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The goal of this clinical trial is to evaluate the independent and synergistic effects of liquefied petroleum gas (LPG) substitution and improved ventilation on household air pollution (HAP) reduction and cardiopulmonary health. The main questions it aims to answer are:
Participants will be randomized in 4 groups:
A: Solid fuel + no ventilation facilities group (300 households): Continued use of solid fuels without installation of ventilation facilities and receipt of standardized health education. No LPG stoves or ventilation equipment will be provided during the intervention period. However, after the primary endpoint assessment at 12 months, all households in Group A will be provided with LPG stoves and ventilation facilities of equivalent specifications free of charge, along with health guidance. Phased cash compensation will be provided during the intervention period.
B: Liquefied petroleum gas (LPG) + no ventilation facilities group (300 households): Provided with LPG stoves and instructed to use them during cooking, with regular LPG supply throughout the intervention period. Participants will also receive standardized health education.
C: Solid fuel + ventilation facilities group (300 households): Continued use of solid fuels while being provided with ventilation facilities and instructed to use them during cooking. Electricity costs will be compensated during the intervention period. Participants will also receive standardized health education.
D: LPG + ventilation facilities group (300 households): Provided with both LPG stoves and ventilation facilities and instructed to use both during cooking. Regular LPG supply and electricity cost compensation will be provided throughout the intervention period. Participants will also receive standardized health education.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Solid fuel + no ventilation (control). | Other | Solid fuel + no ventilation facilities group: Continued use of solid fuels without installation of ventilation facilities and receipt of standardized health education. No LPG stoves or ventilation equipment will be provided during the intervention period. However, after the primary endpoint assessment at 12 months, all households in Group A will be provided with LPG stoves and ventilation facilities of equivalent specifications free of charge, along with health guidance. Phased cash compensation will be provided during the intervention period. |
|
| B: LPG + no ventilation. | Experimental | Liquefied petroleum gas (LPG) + no ventilation facilities group: Provided with LPG stoves and instructed to use them during cooking, with regular LPG supply throughout the intervention period. Participants will also receive standardized health education. |
|
| C: Solid fuel + ventilation. | Experimental | Solid fuel + ventilation facilities group: Continued use of solid fuels while being provided with ventilation facilities and instructed to use them during cooking. Electricity costs will be compensated during the intervention period. Participants will also receive standardized health education. |
|
| D: LPG + ventilation. | Experimental |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Cooking ventilation facilities | Device | Installation and use of kitchen ventilation facilities (e.g., range hood) during cooking to reduce indoor air pollution exposure. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Number of Ultrafine particles (UFP) | Unit: particles/cm³, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of PM2.5 | Unit: ug/m3, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Bbair (Yuanrui Environmental Protection Technology Co., Ltd, China) , Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Heart Rate Variability (HRV) Measured by 12-lead ECG | Heart rate variability measured using standard 12-lead electrocardiogram (ECG). Measuring instrument: HeaLink heart rate sensor (Henan Link Medical Technology Co., Ltd., China), The time-domain indicators include:SDNN: Standard deviation of all normal-to-normal (NN) intervals over 24 hours / SDANN: Standard deviation of the average NN intervals calculated over 5-minute segments throughout 24 hours / RMSSD: Root mean square of successive differences between adjacent NN intervals over 24 hours. The frequency-domain indicators include: TP: Total power / LF: Low-frequency power / HF: High-frequency power / LF/HF: Ratio of low-frequency to high-frequency power. