BACKGROUND: To test alternative medicine approaches with a specifically designed Tibetan dietary and behavioral program in patients with established coronary artery disease (CAD) and manifest metabolic syndrome.METHODS: This was a randomized, controlled, double-blinded, parallel group dietary and behavioral intervention study. Between December 2008 and November 2010, patients were randomly adjudicated either to evidence-based Western diet (usual care), or to Tibetan diet. We evaluated 524 patients undergoing coronary angiography. All patients were white Caucasian, presented with a body mass index (BMI) >25 kg/m(2), and had evidence of metabolic syndrome. The primary endpoint was change in body weight and BMI at 6 months follow-up. Secondary endpoints included blood pressure, heart rate, intima media thickness, lipids, fasting glucose, glycated hemoglobin, fibrinogen, C-reactive protein (CRP) at 6 months follow-up and change in body weight and BMI at 12 months. RESULTS: Both groups of patients showed significantly reduced body weight and BMI compared to baseline (6 months, usual care weight change: -3.2 ± 3.0 kg; BMI change: -1.1 ± 1.0 kg/m(2); Tibetan diet weight change: -6.2 ± 4.4 kg/m(2); BMI change: -2.1 ± 1.5 kg/m(2)), but these changes were more pronounced in Tibetan diet compared to usual care (all, p<0.001). Beneficial effects on weight and BMI were maintained after 12 months of follow-up (p<0.0001). Levels of total and LDL cholesterols, fibrinogen and CRP were decreased in both groups, but more pronounced in Tibetan diet (Tibetan diet vs. usual care (total cholesterol): 176.2 ± 43.7 vs. 185.1 ± 47.8 mg/dL; p=0.024; LDL: 111.6 ± 37.8 vs. 119.4 ± 40.9 mg/dL; p=0.026; fibrinogen: 318.3 ± 90.4 vs. 334.1 ± 87.9 mg/dL; p=0.040; CRP: 1.2 ± 3.0 vs. 2.2 ± 4.5mg/dL; p=0.036). CONCLUSIONS: Tibetan diet reduces body weight and BMI in patients with CAD and metabolic syndrome after 6 months significantly better than Western diet and may induce lipid-modifying and anti-inflammatory effects (ClinicalTrials.gov identifier: NCT00810992).