Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study

Lipids in Health and Disease

Research

Aldar S Bourinbaiar¹  Vichai Jirathitikal¹ 

[1] Immunitor USA Inc., 20740, College Park, MD, USA;

关键词: Orlistat;    High Density Lipoprotein;    Cholesteryl Ester Transfer Protein;    Rimonabant;    Sibutramine;   

DOI  :  10.1186/1476-511X-9-14

 received in 2009-12-08, accepted in 2010-02-02,  发布年份 2010

来源: Springer

【 摘 要 】

BackgroundChronic inflammations, atherosclerosis and obesity, are major risk factors for cardiovascular diseases. Immune modulation of the inflammatory response has shown promise in animal models of atherogenesis and metabolic disease. Tableted dietary supplement, V-6, containing pooled antigens derived from pig adipose tissue has been administered daily to 12 volunteers for 2 months.ResultsNo significant changes were observed in liver ALT and AST enzymes, i.e., 28 vs 23.8 IU and 22.6 vs 24.8 IU, with p = 0.07 and p = 0.49, respectively. Creatinine decreased; 0.88 vs 0.84 mg/dL (p = 0.05) while BUN moved upward; 14.5 vs 17.5 mg/dL (p = 0.01), but both values remained within normal range. Blood glucose remained within normal range; 96.1 vs 101.1 mg/dL (p = 0.04). Complete blood cell analysis has not revealed any change except slight increase in hemoglobin; 13.13 to 13.96 g/dL (p = 0.0002); hematocrit and red blood cells count 40.3 to 42.3% (p = 0.02) and 5.15 to 5.35 × 106 cells/mm3 (p = 0.03) respectively. Blood pressure systolic and diastolic values were not affected, i.e., 116.1 vs 116.3 (p = 0.12) and 76.8 vs 76.6 (p = 0.99). Body weight and body mass index (BMI) remained same; 66.4 vs 66.3 kg (p = 0.47) and 25.7 vs 25.6 kg/m2 (p = 0.2). Body fat deposit indices, such as abdomen; mid-arm; and thigh circumferences declined by 3.5 cm (p = 0.008); 1.2 cm (p = 0.004); and 3.0 cm (p = 0.0007) respectively. The total cholesterol and LDL levels did not change; 195.5 vs 195.1 (-0.2%; p = 0.8) and 113.4 vs 120.3 (6.1%; p = 0.08) respectively. Triglycerides have been reduced but not statistically significant; 168.1 vs 118 mg/dL (-29.8%; p = 0.2). In contrast, HDL content had risen by 29.7% from 39.4 to 51.1 mg/dL in all 12 patients (p = 0.000003). TG/HDL ratio - a marker of insulin resistance - was reduced from 4.78 to 2.56 (-46.5%; p = 0.04).ConclusionsThese results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.

【 授权许可】

CC BY   
© Bourinbaiar and Jirathitikal; licensee BioMed Central Ltd. 2010