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Forced Vital Capacity (FVC) | Forced Vital Capacity measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Forced Expiratory Volume in 1 Second (FEV1) | Forced Expiratory Volume in 1 Second measured using spirometer (HI105; Chestgraph, Japan). Units of Measure: Liters. Method of Measurement: Standardized spirometric testing protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Concentrations of Specific Chemical Components in Particulate Matter | Unit: ug/m3, Measuring instrument: Gilian (Sensidyne, USA), PEM-2-2.5 (MSP,USA), Measurement method: ICP-MS (Inductively Coupled Plasma Mass Spectrometry) and GC-MS/MS (Gas Chromatography-Tandem Mass Spectrometry). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in the Serum Levels of Myocardial Function Biomarkers (BNP, NT-proBNP, Follistatin, Myoglobin, CK-MB, Troponin I, Troponin T) | Units (e.g., pg/mL or ng/mL) depend on the specific analyte and assay standard. Serum concentrations of the following myocardial function biomarkers will be measured: B-type Natriuretic Peptide (BNP), N-terminal prohormone BNP (NT-proBNP) , Follistatin, Myoglobin, Creatine Kinase-MB (CK-MB), Troponin I, Troponin T, Method: MILLIPLEX: serum; |
Inclusion Criteria Primary Participants：
Secondary Participants:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kuai Yu | Contact | +86 15172473088 | yukuai5200@163.com | |
| Hao Wang | Contact | +8618623910286 | wanghaogongwei@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Kuai Yu | Huazhong University of Science and Technology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Suiping County Health Center | Not yet recruiting | Zhumadian | Henan | 4630000 | China |
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LPG + ventilation facilities group: Provided with both LPG stoves and ventilation facilities and instructed to use both during cooking. Regular LPG supply and electricity cost compensation will be provided throughout the intervention period. Participants will also receive standardized health education. |
|
| Using liquefied gas for cooking | Behavioral | Households are provided with liquefied gas stoves and encouraged to use liquefied gas instead of solid fuels for cooking. |
|
| Using solid fuels for cooking | Behavioral | Households continue using traditional solid fuels (e.g., coal or biomass) for cooking according to their usual practices. |
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| No ventilation during cooking | Behavioral | Households continue cooking without installing additional ventilation facilities during the intervention period. |
|
| 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Ozone (O₃) | Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand), Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Black Carbon (BC) | Unit: ug/m3, Measuring instrument: Model AE51 (AethLabs, USA), Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Systolic and Diastolic Blood Pressure | Unit: mmHg, Instrument: Omron (Japan); | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Fractional Exhaled Nitric Oxide (FeNO) | Unit: ppb , Instrument: NIOX VERO (Aerocrine AB; Solna, Sweden); | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Pulse Wave Velocity (PWV) | Assessed using an arterial stiffness analyzer (Itamar Medical, Israel) to measure arterial stiffness in meters per second (m/s). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Obesity and Central Obesity | Obesity defined as body mass index (BMI) ≥28.0 kg/m²; central obesity defined as waist circumference ≥90 cm for men or ≥85 cm for women. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Diabetes | Diagnostic criteria based on the Chinese Guidelines for the Prevention and Treatment of Type 2 Diabetes (2020). Defined as any of the following: fasting plasma glucose ≥7.0 mmol/L (confirmed by repeat testing), 2-h plasma glucose ≥11.1 mmol/L after a 75 g oral glucose tolerance test, HbA1c ≥6.5%, or random plasma glucose ≥11.1 mmol/L with typical hyperglycemic symptoms, or physician-diagnosed diabetes with initiation of glucose-lowering therapy during follow-up. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Dyslipidemia | Diagnostic criteria based on the Chinese Guidelines for the Management of Dyslipidemia in Adults (2016). Defined as any of the following without lipid-lowering therapy: total cholesterol (TC) ≥6.2 mmol/L, triglycerides (TG) ≥2.3 mmol/L, low-density lipoprotein cholesterol (LDL-C) ≥4.1 mmol/L, or high-density lipoprotein cholesterol (HDL-C) <1.0 mmol/L, or physician-diagnosed dyslipidemia with initiation of lipid-lowering treatment during follow-up. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Hypertension | Diagnostic criteria based on the Chinese Guidelines for the Prevention and Treatment of Hypertension (2024). Defined as systolic blood pressure ≥140 mmHg and/or diastolic blood pressure ≥90 mmHg measured on three separate occasions without antihypertensive treatment, or physician-diagnosed hypertension with initiation of antihypertensive therapy during follow-up. