The Use of L-arginine to Mitigate the Cardiovascular Effects of Exposure to Traffic-related Air Pollution

Last updated: March 8, 2021
Sponsor: Peking University
Overall Status: Completed

Phase

N/A

Condition

Vascular Diseases

Hypercholesterolemia

Atherosclerosis

Treatment

N/A

Clinical Study ID

NCT03433963
2017074
  • Ages 50-75
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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.

Eligibility Criteria

Inclusion

Inclusion Criteria:

  1. Having elevated systolic blood pressure between 120-160 mmHg, and diastolic bloodpressure between 65-100 mmHg, either with or without routine antihypertensivemedications.
  2. Adults between 50 and 75 years of age, current non-smokers;
  3. Do not take routine vasoactive dietary supplements.

Exclusion

Exclusion Criteria:

  1. Hypertension with SBP>160 mmHg or DBP>100 mmHg, clinical diagnosis of cardiovasculardisease (excluding hypertension), or other important chronic diseases such ascoagulopathy, chronic obstructive pulmonary disease, asthma, gastrointestinaldiseases, cancer or mental diseases;
  2. No routine use of vasoactive dietary supplements,or, if taking, willing to foregotheir 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 threemonths;
  6. Suffering from allergic diseases/known allergy to ingredients of L-Arg; or those whosuffered 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 relatedprocedures.

Study Design

Total Participants: 118
Study Start date:
January 02, 2018
Estimated Completion Date:
March 31, 2020

Study Description

The present study is designed as a randomized, double-blind, placebo-controlled trial of L-arginine (L-Arg, a precursor of nitric oxide in human body) supplement to counteract the acute cardiovascular effects of exposure to traffic-related air pollution among a group of non-smoking adults with elevated blood pressure. A large number of epidemiological studies have provided compelling evidence that exposure to traffic-related air pollution contributes to the increases in cardiovascular morbidity and mortality, and the mechanism of action includes vasoconstriction and cardiac ischemia. It is well known that nutritional factors are very important determinants of cardiovascular health. However, few studies have explored the joint effects of air pollution and nutritional factors on cardiovascular health. Existing data from many laboratory studies and small clinical trials suggest that L-Arg has beneficial effects on the cardiovascular system by lowering blood pressure and protecting myocardiocytes against external stimuli. The study will explore whether L-Arg supplement improves blood pressure levels and prevents potential cardiac ischemia upon acute exposure to traffic-related air pollution among high-risk individuals.

Dietary intakes, lifestyle habits, use of medication/dietary supplements, blood pressure, resting electrocardiogram and plasma parameters were assessed for potential eligible participants at screening visits. Over 500 participants completed the screening visits, and 118 of them were eligible after a 5-day L-Arg-free run-in period and willing to participate in the following intervention. Eligible participants were assigned to either the interventional group or control group using a computerized method with a randomized block design. They received 2 weeks (may float back and forth for 1-3 days due to scheduling issues) daily doses of either L-Arg (9g/day in 3 times) or placebo and undergo a 2-h exposure scenario (0900-1100 hours) of walking along a traffic road on the 14th day. Participants were counseled to maintain an isocaloric diet and to abstain from other L-Arg rich foods during the study. Concentrations of major traffic-related air pollutants, including particulate matter with an aerodynamic diameter ≤ 2.5 μm (PM2.5), black carbon, and nitrogen dioxide, were measured from the beginning of the 2-h exposure scenario to 22h after exposure or during the 2-h exposure scenario, and primary and secondary outcome measures including blood pressure, ST-segment depression and plasma parameters were assessed repeatedly at various time points (depending on the parameters) around the 2-h exposure scenario. Other environmental factors, including noise, temperature and relative humidity, were also recorded during the 2-h exposure scenario and up to 22h after exposure.

Connect with a study center

  • Malianwa Community Health Service Center

    Beijing, 100191
    China

    Site Not Available

  • Qinglongqiao Community Health Service Center

    Beijing, 100091
    China

    Site Not Available

  • Shangdi Community Health Service Center

    Beijing, 100191
    China

    Site Not Available

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