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Abstract Background Recent evidence suggests that certain fetal anomalies detected upon prenatal ultrasound screenings are associated with autism spectrum disorder (ASD). In this cross-sectional study, we aimed to identify genetic variants associated with fetal ultrasound anomalies (UFAs) in children with ASD. Methods The study included all children with ASD who are registered in the database of the Azrieli National Center of Autism and Neurodevelopment and for whom both prenatal ultrasound and whole exome sequencing (WES) data were available. We applied our in-house integrative bioinformatics pipeline, AutScore, to these WES data to prioritize rare, gene-disrupting variants (GDVs) probably contributing to ASD susceptibily. Univariate statistics and multivariable regression were used to assess the associations between UFAs and GDVs identified in these children. Results The study sample comprised 126 children, of whom 43 (34.1%) had at least one UFA detected in the prenatal ultrasound scan. A total of 87 candidate ASD genetic variants were detected in 60 children, with 24 (40%) children carrying multiple variants. Children with UFAs were more likely to have loss-of-function (LoF) mutations (aOR = 2.55, 95%CI: 1.13–5.80). This association was particularly noticeable when children with structural anomalies or children with UFAs in their head and brain scans were compared to children without UFAs (any mutation: aOR = 8.28, 95%CI: 2.29–30.01; LoF: aOR = 5.72, 95%CI: 2.08–15.71 and any mutation: aOR = 6.39, 95%CI: 1.34–30.47; LoF: aOR = 4.50, 95%CI: 1.32–15.35, respectively). GDVs associated with UFAs were enriched in genes highly expressed across all tissues (aOR = 2.76, 95%CI: 1.14–6.68). There was a weak, but significant, correlation between the number of mutations and the number of abnormalities detected in the same children (r = 0.21, P = 0.016). Conclusions The results provide valuable insights into the potential genetic basis of prenatal organogenesis abnormalities associated with ASD and shed light on the complex interplay between genetic factors and fetal development.

Abstract Background Flight attendants face various risk factors in their working environments, particularly occupational exposure to cosmic radiation. This study aimed to assess cancer risk among air transportation industry workers, including flight attendants, in Korea by constructing a cohort using national health registry-based data and analyzing cancer incidence risk. Methods We used the Korea National Health Insurance Service database from 2002 to 2021 to construct a cohort of 37,011 workers in the air transportation industry. Cancer incidence was defined using the tenth version of the International Classification of Diseases. We calculated the age- and sex-specific standardized incidence ratios (SIRs) and 95% confidence intervals (CIs) by applying the cancer incidence rate of the general population between 2002 and 2019. Results Approximately 5% of the cohort developed cancer. Overall, the cancer incidence in the cohort was similar to or lower than that of the general population, with the SIRs for all cancers being lower. However, significantly higher SIRs were observed for nasopharyngeal cancer (SIR, 3.21; 95% CI, 1.71–5.48) and non-Hodgkin lymphoma (SIR, 1.57; 95% CI, 1.02–2.32) in male workers and breast and genital cancer (SIR, 1.51; 95% CI, 1.34–1.70) and thyroid cancer (SIR, 1.25; 95% CI, 1.05–1.47) in female workers. Conclusions The lower overall cancer incidence among air transportation industry workers observed in this study could indicate the “healthy worker effect”; however, the incidences of certain cancers were higher than those in the general population. Given that these workers are exposed to multiple occupational and lifestyle-related risk factors, including cosmic radiation, further studies are necessary to determine radiation-induced cancer risk while considering potential confounding factors.

