Blood Pressure Clinical Trial
Official title:
The Use of L-arginine to Mitigate the Cardiovascular Effects of Exposure to Traffic-related Air Pollution: A Randomized, Double-blind, Placebo-controlled Trial
NCT number | NCT03433963 |
Other study ID # | 2017074 |
Secondary ID | |
Status | Completed |
Phase | N/A |
First received | |
Last updated | |
Start date | January 2, 2018 |
Est. completion date | March 31, 2020 |
Verified date | March 2021 |
Source | Peking University |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
The present study is aimed to investigate whether oral L-arginine supplementation reduces the adverse cardiovascular effects of exposure to traffic-related air pollution among a group of non-smoking adults with elevated blood pressure.
Status | Completed |
Enrollment | 118 |
Est. completion date | March 31, 2020 |
Est. primary completion date | July 4, 2019 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 50 Years to 75 Years |
Eligibility | Inclusion Criteria: 1. Having elevated systolic blood pressure between 120-160 mmHg, and diastolic blood pressure between 65-100 mmHg, either with or without routine antihypertensive medications. 2. Adults between 50 and 75 years of age, current non-smokers; 3. Do not take routine vasoactive dietary supplements. Exclusion Criteria: 1. Hypertension with SBP>160 mmHg or DBP>100 mmHg, clinical diagnosis of cardiovascular disease (excluding hypertension), or other important chronic diseases such as coagulopathy, chronic obstructive pulmonary disease, asthma, gastrointestinal diseases, cancer or mental diseases; 2. No routine use of vasoactive dietary supplements,or, if taking, willing to forego their use during the trial. 3. Fasting LDL cholesterol=4.92 mmol/L or total cholesterol=6.21 mmol/L or HbA1c>9%; 4. Liver or renal dysfunction; 5. Acute coronary symptoms or unstable clinical manifestations within the past three months; 6. Suffering from allergic diseases/known allergy to ingredients of L-Arg; or those who suffered from acute illness before start of the study; 7. Alcohol or drug addiction; 8. Hepatitis B / hepatitis C virus patient / carrier; 9. History of organ transplants or major surgery in the past year; 10. Exposed to occupational sources of air pollution; 11. Unwilling or unable to provide informed consent or cooperate with all research related procedures. |
Country | Name | City | State |
---|---|---|---|
China | Malianwa Community Health Service Center | Beijing | |
China | Qinglongqiao Community Health Service Center | Beijing | |
China | Shangdi Community Health Service Center | Beijing |
Lead Sponsor | Collaborator |
---|---|
Peking University |
China,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Change in systolic and diastolic blood pressure from before the dietary intervention to before, during, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before and during the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22h after the exposure scenario (15th day). | ||
Primary | Change in ST-segment depression from before the dietary intervention to before, during until 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); and 24 hours from the start of 2-h exposure scenario (14th day) until 22h after the exposure scenario (15th day) | ||
Primary | Change in ambulatory blood pressure during the 2-h exposure scenario (vs. before the dietary intervention) | during the 2-h exposure scenario (14th day) | ||
Secondary | Change in plasma L-Arg from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in plasma nitric oxide (including nitrate and nitrite) from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in plasma cyclic guanosine monophosphate from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in plasma C-reactive protein from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in plasma myeloperoxidase from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in pulse oxygen saturation from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in endothelial nitric oxide synthase from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) | ||
Secondary | Change in two related amino acids (citrulline and ornithine) in L-arg metabolic pathway from before the dietary intervention to before, 30min after and 22h after the 2-h exposure scenario | before taking L-Arg supplement/placebo (1st day); before the 2-h exposure scenario (14th day); 30min after the exposure scenario (14th day); and 22 hours after the exposure scenario (15th day) |
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