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

NCT03433963 | Completed DMC

• 1 other identifier: 2017074
• Study Type: interventional
• Target: 118
• Locations: 1 country
• Sites: 3

Brief 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.

Conditions

Blood Pressure; Cardiac Ischemia

Keywords

air pollution; blood pressure; cardiac ischemia; L-arginine; nitric oxide

Outcome Measures

Primary Outcomes (3)

• 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).

• 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)

• 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 Outcomes (8)

• 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)

• 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)

• 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)

• 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)

• 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)

Study Arms (2)

L-Arg supplement group

EXPERIMENTAL

Study participants in the group will take L-Arg supplement during the trial.

Dietary Supplement: L-Arg supplement

Control group

PLACEBO COMPARATOR

Study participants in the group will take placebo during the trial.

Dietary Supplement: Placebo

Interventions

L-Arg supplement DIETARY_SUPPLEMENT

L-Arg supplement will be prepared as pills, administered 9g each day in 3 times for 2 weeks.

L-Arg supplement group

Placebo DIETARY_SUPPLEMENT

Placebo will be prepared as pills (the same size, color and shape as of L-Arg), administered 3 times daily for 2 weeks.

Control group

Eligibility Criteria

• Age: 50 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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;
• No routine use of vasoactive dietary supplements,or, if taking, willing to forego their use during the trial.
• Fasting LDL cholesterol≥4.92 mmol/L or total cholesterol≥6.21 mmol/L or HbA1c\>9%;
• Liver or renal dysfunction;
• Acute coronary symptoms or unstable clinical manifestations within the past three months;
• Suffering from allergic diseases/known allergy to ingredients of L-Arg; or those who suffered from acute illness before start of the study;
• Alcohol or drug addiction;
• Hepatitis B / hepatitis C virus patient / carrier;
• History of organ transplants or major surgery in the past year;
• Exposed to occupational sources of air pollution;
• Unwilling or unable to provide informed consent or cooperate with all research related procedures.

Sponsors & Collaborators

• Peking University: lead

Study Sites (3)

Qinglongqiao Community Health Service Center

Beijing, 100091, China

Location

Malianwa Community Health Service Center

Beijing, 100191, China

Location

Shangdi Community Health Service Center

Beijing, 100191, China

Location

MeSH Terms

Conditions

Coronary Artery Disease

Condition Hierarchy (Ancestors)

Coronary Disease; Myocardial Ischemia; Heart Diseases; Cardiovascular Diseases; Arteriosclerosis; Arterial Occlusive Diseases; Vascular Diseases

Study Officials

• Shaowei Wu, PhD

  Peking University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor

Study Record Dates

• First Submitted: January 31, 2018
• First Posted: February 15, 2018
• Study Start: January 2, 2018
• Primary Completion: July 4, 2019
• Study Completion: March 31, 2020
• Last Updated: March 10, 2021

Record last verified: 2021-03

Data Sharing

• IPD Sharing: Will not share

Locations

CN (3)