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Acute Exacerbation of Chronic Bronchitis | Measurement method: modified Anthonisen criteria. Participants with baseline chronic cough and sputum (≥3 months per year for ≥2 consecutive years) who develop acute worsening of ≥1 core symptom lasting ≥2 days (increased dyspnea, increased sputum volume, or purulent sputum) leading to activity limitation or additional medical treatment (e.g., antibiotics, oral corticosteroids, or clinical visit). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Incidence of Acute Respiratory Infection | Measurement method: weekly electronic diary (eDiary/ePRO) recording new respiratory symptoms in the past 7 days, including onset time, body temperature, and symptom spectrum. Acute respiratory infection is defined as ≥2 respiratory symptoms. For eligible cases, an "infection event form" will be initiated to record healthcare utilization, testing, and medication. A new episode is defined as recurrence after ≥7 symptom-free days. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Forced Expiratory Flow at 75% of FVC (FEF75) | Forced Expiratory Flow at 75% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Forced Expiratory Flow at 50% of FVC (FEF50) | Forced Expiratory Flow at 50% of Forced Vital Capacity measured in Liters/Second. Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Forced Expiratory Flow at 25% of FVC (FEF25) | Forced Expiratory Flow at 25% of Forced Vital Capacity measured in Liters/Second. Method of Measurement: Standardized spirometric testing | 1 year, with follow-ups at 6, 1 protocol.2, 24, and 36 months |
| Change in the Peak Expiratory Flow (PEF) | Peak Expiratory Flow measured using spirometer (HI105; Chestgraph, Japan).Units of Measure: Liters/Second. Method of Measurement: Standardized spirometric testing protocol. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Cardio-Ankle Vascular Index (CAVI) | Measured using arterial stiffness analyzer (Itamar Medical, Israel) to assess arterial stiffness. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Peripheral Arterial Tone (PAT) Index | Assessed using the EndoPAT noninvasive endothelial function detection system (Itamar Medical, Israel). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Environmental Noise Level | Unit: dB, Measuring instrument: Model ASV5910+ (Aihua Instruments Co., Ltd, China) , Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Internal Exposure to PAHs and VOCs | Unit: ng/mL, Measuring samples: Urine samples, Measurement method: GC-MS/MS. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Internal Exposure to Metal Elements | Unit: ng/mL, Measuring samples: Blood and urine samples, Measurement method: ICP-MS. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Total Volatile Organic Compounds (TVOCs) | Unit: ug/m3, Measuring instrument: Model TG-503 (GrayWolf, USA), Measurement method: Monitoring device sensors | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Nitrogen Dioxide (NO₂) | Unit: ug/m3, Measuring instrument: AEROQUAL Series 500 (Aeroqual, New Zealand) , Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of PM1 / PM10 | Unit: ug/m3, Measuring instrument: TSI NanoScan (TSI, USA), MicroPEM (PennEngineering, USA), Gillian5000 (Sensidyne, USA), Bbair (Yuanrui Environmental Protection Technology Co., Ltd, China) , Measurement method: Monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Air Temperature | Unit: °C, Measuring instrument: HOBO temperature loggers, Measurement method: monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Relative Humidity | Unit: %, Measuring instrument: HOBO humidity loggers, Measurement method: monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Wind Speed | Unit: m/s, Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Wind Direction | Unit: degrees (°), Measuring instrument: Portable ultrasonic anemometer (FT702LT/D-V22-FF, UK), Measurement method: monitoring device sensors. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Environmental Microbial Aerosols | Unit: copies/m³ or CFU/m³, Measuring instrument: Liquid-based bioaerosol samplers (BioSampler, SpinCon), Measurement method: Molecular biological detection (e.g., nucleic acid extraction and PCR-based analysis). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Serum Levels of Club Cell Protein 16 (CC16) and Surfactant Protein D (SP-D) | Lung epithelial injury will be assessed by measuring serum levels of:Club Cell Protein 16 (CC16), Surfactant Protein D (SP-D). Method: enzyme-linked immunosorbent assay (ELISA) in serum samples. Units are typically pg/mL or ng/mL, depending on assay specifications. