Trial reportLipids in health and disease2010
Safety and efficacy trial of adipose-tissue derived oral preparation V-6 Immunitor (V-6): results of open-label, two-month, follow-up study.
Trial report in Lipids in health and disease, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT03042741 (Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis), which is not on this map. Cited by 5 papers.
What it found
Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.
The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
Phase II Trial of Daily Dose of Oral Vaccine Against Atherosclerosis
Who cites it
5 citing papers in PubMed, 8 citations in OpenAlex.
- Review
- Targeting aging and age-related diseases with vaccines.Nature aging · 2024Review
- Atherosclerosis antigens as targets for immunotherapy.Nature cardiovascular research · 2023Review
- Two decades of vaccine development against atherosclerosis.Nano today · 2023Article
- Review
Corrections and comments
PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.
Authors and funding
2 authors at 1 institution in 1 country.
Funding
No grant is acknowledged in the PubMed record.
Abstract
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 5.35x10(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).
conclusionsThese results demonstrate that V-6 is safe and has a potential as an anti-atherogenic and overweight/obesity immune intervention.
Indexed as
Identifiers
What OpenQuestion holds
Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.