Abstract Background Conducting genome-wide association studies (GWAS) for reproductive traits in Hanwoo cattle, including age at first calving (AFC), calving interval (CI), gestation length (GL), and number of artificial inseminations per conception (NAIPC), is of paramount significance. These analyses provided a thorough exploration of the genetic basis of these traits, facilitating the identification of key markers for targeted trait improvement. Breeders can optimize their selection strategies, leading to more efficient and sustainable breeding programs, by incorporating genetic insights. This impact extends beyond individual traits and contributes to the overall productivity and profitability of the Hanwoo beef cattle industry. Ultimately, GWAS is essential in ensuring the long-term genetic resilience and adaptability of Hanwoo cattle populations. The primary goal of this study was to identify significant single nucleotide polymorphisms (SNPs) or quantitative trait loci (QTLs) associated with the studied reproductive traits and subsequently map the underlying genes that hold promise for trait improvement. Results A genome-wide association study of reproductive traits identified 68 significant single nucleotide polymorphisms (SNPs) distributed across 29 Bos taurus autosomes (BTA). Among them, BTA14 exhibited the highest number of identified SNPs (25), whereas BTA6, BTA7, BTA8, BTA10, BTA13, BTA17, and BTA20 exhibited 8, 5, 5, 3, 8, 2, and 12 significant SNPs, respectively. Annotation of candidate genes within a 500 kb region surrounding the significant SNPs led to the identification of ten candidate genes relevant to age at first calving. These genes were: FANCG, UNC13B, TESK1, TLN1, and CREB3 on BTA8; FAM110B, UBXN2B, SDCBP, and TOX on BTA14; and MAP3K1 on BTA20. Additionally, APBA3, TCF12, and ZFR2, located on BTA7 and BTA10, were associated with the calving interval; PAX1, SGCD, and HAND1, located on BTA7 and BTA13, were linked to gestation length; and RBM47, UBE2K, and GPX8, located on BTA6 and BTA20, were linked to the number of artificial inseminations per conception in Hanwoo cows. Conclusions The findings of this study enhance our knowledge of the genetic factors that influence reproductive traits in Hanwoo cattle populations and provide a foundation for future breeding strategies focused on improving desirable traits in beef cattle. This research offers new evidence and insights into the genetic variants and genome regions associated with reproductive traits and contributes valuable information to guide future efforts in cattle breeding.

Abstract Background The lack of appropriate prognostic biomarkers remains a significant obstacle in the early detection of Head and Neck Squamous Cell Carcinoma (HNSCC), a cancer type with a high mortality rate. Despite considerable advancements in treatment, the success in diagnosing HNSCC at an early stage still needs to be improved. Nuclear factor erythroid 2-related factor 2 (Nrf2) and Sonic Hedgehog (Shh) are overexpressed in various cancers, including HNSCC, and have recently been proposed as possible therapeutic targets for HNSCC. Circulating Tumor Cell (CTC) is a novel concept used for the early detection of cancers, and studies have suggested that a higher CTC count is associated with the aggressiveness of HNSCC and poor survival rates. Therefore, we aimed to establish molecular markers for the early diagnosis of HNSCC considering Shh/Nrf2 overexpression in the background. In addition, the relation between Shh/Nrf2 and CTCs is still unexplored in HNSCC patients. Methods In the present study, we selected a cohort of 151 HNSCC patients and categorized them as CTC positive or negative based on the presence or absence of CTCs in their peripheral blood. Data on demographic and clinicopathological features with the survival of the patients were analyzed to select the patient cohort to study Shh/Nrf2 expression. Shh and Nrf2 expression was measured by qRT-PCR. Results Considering significant demographic [smoking, betel leaf (p-value

Abstract Background Studies indicate that ethnicity and socioeconomic disparity are significant facilitators for COVID-19 mortality. The United Arab Emirates, distinctly has a population of almost 12% citizens and the rest, immigrants, are mainly unskilled labourers. The disparate socio-economic structure, crowded housing conditions, and multi-ethnic population offer a unique set of challenges in COVID-19 management. Methods Patient characteristics, comorbidities, and clinical outcomes data from the electronic patient medical records were retrospectively extracted from the hospital information system of the two designated public COVID-19 referral hospitals. Chi-square test, logistic regression, and odds ratio were used to analyse the variables. Results From, the total of 3072 patients, less than one-fifth were females; the Asian population (71.2%);followed by Middle Eastern Arabs (23.3%) were the most infected by the virus. Diabetes Mellitus (26.8%), hypertension (25.7%) and heart disease (9.6%) were the most prevalent comorbidities observed among COVID-19 patients. Kidney disease as comorbidity significantly diminished the survival rates (Crude OR 9.6, 95% CI (5.6–16.6), p

