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

Aldar S Bourinbaiar, Vichai Jirathitikal, Aldar S Bourinbaiar, Vichai Jirathitikal

Abstract

Background: Chronic 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.

Results: No 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 5.35x10(6) 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).

Conclusions: These results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.

Figures

Figure 1
Figure 1
Changes in total plasma cholesterol (CH; -0.2%; p = 0.76), low density lipoproteins (LDL; +6.1%; p = 0.08), triglycerides (TG; -29.8%; p = 0.24), and high density lipoproteins (HDL; +29.7%; p = 0.000003), resulting from oral administration of V-6 as evaluated by repeated measure ANOVA. Individual values from each of 12 patients, collected through weeks 2, 4, and 8, are plotted and mean values are shown in each graph in bold.
Figure 2
Figure 2
Negligible effect of daily dose of V-6 on body mass index (BMI; -0.4%; p = 0.21) as opposed to statistically significant reduction in waist (-3.8%; p = 0.008), mid-arm (-3.9%; p = 0.004), and thigh (-5.3%; p = 0.0007) circumferences as followed through weeks 2, 4, and 8. Individual values from each time-point for every patient are plotted and mean values are shown as bold line.

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