80 cooks who handle deep-frying and stirred frying on daily basis. The 80 cooks will be randomized to 4 groups: (1) control, (2) vegetable and fruits extract (V\&F) group, (3) fish oil group, and (4) V\&F-fish oil group will be provided to the participants for 2 months V\&F capsules (equivalent to 4 servings a day) and fish oil capsules (1~1.5 serving a day) and placebos of the same appearance. Heart rate variability (HRV), pulmonary functions, bio-markers, oxylipins and metabolomics profile will be measured as outcomes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Soybean oil + Roasted wheat flour | Placebo comparator | Other: Soybean oil + Roasted wheat flourAssign soybean oil capsule and roasted wheat flour. |
| Fish oil + Roasted wheat flour | Experimental | Dietary Supplement: Fish oil + Roasted wheat flourAssign fish oil capsule and roasted wheat flour. |
| Soybean oil + Vegetable and fruit extracts | Experimental | Dietary Supplement: Soybean oil + Vegetable and fruit extractsAssign soybean oil capsule and Vegetable and fruit extracts. |
| Fish oil + Vegetable and fruit extracts | Experimental | Dietary Supplement: Fish oil + Vegetable and fruit extractsAssign fish oil capsule and Vegetable and fruit extracts. |
Who may qualify
- Ages
- 20 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (5 listed)
- Acute diseases in the past 2 weeks
- Taking anti-oxidant supplements in the past month
- Taking steroid or non-steroidal anti-inflammatory drugs (such as Aspirin and Panadol) in the past week
- Under hormone replacement therapy
- Cancer and other severe diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Soybean oil + Roasted wheat flourAssign soybean oil capsule and roasted wheat flour | Other | Soybean oil + Roasted wheat flour |
| Fish oil + Roasted wheat flourAssign fish oil and roasted wheat flour | Dietary supplement | Fish oil + Roasted wheat flour |
| Soybean oil + Vegetable and fruit extractsAssign soybean oil and vegetable and fruit extracts | Dietary supplement | Soybean oil + Vegetable and fruit extracts |
| Fish oil + Vegetable and fruit extractsAssign fish oil and vegetable and fruit extracts | Dietary supplement | Fish oil + Vegetable and fruit extracts |
Primary outcome
Change in HRV
Time frame: baseline and 2 months later
Change in heart rate variability (HRV)
Change in pulmonary functions (TLC)
Time frame: baseline and 2 months later
Change in TLC in L
Change in pulmonary functions (FVC)
Time frame: baseline and 2 months later
Change in FVC in L
Change in pulmonary functions (FEV1)
Time frame: baseline and 2 months later
Change in FEV1 in L
Change in pulmonary functions (PEF)
Time frame: baseline and 2 months later
Change in PEF in L/sec
Change in pulmonary functions (FEF)
Time frame: baseline and 2 months later
Change in FEF in L/sec
Change in oxidative stress marker
Time frame: baseline and 2 months later
Change in urinary 8-OHdG for DNA damage
Change from baseline in concentrations of inflammatory markers
Time frame: baseline and 2 months later
Inflammatory markers include IL-1β, IL-2, IL-4, IL-6, IL-10, IL-12, IL-13, IL-17A, IL-23, IL-33, TNF- α, IFN-γ, CXCL1, CXCL9, and CXCL10 (IP-10) in blood
6 secondary outcomes
Change in blood cell count
Time frame: baseline and 2 months later
Change in blood cholesterol markers
Time frame: baseline and 2 months later
Change in blood sugar (HbA1C)
Time frame: baseline and 2 months later
Change in blood sugar (glucose)
Time frame: baseline and 2 months later
Change in liver function
Time frame: baseline and 2 months later
Change in kidney function
Time frame: baseline and 2 months later
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Mar 2022.
Related trials for Inflammation
Not yet recruitingPhase 2/3
A Pivotal Safety and Immunogenicity GBS-NN/NN2 Vaccine Maternal Immunisation Trial
Streptococcus Agalactiae Infection, Neonatal Sepsis
RecruitingPhase 1
Pilot Study to Identify the Mediators and Inflammatory Cell Surface Receptors Involved in Allergic Airway Inflammation
Asthma
RecruitingPhase 4
Lidocaine Infiltration and Neuroimmunomodulation in Head and Neck Cancer Surgery
Head and Neck Cancer (H&N)
Active, not recruiting
CT for Personalized Mechanical Ventilation
Ventilator-Induced Lung Injury, Sepsis Syndrome
RecruitingPhase 4
A Study to Compare the Efficacy and Safety of Extended and Intermittent Infusion of Beta-lactams in Critically Ill Paediatric Patients
Infection, Sepsis
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.
Wen-Harn Pan, PhD principal investigator
Institute of Biomedical Sciences, Academia Sinica
Questions about this trial
What is this clinical trial studying?
A study testing Soybean oil + Roasted wheat flour, Fish oil + Roasted wheat flour and Soybean oil + Vegetable and fruit extracts in people with Inflammation, run by Academia Sinica, Taiwan.
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 0 inclusion and 5 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: status not confirmed, as of the sponsor's last update on 14 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Shu-Haur Hsieh, MS (886-2-27899121, d83425@ibms.sinica.edu.tw), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in HRV (time frame: baseline and 2 months later). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Mar 2022.