Abstract Background Genomic comparison of Mycoplasma synoviae vaccine strain MS-H and the MS-H parental strain 86,079/7NS established a preliminary profile of genes related to attenuation of MS-H. In this study we aimed to identify the stability of mutations found in MS-H after passage in experimental or field chickens, and to evaluate if any reverse mutation may be associated with changes in characteristics of MS-H in vitro or in vivo. Results Whole genome sequence analysis of 5 selected MS-H field reisolates revealed that out of 32 mutations reported previously in MS-H, 28 remained stable, while four found to be reversible to the wild-type. Each isolate possessed mutations in one to three of the genes obg, oppF 1 and gap and/or a non-coding region. Examination of the 4 reversible mutations by protein modeling predicted that only two of them (in obg and oppF 1 genes) could potentially restore the function of the respective protein to that of the wild-type. Conclusions These results suggest that the majority of the MS-H mutations are stable after passage in vaccinated chickens. Characterisation of stable mutations found in MS-H could be utilised to develop rapid diagnostic techniques for differentiation of vaccine from field strains or ts- MS-H reisolates.

Abstract Background The use of fluoroscopically-guided interventional (FGI) procedures by orthopedic surgeons has been increasing. This study aimed to investigate the occupational radiation exposure among orthopedic surgeons in South Korea. Methods A nationwide survey of orthopedic surgeons was conducted in South Korea in October 2017. The dosimetry data of the participants were obtained from the National Dosimetry Registry. The orthopedic surgeons were categorized by job specialty [spine or trauma specialists, other orthopedic specialists, and residents], and descriptive statistics for the demographics and work-related characteristics were presented. Multivariable logistic regression analysis was used to evaluate the risk factors for the orthopedic surgeons who were not linked with the dosimetry data. Results Among the total participants (n = 513), 40.5% of the orthopedic surgeons spent more than 50% of their time working with the FGI procedures when compared with their overall work. The average frequency of the FGI procedures among the orthopedic surgeons was 12.3 days per month. Less than 30% of the participants were regularly provided with radiation monitoring badges. The proportion of subjects who always wore lead aprons and thyroid shields were 52 and 29%, respectively. The residents group experienced more unfavorable working conditions of radiation exposure than the other specialists. The dosimetry data were not significantly linked among the residents (odds ratio [OR] 2.10, 95% confidence interval [CI] 1.11–3.95) and orthopedic surgeons working at small hospitals (OR 4.76, 95% CI 1.05–21.51). Conclusions Although orthopedic surgeons often performed FGI procedures, they wore protective gear less frequently, and a large proportion of orthopedic surgeons were not monitored by the national radiation dosimetry system. As the number of radiation procedures performed by the orthopedic surgeons increases, more intensive approaches are needed to reduce radiation exposure, especially for spine and trauma surgeons.

Abstract Background Owing to the continuous increase in the number of new human immunodeficiency virus (HIV) infection in Korea, public health centers (PHCs) have performed anonymous tests since 1989. No study has examined the patterns of anonymous HIV testing performed at PHCs and the characteristics of HIV infection detected in those tests. We aimed to assess the influence of anonymous HIV testing on Korea’s national HIV surveillance. Methods HIV screening test data from 253 PHCs over a 16-year period were classified into 13 groups based on reason for testing. For anonymous HIV test takers (Anonymous), the HIV positivity per 10,000 tests was calculated, as repetitions could not be distinguished. Those with suspected HIV infection voluntarily underwent HIV testing and revealed their identity (Suspected). HIV prevalence was calculated as the number of HIV-positive persons per 10,000 test takers. Analyses were performed using chi-square and Cochran-Armitage trend test with SAS 9.4. Results Approximately 400,000 HIV screening tests were performed at PHCs annually, which remained unchanged in the past 10 years. The proportion of anonymous testing increased from

