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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

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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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.

Mentions: V-6 effect was measured for changes in body weight and body mass index (BMI). No significant alterations in body weight were found, with average weight prior to and after treatment being 66.37 vs 66.28 kg (p = 0.47). Similar, non-significant decrease was observed with BMI, i.e., 25.7 vs 25.6 kg/m2 (p = 0.21) (Fig. 2). The anthropometric predictors of body fat such as abdomen, mid-arm, and thigh circumferences were evaluated by repeated measure ANOVA (Fig. 2). Waistline decreased in 8 out 12 individuals from average 91.54 to 88.08 cm (3.5 cm; p = 0.008; 95% CI 8.9-2.0 cm). The waist circumference, when stratified to 9 women, declined from abdominal obesity defining level 88.7 cm down to 84.1 cm (4.6 cm; p = 0.001; 95% CI 2.9-12.1 cm). Mid-arm circumference had decreased by 4% in 8 out 12 individuals from average 30.9 cm to 29.7 cm at the end of two months (1.2 cm; p = 0.0035; 95% CI 0.14-2.6 cm). The thigh circumference has been reduced in 10 out of 12 individuals, i.e., 56.17 at baseline vs 53.2 cm (2.96 cm; p = 0.0007; 95% CI 0.8-5.1 cm). The similarity in outcome from all three measured sites of fat deposition indicates that this trend is consistent and statistically significant despite small sample size.


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)

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

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

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.
Mentions: V-6 effect was measured for changes in body weight and body mass index (BMI). No significant alterations in body weight were found, with average weight prior to and after treatment being 66.37 vs 66.28 kg (p = 0.47). Similar, non-significant decrease was observed with BMI, i.e., 25.7 vs 25.6 kg/m2 (p = 0.21) (Fig. 2). The anthropometric predictors of body fat such as abdomen, mid-arm, and thigh circumferences were evaluated by repeated measure ANOVA (Fig. 2). Waistline decreased in 8 out 12 individuals from average 91.54 to 88.08 cm (3.5 cm; p = 0.008; 95% CI 8.9-2.0 cm). The waist circumference, when stratified to 9 women, declined from abdominal obesity defining level 88.7 cm down to 84.1 cm (4.6 cm; p = 0.001; 95% CI 2.9-12.1 cm). Mid-arm circumference had decreased by 4% in 8 out 12 individuals from average 30.9 cm to 29.7 cm at the end of two months (1.2 cm; p = 0.0035; 95% CI 0.14-2.6 cm). The thigh circumference has been reduced in 10 out of 12 individuals, i.e., 56.17 at baseline vs 53.2 cm (2.96 cm; p = 0.0007; 95% CI 0.8-5.1 cm). The similarity in outcome from all three measured sites of fat deposition indicates that this trend is consistent and statistically significant despite small sample size.

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