Beneficial effects of the amino-acid food supplement L-Citrulline in Participants with Peripheral artery disease

Completed

• Conditions: peripheral artery disease; 10003216

• Registration Number: NL-OMON43867
• Lead Sponsor: niversiteit Maastricht

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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 SBP >190 or 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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>The primary efficacy parameter is the change in absolute claudication distance<br /><br>(measured as treadmill-measured maximum walking distance) in the randomized<br /><br>groups. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p> The secondary efficacy parameters include arterial and endothelial functions<br /><br>and measurements of the metabolites of L-citrulline metabolism. </p><br>