Abstract Background Although hepatitis B vaccinations have been integrated in the Universal Immunization Program (UIP) in India over a decade, only half of the children are immunized against hepatitis B. The national average in hepatitis B vaccination conceals large variations across states, districts and socio-economic groups. In this context, the aim of this paper is to examine the spatial heterogeneity and contextual determinants of hepatitis B vaccination across the districts of India. Methods Using data of 199,899 children aged 12–59 months from the National Family Health Survey-4 (NFHS-4), 2015–16 we have examined the district level spatial distribution and clustering of hepatitis B vaccination with the help of Moran’s I and Local Indicator of Spatial Autocorrelation (LISA) measures. We investigated the low coverage of HBV vaccination using spatial autoregressive models (SAR) at the meso scale. And we applied multivariate binary logistic regression analysis to understand the micro-level predictors of hepatitis B vaccination. Results In 2015–16, 45% of the children aged 12–59 months were not vaccinated against hepatitis B in India. The coverage of hepatitis B vaccine across the districts of India showed a highly significant spatial dependence (Moran’s I = 0.580). Bivariate Moran’s I confirmed the spatial clustering of hepatitis B vaccination with mother’s education, full antenatal care (ANC) utilization, post natal care (PNC) utilization, institutional births and registration of births at the district level. Districts with a very low coverage of HBV vaccine are clustered in the western, north-eastern regions and in some parts of central India. At the unit (child) level, children’s hepatitis B immunization status is mostly determined by the socio-economic and demographic characteristics like their mother’s educational status, caste, religion, household’s wealth condition, birth order, year of birth and the region they belong to. Conclusions District level variation in hepatitis B vaccination is spatially heterogeneous and clustered in India with a strong neighbourhood effect. Uptake of hepatitis B vaccine among Indian children is predominantly dependent upon their socio-economic and demographic characteristics.

Abstract Background Thyroid cancer rates, especially among children, are known to be increased by radiation exposure. However, little is known about the impact of chronic low-dose radiation exposure on thyroid cancer risk in adulthood. This study examined radiation effects on thyroid cancer rates as well as an overall evaluation of thyroid cancer risk among medical radiation workers. Methods Data on all diagnostic medical radiation workers enrolled in the national dosimetry registry between 1996 and 2011 were linked with the cancer registry data through 2015. Standardized incidence ratios (SIRs) were used to compare the observed cancer incidence rates in this population to those for the general population while internal comparisons were used to estimate relative risks (RRs) for occupational history and excess relative risks (ERRs) were used to quantify the radiation dose-response relationship. Results Overall, 827 thyroid cancer cases were reported among 93,922 medical radiation workers. Thyroid cancer SIRs were significantly higher than expected for both men (SIR 1.72, 95% confidence interval [CI] 1.53 to 1.91) and women (SIR 1.18, 95% CI 1.08 to 1.28). However, RRs for thyroid cancer by job title and duration of employment showed no particular pattern among diagnostic medical radiation workers. There were no indications of a significant dose effect on thyroid cancer rates for either men (ERR/100 mGy 0.07, 95% CI -0.38 to 0.53) or women (ERR/100 mGy -0.13, 95% CI -0.49 to 0.23). The findings were similar for different job titles or when limited to workers employed for at least one year. Conclusions While thyroid cancer incidence rates among Korean medical radiation workers were somewhat higher than those in the general population, there was no significant evidence that this increase was associated with occupational radiation dose. Additional follow-up together with consideration of other risk factors should provide useful information on thyroid cancer rates in this cohort.

Abstract Background The burden of rare diseases on society and patients’ families has increased in Korea. However, because of the infrequency of rare diseases, there is a lack of resources and information to address these cases and inadequate funding for the management of these patients. We investigated the average annual cumulative incidence of rare diseases and the trends in annual cumulative incidence from 2011 to 2015 in Korea by using nationwide administrative data from the Korean National Health Insurance Service (NHIS) database for patients registered with the co-payment assistance policy for rare and incurable diseases. Annual cumulative incidence per 10,000,000 was calculated as the total number of newly enrolled patients with the Korean Standard Classification of Diseases (KCD)-7 code in the register, divided by the number of residents with health insurance coverage during each year. We employed simple linear regression analysis to evaluate the trends in annual cumulative incidence/10,000,000 population per year for each rare disease. Results Overall, national support was provided for patients with 415 KCD codes listed among the targeted rare diseases. The total number of newly enrolled patients with rare diseases was 53,831 in 2011, 52,658 in 2012, 52,955 in 2013, 71,530 in 2014, and 70,559 in 2015. The number of rare diseases with an average annual cumulative incidence of 100/10,000,000 and above was 22 (5.30%), while there were 227 (54.70%) and 148 (35.66%) with an average cumulative incidence between 1/10,000,000 and 100/10,000,000 and less than 1/10,000,000, respectively. The trends in the annual cumulative incidence for 43 rare diseases were statistically significant (p-value

