| ID | Type | Description | Link |
|---|---|---|---|
| RFA-HL-10-003 | Other Identifier | NHLBI |
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| Name | Class |
|---|---|
| Temple University | OTHER |
| State University of New York at Buffalo | OTHER |
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Evidence from investigators' group has shown that chronic obstructive pulmonary disease (COPD) patients have impairment of antioxidant defenses which are caused by a defect in activity of Nrf2. This trial focuses on sulforaphane, a derivative of cruciferous vegetables, which is a potent stimulator of Nrf2 activity. The investigators want to investigate whether ingestion of sulforaphane by COPD patients will increase Nrf2 activity and expression of downstream antioxidants. Accordingly, the investigators are conducting a placebo-controlled randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles, for 4 weeks in 90 COPD patients. The investigators' goal is to establish a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will have a novel candidate treatment for longer-term efficacy trials.
Chronic Obstructive Pulmonary Disease (COPD) is a major cause of morbidity and mortality in the United States and is a growing cause of chronic disease internationally. Presently, there are limited treatment options for this disease to modify the progression of airflow obstruction and decrease periodic exacerbations. Recent evidence has emphasized the central role of oxidative stress as a mechanism of COPD pathobiology. Evidence from investigators' group has shown that COPD patients and animals exposed to cigarette smoke have impairment of antioxidant defenses which are caused by a defect in activity of nuclear factor erythroid 2 like 2 (Nrf2), a prolific regulator of anti-oxidant enzymes, glutathione homeostasis, and cytoprotective proteins. Activation of Nrf2 protects mice with chronic smoke exposure from developing emphysema, decreases oxidative stress, increases proteasomal anti-apoptotic cytoprotective responses, improves bacterial phagocytosis and killing, and reverses tobacco-smoke induced corticosteroid resistance. Similarly, in vitro Nrf2 activation in human COPD lung cells has shown improved cytoprotection, improved bacterial clearance, and restoration of steroid sensitivity. This trial focuses on sulforaphane, a derivative of cruciferous vegetables, which is a potent in vitro and in vivo stimulator of Nrf2 activity. The investigators want to investigate whether ingestion of sulforaphane by chronic obstructive pulmonary disease (COPD) patients will increase Nrf2 activity and expression of downstream antioxidants in alveolar macrophages and bronchial epithelial cells. Accordingly, the investigators are conducting a placebo-controlled randomized proof of principle trial of two oral doses of sulforaphane, 25 and 150 micromoles, for 4 weeks in 90 COPD patients. Collections of alveolar macrophages by Bronchoalveolar lavage (BAL), bronchial epithelial cells by endobronchial brushings will be performed at baseline and 4 weeks. Other bio-specimens will include nasal epithelial cells, Peripheral Blood Monocyte Collection (PBMCs), and expired breath condensate (EBC). The investigators' goal is to establish a safe and tolerable dose of sulforaphane that effects in vivo antioxidants via Nrf2, then the investigators will have a novel candidate treatment for longer-term efficacy trials. Ancillary studies are proposed to explore the efficacy and mechanisms of sulforaphane to increase bacterial clearance and to restore steroid sensitivity in COPD lung cells.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Sulforaphane 25 | Active Comparator | 25 micromoles (4.4 mg) sulforaphane daily by mouth |
|
| Sulforaphane 150 | Active Comparator | 150 micromoles (26.6 mg) sulforaphane daily by mouth |
|
| Placebo | Placebo Comparator | Microcrystalline cellulose |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Sulforaphane 25 | Drug | 25 micromoles (4.4 mg) sulforaphane daily by mouth |
|
| Measure | Description | Time Frame |
|---|---|---|
| Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks | The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Baseline and 4 weeks |
| Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks | The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Baseline and 4 weeks |
| Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks | The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Baseline and 4 weeks |
| Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks | The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Baseline and 4 weeks |
| Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Fold-change in Isoprostane Concentrations (Follow-up to Baseline) | Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks. | Baseline and 4 weeks |
| Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Janet T Holbrook, PhD, MPH | Johns Hopkins Bloomberg School of Public Health | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins School of Medicine | Baltimore | Maryland | 21224 | United States | ||
| University at Baffalo, The State University of New York |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31429757 | Derived | Sidhaye VK, Holbrook JT, Burke A, Sudini KR, Sethi S, Criner GJ, Fahey JW, Berenson CS, Jacobs MR, Thimmulappa R, Wise RA, Biswal S. Compartmentalization of anti-oxidant and anti-inflammatory gene expression in current and former smokers with COPD. Respir Res. 2019 Aug 20;20(1):190. doi: 10.1186/s12931-019-1164-1. | |
| 27832073 | Derived | Wise RA, Holbrook JT, Criner G, Sethi S, Rayapudi S, Sudini KR, Sugar EA, Burke A, Thimmulappa R, Singh A, Talalay P, Fahey JW, Berenson CS, Jacobs MR, Biswal S; Broccoli Sprout Extract Trial Research Group. Lack of Effect of Oral Sulforaphane Administration on Nrf2 Expression in COPD: A Randomized, Double-Blind, Placebo Controlled Trial. PLoS One. 2016 Nov 10;11(11):e0163716. doi: 10.1371/journal.pone.0163716. eCollection 2016. |
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The primary method of data-sharing will be through the traditional mechanism of publication of results in the peer-reviewed medical literature. Following publication of the main results, in accordance with NIH policy, a de-identified, HIPAA-compliant limited use dataset will be made available to qualified investigators who have Institutional Review Board approval and sign a data-use agreement. De-identified specimens collected in the study that are not analyzed for the main study will be made available to qualified investigators along with a limited use dataset in line with University and Office of Human Research Protections guidelines with a materials transfer agreement and/or data-use agreement as applicable. The Center for Clinical Trials has extensive experience in preparation of limited use datasets, and maintains policies and model agreements for data-use agreements and materials-transfer agreements.
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| ID | Title | Description |
|---|---|---|
| FG000 | Placebo | Microcrystalline cellulose Placebo: Microcrystalline cellulose once daily by mouth |
| FG001 | Sulforaphane 25 | 25 micromoles (4.4 mg) sulforaphane daily by mouth Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth |
| FG002 | Sulforaphane 150 | 150 micromoles (26.6 mg) sulforaphane daily by mouth Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
|
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| ID | Title | Description |
|---|---|---|
| BG000 | Placebo | Microcrystalline cellulose Placebo: Microcrystalline cellulose once daily by mouth |
| BG001 | Sulforaphane 25 | 25 micromoles (4.4 mg) sulforaphane daily by mouth Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Change From Baseline in Alveolar Macrophage Expression of Nrf2 and Associated Genes at 4 Weeks | The first primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in alveolar macrophages (AM) at 4 weeks by analysing Nrf2 protein and expression of a panel of Nrf2 regulated genes.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one in the 25 micromole group, and one in the 150 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
|
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Assessed via study questionnaires.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | Placebo | Microcrystalline cellulose Placebo: Microcrystalline cellulose once daily by mouth |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Cholecystitis | Hepatobiliary disorders | Systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| Nausea | Gastrointestinal disorders | Systematic Assessment |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Alexis Rea | Johns Hopkins University School of Medicine | (443) 287-8496 | area5@jhu.edu |
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| ID | Term |
|---|---|
| D029424 | Pulmonary Disease, Chronic Obstructive |
| ID | Term |
|---|---|
| D008173 | Lung Diseases, Obstructive |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D002908 | Chronic Disease |
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| Sulforaphane 150 | Dietary Supplement | 150 micromoles (26.6 mg) sulforaphane daily by mouth |
|
| Placebo | Other | Microcrystalline cellulose once daily by mouth |
|
The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. |
| Baseline and 4 weeks |
| Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks | The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Baseline and 4 weeks |
Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial. |
| Baseline and 4 weeks |
| Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group | Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage. | Baseline and 4 weeks |
| Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline) | Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL. | Baseline and 4 weeks |
| Buffalo |
| New York |
| 14215 |
| United States |
| Temple University | Philadelphia | Pennsylvania | 19122 | United States |
| BG002 | Sulforaphane 150 | 150 micromoles (26.6 mg) sulforaphane daily by mouth Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth |
| BG003 | Total | Total of all reporting groups |
| Participants |
|
| Age, Continuous | Median | Inter-Quartile Range | years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Chronic obstructive pulmonary disease (COPD) characteristics | Number | participants |
|
| Post bronchodilator FEV1 | Forced expiratory volume in 1 second (FEV1) after administration of bronchodilator | Median | Inter-Quartile Range | percent predicted |
|
| Post bronchodilator FEV1/FVC ratio | Ratio of forced expiratory volume in 1 second (FEV1) to forced vital capacity (FVC) after bronchodilation | Median | Inter-Quartile Range | ratio |
|
| Diffusing Capacity of the Lungs for Carbon Monoxide (DLCO) | DLCO: Diffusing capacity of the lungs for carbon monoxide measured by the single breath technique in accordance with American Thoracic Society standards | Median | Inter-Quartile Range | mL/mmHg/min |
|
| Pulse oximetry (SpO2) | Median | Inter-Quartile Range | Percentage of oxyhemoglobin |
|
| Pulmonary function measures | Values were determined using either helium dilution or plethysmography methods, depending on equipment available at study sites. Lung volumes were measured in accordance with local hospital procedures. | Median | Inter-Quartile Range | Liters |
|
| Use of respiratory medications in prior 2 weeks | Number | participants |
|
| Medical Research Council Dyspnea Score | Minimum score 1, maximum score 5. Higher values represent a worse outcome. | Median | Inter-Quartile Range | units on a scale |
|
| St Georges Respiratory Questionnaire | Scales, ranges, and descriptors: All scores are expressed as a percentage of overall impairment where 100 is the worst possible health status and 0 is the best possible health status. Total score (all items) summarizes the impact of the disease on overall health status Symptoms score (Q1-8) looks at the effect of respiratory symptoms, their frequency and severity. Activity score (Q11-17, 37-45) measures activities causing or limited by breathlessness Impacts score (Q18-36, 46-52) covers a range of aspects re: social functioning and psychological disturbances resulting from airways disease | Median | Inter-Quartile Range | units on a scale |
|
| OG001 | Sulforaphane 25 | 25 micromoles (4.4 mg) sulforaphane daily by mouth Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth |
| OG002 | Sulforaphane 150 | 150 micromoles (26.6 mg) sulforaphane daily by mouth Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth |
|
|
|
| Primary | Change From Baseline in Bronchial Epithelial Cell Expression of Nrf2 at 4 Weeks | The second primary design variable is the change from baseline in nuclear factor erythroid 2 like 2 (Nrf2) expression in bronchial epithelial cells (BEC) at 4 weeks by analysing Nrf2 protein. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group and one in the 25 micromole group.. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
|
|
|
|
| Primary | Change From Baseline in Bronchial Epithelial Cell Expression of NQ01 and Keap1 at 4 Weeks | The third primary design variable is the change from baseline in NAD(P)H Quinone Dehydrogenase 1 (NQ01) and Kelch Like ECH Associated Protein 1 (Keap1) expression in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and one in the 150 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
|
|
|
|
| Primary | Change From Baseline in Bronchial Epithelial Cell Expression of HO1 at 4 Weeks | The fourth primary design variable is the change from baseline in expression of Heme Oxygenase 1 (HO1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for one participant in the placebo group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
|
|
|
|
| Primary | Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C1 at 4 Weeks | The fifth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C1 (AKR1C1) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with alveolar macrophage samples in which assays could be successfully performed. Assays failed for two participants in the placebo group and two in the 150 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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|
|