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Serum Levels of Blood Glucose, Insulin, and C-Peptide | Method: glucose oxidase method: serum. Units (e.g., mmol/L for glucose, μIU/mL or pmol/L for insulin and C-peptide) depend on assay specifications | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Genome-wide DNA Methylation Levels in Blood Samples | Epigenetic alterations will be assessed by measuring genome-wide DNA methylation levels using peripheral blood-derived DNA. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Serum Levels of Oxidative Stress Biomarkers | Oxidative stress status will be assessed by measuring serum concentrations of the following biomarkers using ELISA assays: Angiotensin II (Ang-II) / NADPH oxidase (NOX) / Superoxide dismutase (SOD) / Glutathione (GSH) / Malondialdehyde (MDA) / Oxidized low-density lipoprotein (ox-LDL). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Serum Levels of HPA Axis Stress Hormones (Cortisol, ACTH, CRH) | The hypothalamic-pituitary-adrenal (HPA) axis function will be evaluated by measuring serum concentrations of: Cortisol / Adrenocorticotropic hormone (ACTH) / Corticotropin-releasing hormone (CRH). Measurements will be performed using enzyme-linked immunosorbent assay (ELISA). | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Triacylglycerols (TAG) | Concentrations of 40 triacylglycerols in plasma assessed using LC-MS.Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Diglycerides (DAG) | Concentrations of 4 diglycerides in plasma measured using LC-MS-based metabolomics. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Cholesteryl Esters (CE) | Concentrations of 14 cholesteryl esters in plasma determined using targeted LC-MS. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Phosphatidylethanolamines (PE) | Concentrations of 11 PE species in plasma determined using LC-MS-based metabolomics. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Lysophosphatidylethanolamines (LPE) | Concentrations of 4 LPE species in plasma assessed using LC-MS. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Sphingomyelins (SM) | Concentrations of 20 sphingomyelins in plasma measured using LC-MS-based metabolomics. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Phosphatidylcholines (PC) | Concentrations of 50 phosphatidylcholines in plasma measured using LC-MS-based targeted metabolomics. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Lysophosphatidylcholines (LPC) | Concentrations of 18 lysophosphatidylcholines in plasma determined using LC-MS metabolomic analysis. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Ceramides | Concentrations of 5 ceramides (Cer) in plasma measured by targeted LC-MS metabolomics. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Other Polar Small Molecule Metabolites in Plasma | Concentrations of 14 other polar metabolites measured in plasma using LC-MS-based targeted metabolomics. Units of Measure: μmol/L | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Carnitines and Acylcarnitines | Concentrations of 12 carnitines and acylcarnitines measured in plasma using LC-MS. Units of Measure: μmol/L | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasma Amino Acids | Concentrations of 26 amino acids measured in plasma using targeted LC-MS metabolomics. Units of Measure: μmol/L | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Tissue Plasminogen Activator (t-PA) in Serum | Concentration of t-PA in serum measured using ELISA assay. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Plasminogen Activator Inhibitor-1 (PAI-1) in Serum | Concentration of PAI-1 in serum measured using ELISA assay. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of D-dimer in Serum | Concentration of D-dimer in serum measured using ELISA assay. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Fibrinogen in Serum | Concentration of fibrinogen in serum measured using ELISA assay. Units of Measure: mg/dL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Von Willebrand Factor (vWF) in Serum | Concentration of Von Willebrand factor (vWF) measured in serum using ELISA assay. Units of Measure: μg/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentrations of Soluble CD40 Ligand (sCD40L) in Serum | Concentration of soluble CD40 ligand (sCD40L) measured in serum using ELISA assay. Units of Measure: ng/mL | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Mean Platelet Volume (MPV) (fL) | Average size of platelets measured in the blood. Units of Measure: fL. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Platelet Distribution Width (PDW) (%) | Measurement of variability in platelet size. Units of Measure: fL. Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Red Cell Distribution Width - Coefficient of Variation (RDW-CV) (%) | RDW-CV reflects relative size variability among red blood cells. Units of Measure: %. Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Red Cell Distribution Width - Standard Deviation (RDW-SD) (fL) | RDW-SD reflects variation in red cell size. Units of Measure: fL. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Platelet Count (PLT) (10⁹/L) | Platelet count measured from plasma samples. Units of Measure: 10⁹/L. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Mean Corpuscular Hemoglobin Concentration (MCHC) (g/dL) | Mean concentration of hemoglobin in red blood cells. Units of Measure: g/dL. Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Mean Corpuscular Hemoglobin (MCH) (pg/cell) | Mean corpuscular hemoglobin value measured in plasma. Units of Measure: pg (picograms). Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Mean Corpuscular Volume (MCV) (fL) | Mean corpuscular volume assessed from plasma samples. Units of Measure: fL (femtoliters). Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Hematocrit (HCT) Level (%) | Hematocrit percentage measured from plasma samples.Units of Measure: %. Method of Measurement: Clinical laboratory testing | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentration of Hemoglobin Concentration (HGB) in Plasma | Hemoglobin concentration in plasma measured in clinical laboratory. Units of Measure: g/dL. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentration of Red Blood Cells (RBC) in Plasma | Red blood cell count measured from plasma samples using automated hematology analyzer.Units of Measure: 10¹²/L. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Concentration of White Blood Cells (WBC) in Plasma | White blood cell count measured from plasma samples using automated hematology analyzer. Units of Measure: 10⁹/L. Method of Measurement: Clinical laboratory testing. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Sleep Parameters Measured by ActiGraph GT3X-BT | Objective sleep characteristics-including total sleep time, sleep efficiency, sleep latency, and wake after sleep onset-will be measured using the ActiGraph GT3X-BT wearable device. Units of Measure: Minutes for time-based parameters; percent for sleep efficiency. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Pittsburgh Sleep Quality Index (PSQI) Score | Subjective sleep quality will be assessed using the Pittsburgh Sleep Quality Index (PSQI), a validated self-reported questionnaire. Units of Measure: Points on a scale. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Serum Levels of Systemic Inflammatory Cytokines and Biomarkers | Systemic inflammation will be assessed by measuring serum concentrations of multiple cytokines and biomarkers using the MILLIPLEX multiplex assay platform. Included analytes are: C-reactive protein (CRP) / Interleukins: IL-1β, IL-5, IL-6, IL-8, IL-10, IL-12p70, IL-13, IL-17A / Macrophage-Derived Chemokine (MDC) / Tumor Necrosis Factor-alpha (TNF-α) / Interferon-gamma (IFN-γ) / Monocyte Chemoattractant Protein-1 (MCP-1). Units are typically pg/mL. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in the Expression Levels of mRNAs and miRNAs in Blood and Plasma | Transcriptomic profiling will be performed to measure the expression levels of mRNAs and microRNAs (miRNAs) in blood and plasma samples. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Cognitive Function | Assessed using the Mini-Mental State Examination (MMSE, total 30 points). Cognitive impairment is defined as MMSE <27. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Anxiety | Assessed using the Generalized Anxiety Disorder-7 (GAD-7) scale, total 7 items, maximum score 21. Severity: 0-4 none/minimal, 5-9 mild, 10-14 moderate, ≥15 severe anxiety. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Depression | Assessed using the Patient Health Questionnaire-9 (PHQ-9), total 9 items, maximum score 27. Severity: 0-4 none, 5-9 mild, 10-14 moderate, 15-19 moderately severe, 20-27 severe depression. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Retinal Microvascular Indicators | Assessed as microvascular function indicators using fundus photography. | 1 year, with follow-ups at 6, 12, 24, and 36 months |
| Change in Mucosal Immunity / Respiratory System Biomarkers | Measured using ELISA or Luminex, sample volume 200 µL. Indicators reflect respiratory system immune responses. | 1 year, with follow-ups at 6, 12, 24, and 36 months. |
| Hong'an County Health Center | Recruiting | Huanggang | Hubei | 438000 | China |
|
| Longhui County Health Center | Not yet recruiting | Shaoyang | Hunan | 422000 | China |
|
| ID | Term |
|---|---|
| D003296 | Cooking |
| ID | Term |
|---|---|
| D005511 | Food Handling |
| D019649 | Food Industry |
| D007221 | Industry |
| D013676 | Technology, Industry, and Agriculture |
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