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

Bourinbaiar AS, Jirathitikal V - Lipids Health Dis (2010)

Bottom Line: 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).TG/HDL ratio--a marker of insulin resistance--was reduced from 4.78 to 2.56 (-46.5%; p=0.04).

View Article: PubMed Central - HTML - PubMed

Affiliation: Immunitor USA Inc, College Park, MD 20740, USA. immunitor@aol.com

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.

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Related in: MedlinePlus

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.
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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.

Mentions: None of the patients had reported any adverse effect attributed to V-6 treatment, most had noted better mood and quality of life. While subjective, these impressions are corroborated by objective lab analysis results. The serum levels of lipids such as total cholesterol, LDL, HDL and triglycerides have been analyzed at 2 week, 1 month and 2 month intervals after first administered dose of V-6 (Fig. 1). The total cholesterol content has not changed from the baseline value; 195.5 vs 195.1 (p = 0.76). LDL levels fluctuated slightly upward but results were not statistically significant, i.e., 113.4 vs 120.3 (p = 0.08). The cholesterol to LDL ratio has not changed considerably, i.e., 1.86 vs 1.66 (p = 0.17). In contrast, levels of HDL have increased by 29.7% from 39.4 to 51.1 mg/dL (p = 0.000003) in all 12 patients. The average/median increase in HDL at the end of 2 months treatment was equal to 11.7/11 mg/dL (range 5-21 mg/dL; 95% CI 8.7 - 14.6 mg/dL). This change reflected in decrease of cholesterol to HDL ratio by 25% from 5.17 to 3.88 (p = 0.000001). TG levels were reduced in 8 out 12 patients with average intra-group decrease equal to 29.8%, i.e., from 168.1 to 118 mg/dL (p = 0.24). Nevertheless, this change was not statistically significant despite the fact that average TG decrease (-51.9%) among 8 responders has been substantial (-80.9 mg/dL; 95% CI 150.1-11.7) as opposed to modest increase (+6.8%) in non-responders (+11.5 mg/dL; 95% CI 8.4-31.4). This incongruity is likely to be due to high outlier TG values, especially in patient #4, which caused skewed and statistically non-significant results. The removal of patient #4 outlier numbers produced mean 25.4% decrease, i.e., from 124.9 to 93.2 mg/dL and improved the probability value (p = 0.1), but it remained insignificant. The use of repeated measure, non-parametric Friedman test has not produced better significance as obtained p value (0.23) was still above significance level. Paired, two-tailed Student t-test, which compared baseline and end-of-study outcomes of all 12 patients produced p = 0.054, which was still above 0.05 cut-off value. The quasi-linear regression analysis that considers the gap between baseline and end-of-study TG values from outliers (patients #4 and #6) and remaining patients produced p = 0.000000004 with R-squared regression coefficient 0.89. These results indicate that there is a significant trend supporting TG decrease but sample size has been insufficient to make definitive conclusion. The TG/HDL ratio, which is a predictor of insulin resistance and CHD risk, has been reduced by almost half (46.5%; p = 0.036) from mean 4.78 (95% CI 1.11-8.45) to 2.56 (95% CI 0.86-4.26) as evaluated by paired Student t-test.


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

Bourinbaiar AS, Jirathitikal V - Lipids Health Dis (2010)

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.
© Copyright Policy - open-access
Related In: Results  -  Collection

License
Show All Figures
getmorefigures.php?uid=PMC2823747&req=5

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.
Mentions: None of the patients had reported any adverse effect attributed to V-6 treatment, most had noted better mood and quality of life. While subjective, these impressions are corroborated by objective lab analysis results. The serum levels of lipids such as total cholesterol, LDL, HDL and triglycerides have been analyzed at 2 week, 1 month and 2 month intervals after first administered dose of V-6 (Fig. 1). The total cholesterol content has not changed from the baseline value; 195.5 vs 195.1 (p = 0.76). LDL levels fluctuated slightly upward but results were not statistically significant, i.e., 113.4 vs 120.3 (p = 0.08). The cholesterol to LDL ratio has not changed considerably, i.e., 1.86 vs 1.66 (p = 0.17). In contrast, levels of HDL have increased by 29.7% from 39.4 to 51.1 mg/dL (p = 0.000003) in all 12 patients. The average/median increase in HDL at the end of 2 months treatment was equal to 11.7/11 mg/dL (range 5-21 mg/dL; 95% CI 8.7 - 14.6 mg/dL). This change reflected in decrease of cholesterol to HDL ratio by 25% from 5.17 to 3.88 (p = 0.000001). TG levels were reduced in 8 out 12 patients with average intra-group decrease equal to 29.8%, i.e., from 168.1 to 118 mg/dL (p = 0.24). Nevertheless, this change was not statistically significant despite the fact that average TG decrease (-51.9%) among 8 responders has been substantial (-80.9 mg/dL; 95% CI 150.1-11.7) as opposed to modest increase (+6.8%) in non-responders (+11.5 mg/dL; 95% CI 8.4-31.4). This incongruity is likely to be due to high outlier TG values, especially in patient #4, which caused skewed and statistically non-significant results. The removal of patient #4 outlier numbers produced mean 25.4% decrease, i.e., from 124.9 to 93.2 mg/dL and improved the probability value (p = 0.1), but it remained insignificant. The use of repeated measure, non-parametric Friedman test has not produced better significance as obtained p value (0.23) was still above significance level. Paired, two-tailed Student t-test, which compared baseline and end-of-study outcomes of all 12 patients produced p = 0.054, which was still above 0.05 cut-off value. The quasi-linear regression analysis that considers the gap between baseline and end-of-study TG values from outliers (patients #4 and #6) and remaining patients produced p = 0.000000004 with R-squared regression coefficient 0.89. These results indicate that there is a significant trend supporting TG decrease but sample size has been insufficient to make definitive conclusion. The TG/HDL ratio, which is a predictor of insulin resistance and CHD risk, has been reduced by almost half (46.5%; p = 0.036) from mean 4.78 (95% CI 1.11-8.45) to 2.56 (95% CI 0.86-4.26) as evaluated by paired Student t-test.

Bottom Line: 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).TG/HDL ratio--a marker of insulin resistance--was reduced from 4.78 to 2.56 (-46.5%; p=0.04).

View Article: PubMed Central - HTML - PubMed

Affiliation: Immunitor USA Inc, College Park, MD 20740, USA. immunitor@aol.com

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.

Show MeSH
Related in: MedlinePlus