跳至主要内容
临床试验/NCT01715844
NCT01715844已完成1 期

L-Citrulline Supplementation Pilot Study for Overweight Late Onset Asthmatics

University of Pittsburgh2 个研究点 分布在 1 个国家目标入组 10 人开始时间: 2013年9月7日最近更新:
适应症

试验速览

阶段
1 期
状态
已完成
入组人数
10
试验地点
2
主要终点
Exhaled nitric oxide

研究概览

简要总结

In people who develop asthma after the age of 12 and who are also overweigh, there can be an increased burden of asthma symptoms, more flare-ups, and poorly-controlled asthma when compared to normal weight asthmatics. Certain factors are more abundant in the blood of individuals who are obese. One such factor is derived from the metabolism of an amino acid found in your diet, which is known as L-arginine (Amino acids are most commonly known as the building blocks of proteins, the same as the proteins found in food). This factor is called asymmetric dimethylarginine or ADMA. The balance of L-arginine to ADMA may be important to the health of subjects with asthma. The balance between L-arginine and ADMA plays an important role in producing nitric oxide (NO) in the airways. NO is normally produced in the lung and plays a major role in maintaining airways open and functioning normally. Our research has shown that in subjects with asthma who are overweight and developed asthma later in life, the combination of low L-arginine and high ADMA, may lead to lower NO levels. We are asking participants in this study to take L-citrulline, which is converted to L-arginine by your body, as a supplement for a period of one week. We anticipate that L-citrulline will restore NO levels in the airways, by increasing the ratio of L-arginine to ADMA

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)

入排标准

年龄范围
18 Years 至 75 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Male and female patients, 18-75 yrs old, from all racial/ethnic backgrounds
  • Diagnosis of asthma for >1 yr
  • Baseline pre-bronchodilator FEV1 between 60 and 90% predicted with a 12% or greater bronchodilator response to 4 puffs of albuterol
  • Smoking history <20 pack years and no smoking in the last year
  • Able to identify age of asthma onset

排除标准

  • Respiratory tract infection within the last 4 weeks;
  • Oral CS burst within the last 4 weeks or regular systemic CS use
  • Hospitalization within the last 3 months
  • ER visit within the 4 weeks
  • Significant or uncontrolled concomitant medical illness including (but not limited to) heart disease, cancer, diabetes
  • Current smoking or within the previous 12 months
  • Current use of statins for the past 30 days (Statins lower ADMA levels)
  • Pregnancy
  • Intolerance or allergy to L-arginine or L-citrulline
  • Phosphodiesterase inhibitors
  • Taking oral nitrates

结局指标

主要结局

Exhaled nitric oxide

时间窗: 1 week

Patients will be randomized to 1 week of 3 g of L-citrulline/day vs matching placebo, The outcome is the pre to post intervention change in exhaled NO

次要结局

  • Sputum and plasma L-arginine/ADMA levels(1 week)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Fernando Holguin

Assistant Professor of Medicine

University of Pittsburgh

研究点 (2)

Loading locations...

相似试验