Abstract Background Timely assessment of cancer risk from current radiation exposure among medical radiation workers can contribute to the development of strategies to prevent excessive occupational radiation exposure. The purpose of the present study is to estimate the lifetime risk of cancers induced by occupational radiation exposure among medical radiation workers. Methods Using estimated organ doses and the RadRAT risk assessment tool, the lifetime cancer risk was estimated among medical radiation workers who were enrolled in the Korean National Dose Registry from 1996 to 2011. Median doses were used for estimating the risk because of the skewed distribution of radiation doses. Realistic representative exposure scenarios in the study population based on sex, job start year, and occupational group were created for calculating the lifetime attributable risk (LAR) and lifetime fractional risk (LFR). Results The mean estimated lifetime cancer risk from occupational radiation exposure varied significantly by sex and occupational group. The highest LAR was observed in male and female radiologic technologists who started work in 1991 (264.4/100,000 and 391.2/100,000, respectively). Female workers had a higher risk of radiation-related excess cancer, although they were exposed to lower radiation doses than male workers. The higher LAR among women was attributable primarily to excess breast and thyroid cancer risks. LARs among men were higher than women in most other cancer sites. With respect to organ sites, LAR of colon cancer (44.3/100,000) was the highest in male radiologic technologists, whereas LAR of thyroid cancer (222.0/100,000) was the highest in female radiologic technologists among workers who started radiologic practice in 1991. Thyroid and bladder cancers had the highest LFR among radiologic technologists. Conclusions Our findings provide an assessment of the potential cancer risk from occupational radiation exposure among medical radiation workers, based on current knowledge about radiation risk. Although the radiation-related risk was small in most cases, it varied widely by sex and occupational group, and the risk would be underestimated due to the use of median, rather than mean, doses. Therefore, careful monitoring is necessary to optimize radiation doses and protect medical radiation workers from potential health risks, particularly female radiologic technologists.

An amendment to this paper has been published and can be accessed via the original article.

Abstract Background The persistence of latently Human immunodeficiency virus-1 (HIV-1) infected cellular reservoirs in resting CD4+ T cells is a major obstacle to HIV-1 eradication. The detailed mechanism of HIV-1 latency remains unclear. We investigated histones and their post-translational modification associated with HIV-1 latency in novel HIV-1 latently infected cell lines established previously, NCHA cells. Methods To examine histones and their modification linked with HIV-1 latency, the expression profiles for core histone proteins and histone deacetylases (HDACs) in NCHA cells were characterized by RT-PCR, ELISA, and western blot. The levels of histone acetylation and methylation at histone H3 Lys9 (H3K9) and Lys27 (H3K27) in HIV-1 latently infected cells were analyzed by western blot and chromatin immunoprecipitation-sequencing (ChIP-seq). Results The expression levels for four core histone proteins (H2A, H2B, H3 and H4) and HDACs (HDAC1-8) in NCHA cells were not significantly different from those in their parental cells. Histone H3K9 and H3K27 acetylations in NCHA cells showed no difference in parental and NCHA cells, whereas the levels of di- and tri-methylation were increased in NCHA cells. The expression of EED which is a component of polycomb repressive complex 2 (PRC2), and BMI1 and RING2 which are constituents of PRC1, were upregulated in NCHA cells. In addition, more ubiquitylation at histone H2A was detected in NCHA cells. Conclusions Our results suggest that tri-methylation of histone H3K27 and H2A ubiquitylation via polycomb group protein may play a crucial role in epigenetic silencing accounting for HIV-1 latency in NCHA cells.