| Primary | Change From Baseline in Bronchial Epithelial Cell Expression of AKR1C3 at 4 Weeks | The sixth primary design variable is the change from baseline in expression of Aldo-Keto Reductase Family 1 Member C3 (AKR1C3) in bronchial epithelial cells (BEC) at 4 weeks. Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage for primary outcome data. | Number of participants analyzed based on number of individuals with bronchial epithelial samples in which assays could be successfully performed. Assays failed for two participants in the placebo group, one participant in the 25 micromole group, and one participant in the 150 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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| Secondary | Fold-change in Isoprostane Concentrations (Follow-up to Baseline) | Isoprostane, an oxidant stress indicator, was measured in expired breath condensate at baseline and 4 weeks. | Number of participants analyzed based on number of individuals with expired breath condensate samples in which testing could be successfully performed. Samples were missing for two participants in the 25 micromole group and one participant in the 150 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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|
| Secondary | Fold-change in Serum Inflammatory Marker Concentrations (Follow-up to Baseline) | Inflammatory markers were measured in serum samples derived from venipuncture at baseline and 4 weeks in the serum of the participants of the trial. | Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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| Secondary | Fold-change in Inflammatory Marker Concentrations in Bronchial Alveolar Lavage (Follow-up to Baseline) by Treatment Group | Inflammatory markers were measured in bronchial alveolar lavage samples at baseline and 4 weeks in the participants of this trial who had bronchoalveolar lavage samples obtained.Three participants - one from each treatment group - were unable to complete follow-up bronchoalveolar lavage. | Number of participants analyzed is based on number of participants that had bronchial alveolar lavage samples available. Samples were missing for two participants in the placebo group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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| Secondary | Fold-change in Plasma Inflammatory Marker Concentrations (Follow-up to Baseline) | Inflammatory markers were measured in plasma at baseline and 4 weeks. Thiobarbituric acid reactive substances were measured in nmol malondialdehyde (MDA)/mL. | Number of participants analyzed is based on number of participants that had plasma samples available. Samples were missing for one participant in the 25 micromole group. | Posted | Median | Inter-Quartile Range | fold change | Baseline and 4 weeks |
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|
|
|
| 0 |
| 31 |
| 15 |
| 31 |
| EG001 | Sulforaphane 25 | 25 micromoles (4.4 mg) sulforaphane daily by mouth Sulforaphane 25: 25 micromoles (4.4 mg) sulforaphane daily by mouth | 2 | 29 | 21 | 29 |
| EG002 | Sulforaphane 150 | 150 micromoles (26.6 mg) sulforaphane daily by mouth Sulforaphane 150: 150 micromoles (26.6 mg) sulforaphane daily by mouth | 1 | 29 | 18 | 29 |
| COPD exacerbation | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Pneumonia | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Vomiting | Gastrointestinal disorders | Systematic Assessment |
|
| Poor appetite | Gastrointestinal disorders | Systematic Assessment |
|
| Bad taste in mouth | Gastrointestinal disorders | Systematic Assessment |
|
| Heartburn | Gastrointestinal disorders | Systematic Assessment |
|
| Headache | General disorders | Systematic Assessment |
|
| Fatigue | General disorders | Systematic Assessment |
|
| Skin rash | Skin and subcutaneous tissue disorders | Systematic Assessment |
|
| Bloating/gas | Gastrointestinal disorders | Systematic Assessment |
|
| Diarrhea | Gastrointestinal disorders | Systematic Assessment |
|
| Abdominal discomfort | Gastrointestinal disorders | Systematic Assessment |
|
| Respiratory infection | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Chest pain | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Constipation | Gastrointestinal disorders | Systematic Assessment |
|
| Increased phlegm | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
| Leg pain | Musculoskeletal and connective tissue disorders | Systematic Assessment |
|
| Shortness of breath | Respiratory, thoracic and mediastinal disorders | Systematic Assessment |
|
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| D020969 |
| Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
|
| Kruskal-Wallis |
| <0.01 |
| Superiority or Other |
|
| Interleukin-8 (pg/mL) |
|
| 0.07 |
| Superiority or Other |
| Applies to Interleukin-8 concentration | Kruskal-Wallis | 0.65 | Superiority or Other |
|
| 0.33 |
| Superiority or Other |
|
| Total antioxidants (mM Trolox equivalents/L) |
|
| 0.35 |
| Superiority or Other |
| Applies to total antioxidants results. | Kruskal-Wallis | 0.53 | Superiority or Other |