Nutritional therapy for peripheral arterial disease: a double-blind, placebo-controlled, randomized trial of HeartBar (R)

We investigated the clinical effects of a food bar enriched with L-arginine and a combination of other nutrients known to enhance the activity of endo thelium-derived nitric oxide (EDNO) in individuals with claudication from a therosclerotic peripheral arterial disease. The study was a 2-week, double- blind, placebo-controlled trial of subjects randomized to three groups (two active bars, one active and one placebo bar, and two placebo bars per day) followed by an 8-week open-label period. Subjects (n = 41) were outpatient volunteers with intermittent claudication. Pain-free and total walking dis tances were measured by variable-grade, treadmill exercise testing. Quality of life was assessed using the Medical Outcome Survey (SF-36). After 2 wee ks of treatment, the pain-free walking distance increased 66% while the tot al walking distance increased 23% in the group taking two active bars/day. The general and emotional/social functioning components of the SF-36 also i mproved. These effects were not observed in the one active bar/day and plac ebo groups. The effects were maintained after 10 weeks and, in addition, an improvement in walking distance was observed in the group taking one activ e bar. These findings reveal that use of a nutrient bar designed to enhance EDNO activity improves pain-free and total walking distance as well as qua lity of life in individuals with intermittent claudication.