Abstract Background Moxibustion is a traditional Chinese method that uses the heat generated by burning herbal preparations containing Artemisia vulgaris to stimulate acupuncture points. Considering moxibustion is closely related to acupuncture, it seems pertinent to evaluate the effectiveness of moxibustion as a treatment of symptoms of cancer. The objective of this review was to systematically assess the effectiveness of moxibustion for supportive cancer care. Methods We searched the literature using 11 databases from their inceptions to February 2010, without language restrictions. We included randomised clinical trials (RCTs) in which moxibustion was employed as an adjuvant treatment for conventional medicine in patients with any type of cancer. The selection of studies, data extraction, and validations were performed independently by two reviewers. Results Five RCTs compared the effects of moxibustion with conventional therapy. Four RCTs failed to show favourable effects of moxibustion for response rate compared with chemotherapy (n = 229, RR, 1.04, 95% CI 0.94 to 1.15, P = 0.43). Two RCTs assessed the occurrence of side effects of chemotherapy and showed favourable effects of moxibustion. A meta-analysis showed significant less frequency of nausea and vomiting from chemotherapy for moxibustion group (n = 80, RR, 0.38, 95% CIs 0.22 to 0.65, P = 0.0005, heterogeneity: χ2 = 0.18, P = 0.67, I2 = 0%). Conclusion The evidence is limited to suggest moxibustion is an effective supportive cancer care in nausea and vomiting. However, all studies have a high risk of bias so effectively there is not enough evidence to draw any conclusion. Further research is required to investigate whether there are specific benefits of moxibustion for supportive cancer care.

Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on joint health in overweight and normal weight adults diagnosed with osteoarthritis. Methods An 8-week placebo-controlled, randomized, double-blind study was conducted with four groups comparing the effects of NP 06-1 to placebo on overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo were given in a dose of two capsules (370 mg each) twice daily. The outcome measures were the Lequesne Algofunctional Index (LAI) for joint pain and movement as well as biomarkers of inflammation (C-reactive protein [CRP] and erythrocyte sedimentation rate [ESR]). Results Eighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. The mean total LAI scores at baseline for the four groups ranged from 11.4 to 12.4 (SD 1.2 to 2.4). Treatment for 8 weeks resulted in a statistical improvement in the LAI score in the overweight treatment group compared to placebo (6.3 ± 2.3 vs 11.8 ± 1.5; p < 0.0001). At 8 weeks, a similar result was observed in the normal weight groups (7.7 ± 1.4 vs 9.9 ± 0.9; p < 0.0001). There was a reduction in CRP levels with treatment in the overweight treatment group at 8 weeks (-0.62 ± 0.2; 49%) compared to baseline (p < 0.001) and to placebo (p < 0.001). For the normal weight participants, there were significant reductions in CRP compared to baseline, but not to the matched placebo group. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks. There was no significant change in ESR in any of the groups. Conclusion In this pilot study, NP 06-1 had beneficial effects on symptoms of osteoarthritis of the knee as measured using LAI scores and had anti-inflammatory effects as measured using CRP. Administration of NP 06-1 was also associated with weight loss, which may have been a contributing factor to the other benefits.

Abstract Background The objective of this clinical study was to assess the potential benefit of a dietary supplement, NP 06-1, on cardiovascular protective properties in overweight and normal weight adults diagnosed with osteoarthritis of the knee. Methods An 8-week, placebo-controlled, randomized, double-blind study was conducted with four groups, comparing the effects of NP 06-1 to placebo in overweight and normal weight subjects diagnosed with primary osteoarthritis of the knee. NP 06-1 (a combination of two botanical extracts; Phellodendron amurense bark and Citrus sinensis peel) or matching placebo was given in a dose of two capsules (370 mg each) twice daily. The outcome measures reported are lipid levels, weight, BMI, blood pressure and fasting glucose. Analyses of variance were used to compare changes of physiological measures over the trial period and between groups. Results Eighty (80) subjects were enrolled and 45 subjects completed the study. No serious adverse events were reported. NP 06-1 administration was associated with a general improvement in lipid levels. Both the overweight and normal weight treatment groups had significant reductions in triglycerides and LDL-cholesterol, as well as a significant increase in HDL-cholesterol compared to their respective control groups. Overall there were decreases in blood pressure in both overweight and normal weight treatment groups compared to respective placebo groups. There was also a significant decrease in fasting glucose levels in the overweight treatment group compared to the start of the study and to the overweight placebo group. There was no change in fasting blood sugar for the normal weight groups. Both overweight and normal weight treatment groups lost a significant amount of weight compared to their respective placebo groups. The overweight treatment group lost an average of 5% body weight after 8 weeks, which was associated with a significant loss in BMI over time. Conclusion In this pilot study NP 06-1 had a beneficial effect on cardiovascular risk factors; namely lipid levels, blood pressure and fasting glucose levels. Administration of NP 06-1 was also associated with weight loss.