L-Citrulline in Peripheral Artery Disease
关键词
抽象
描述
The primary aim of this trial is to examine whether the oral food supplement L-citrulline has any effect on clinical status, walking distance, arterial and endothelial function in participants with PAD.
The investigators will use a double-blinded crossover design in which patients serve as their own controls. Patients who are enrolled will have two 'treatment' periods of twelve weeks with a wash-out period of 4 weeks in between. Patients will be randomly assigned to get L-citrulline in the first and placebo in the second period and vice versa.
After a screening phase of 3 weeks, there will be a 'zero-point' measurement en then the first 'treatment' period of 12 weeks starts (placebo or food-supplement). Then there is a wash-out phase of 4 weeks after which the second 'treatment' period starts (food-supplement or placebo) In both periods, after 2 weeks and at the end of the period, a measurement of primary and secondary outcomes will be done: a questionnaire has to be filled out, treadmill test and flow-mediated dilation (for vessel function). The follow-up will take another 4 weeks and will end with a phone call to check for the condition of the patient and possible side effects.
Since every patient gets both placebo and the food-supplement, every patient is his/her own control.
The study was completed with 24 patients in Hannover, Germany, and 25 in Melbourne, Australia.
日期
| 最后验证: | 08/31/2019 |
| 首次提交: | 08/09/2015 |
| 提交的预估入学人数: | 08/11/2015 |
| 首次发布: | 08/12/2015 |
| 上次提交的更新: | 09/16/2019 |
| 最近更新发布: | 09/18/2019 |
| 实际学习开始日期: | 07/31/2016 |
| 预计主要完成日期: | 02/19/2019 |
| 预计完成日期: | 08/29/2019 |
状况或疾病
干预/治疗
Dietary Supplement: L-citrulline
Dietary Supplement: Maltodextrin
相
手臂组
| 臂 | 干预/治疗 |
|---|---|
| Experimental: L-citrulline Oral food-supplemental amino-acid L-citrulline. 2 times 3g per day. | Dietary Supplement: L-citrulline L-citrulline 2 times daily 3 gram (6g/day) |
| Placebo Comparator: Maltodextrin Maltodextrin as placebo. 2 times 3g per day | Dietary Supplement: Maltodextrin Maltodextrin 2 times daily 3 gram (6g/day) |
资格标准
| 有资格学习的年龄 | 40 Years 至 40 Years |
| 有资格学习的性别 | All |
| 接受健康志愿者 | 是 |
| 标准 | Inclusion Criteria: - 40 years or older males and postmenopausal women; - male participants must agree to using an adequate form of contraception during the study period; - 6-month history of stable intermittent claudication (IC) due to PAD; - PAD secondary to atherosclerosis with significant claudication (Fontaine class II defined as IC, or Fontaine class III defined as pain at rest); - IC characterised by pain, ache, cramp, numbness or severe fatigue involving muscles of one or both lower extremities, reproducibly provoked by walking and relieved by rest; - ankle-brachial index (ABI) at rest of <0.9 and at least 25% decrease in ABI within 1 min during exercise recovery; - capacity to walk more than 2 min/15 meters but no more than 12 min on a treadmill using the Skinner-Gardner protocol; - walking limited by claudication, not coexisting conditions; and - difference between two consecutive baseline exercise treadmill tests of <25% during the 3-weeks run-in period; and - no change in medications or physical activity within 3 months prior to enrolment. Exclusion Criteria: - Women of child-bearing potential; - Current enrolment in another clinical trial and/or ingestion of another investigational product within the past 30 days before enrolment; - PAD of non-atherosclerotic nature; - Fontaine class IV i.e. ulcer or gangrene; - leg amputation above the ankle; - peripheral vascular surgery, sympathectomy, peripheral angioplasty or stent insertion within the previous 3 months; - myocardial infarction, unstable angina, percutaneous transluminal coronary angioplasty or coronary artery bypass graft surgery within the previous 3 months; - uncontrolled hypertension (resting systolic blood pressure (SBP) >190 or diastolic blood pressure (DBP) >115 mmHg); - hypotension (SBP <90mmHg); - type I diabetes, proliferative retinopathy; - history of disease state or surgery that affects gastrointestinal absorption; - significant renal disease (serum creatinine >3.0 mg/dl); - liver disease (transaminase > 3x upper limit of normal, bilirubin >1.5 times upper limits of normal); - history of treatment for any malignancy within the past 5 years, or evidence of active malignancy other than squamous cells or basal cell carcinoma of the skin; - serious infection or hypotension associated with sepsis in the last month; - cerebrovascular infarct in the last 3 months; - autoimmune disorders (e.g. systemic lupus erythematosis, ulcerative colitis); - any other acute or chronic medical condition that in the opinion of the investigators increases the likelihood that the participant would be unable to complete the study; - unwillingness to discontinue arginine- or L-citrulline-containing products, pentoxifylline, L-carnitine, or prostacyclin for at least 1 month prior to and during the study; and - conditions other than PAD that limit walking distance. |
结果
主要结果指标
1. Absolute claudication distance [30 weeks]
次要成果指标
1. Endothelial function using endo-PAT (peripheral arterial tone) [30 weeks]
其他成果措施
1. L-citrulline metabolites [30 weeks]
2. Walking impairment questionnaire [30 weeks]
