Clinical characteristics of patients with non-alcoholic fatty liver disease (NAFLD) in Germany - First data from the German NAFLD-Registry.

BACKGROUND: Non-alcoholic fatty liver disease (NAFLD) affects more than 18 million individuals in Germany. Real-world data help to better characterize the natural history of disease and standard of care. METHODS: The German NAFLD-Registry is a prospective non-interventional study initiated by the German Liver Foundation and aims to describe clinical characteristics and observe outcomes in patients with NAFLD recruited in secondary and tertiary care. RESULTS: From this ongoing study, baseline data of the first 501 patients (mean age 54 years, 48% women) were analysed. 13 % of the study population had a high risk for advanced fibrosis (FIB-4 ≥2.67), approximately one-third had a liver stiffness value ≥9.6kPa measured by transient elastography, and the clinical diagnosis of liver cirrhosis was present in 10%. Typical comorbidities were more prevalent in high risk as compared to low risk patients (FIB-4 <1.3) including arterial hypertension (85 vs. 42%), hypercholesterolemia (39 vs. 16%), and type 2 diabetes mellitus (T2DM) (69 vs. 26%). Patients with T2DM (192/501) had a higher NAFLD disease burden as shown by liver stiffness values ≥9.6 kPa (51%) and clinical diagnosis of cirrhosis (20%). Statins were used in 22% of the main population, while in diabetic patients, metformin, GLP-1 agonists, and SGLT2 inhibitors were used in 65, 17, and 17%, respectively. Uptake of life-style interventions such as physical exercise or nutritional counselling was generally low. CONCLUSION: First data of the German NAFLD registry show that approximately every 10th patient has advanced NAFLD, highlights T2DM patients as a high-risk group and gives insights in the use of comedication and life-style interventions in secondary and tertiary care.

Updated epidemiology of hepatitis C virus infections and implications for hepatitis C virus elimination in Germany.

In 2014, an analysis was conducted to evaluate the hepatitis C virus (HCV) epidemiology and disease burden in Germany. Since then, there have been considerable developments in HCV management such as the implementation of direct acting antivirals. The aim of this analysis was to assess the recent data available for Germany, establish an updated 2020 HCV prevalence and cascade of care and evaluate the impact of what-if scenarios on the future burden of disease using modelling analysis. A dynamic Markov model was used to forecast the HCV disease burden in Germany. Model inputs were retrieved through literature review, unpublished sources and expert input. Next, three "what-if" scenarios were developed to evaluate the status quo, COVID-19 pandemic, and steps needed to achieve the WHO targets for elimination. At the beginning of 2020, there were 189,000 (95% UI: 76,700-295,000) viremic infections in Germany, a decline of more than 85,000 viremic infections since 2012. Annual treatment starts went down since 2015. Compared with 2019, the COVID-19 pandemic resulted in a further 11% decline in 2020. If this continues for two years, it could result in 110 excess HCC cases and 200 excess liver related deaths by 2030. To achieve the WHO targets, 81,200 people need to be diagnosed, with 118,600 initiated on treatment by 2030. This could also avert 1,020 deaths and 720 HCC cases between 2021 and 2030. Germany has made strides towards HCV elimination, but more efforts are needed to achieve the WHO targets by 2030.

Only partial improvement in health-related quality of life after treatment of chronic hepatitis C virus infection with direct acting antivirals in a real-world setting-results from the German Hepatitis C-Registry (DHC-R).

Improvement of health-related quality of life (HRQoL) is frequently reported as a benefit when treating hepatitis C virus infection (HCV) with direct acting antivirals (DAA). As most of the available data were obtained from clinical trials, limited generalizability to the real-world population might exist. This study aimed to investigate the impact of DAA therapy on changes in HRQoL in a real-world setting. HRQoL of 1180 participants of the German Hepatitis C-Registry was assessed by Short-Form 36 (SF-36) questionnaires. Scores at post-treatment weeks 12-24 (FU12/24) were compared to baseline (BL). Changes of ≥2.5 in mental and physical component summary scores (MCS and PCS) were defined as a minimal clinical important difference (MCID). Potential predictors of HRQoL changes were analysed. Overall, a statistically significant increase in HRQoL after DAA therapy was observed, that was robust among various subgroups. However, roughly half of all patients failed to achieve a clinically important improvement in MCS and PCS. Low MCS (p < .001, OR = 0.925) and PCS (p < .001, OR = 0.899) BL levels were identified as predictors for achieving a clinically important improvement. In contrast, presence of fatigue (p = .023, OR = 1.518), increased GPT levels (p = .005, OR = 0.626) and RBV containing therapy regimens (p = .001, OR = 1.692) were associated with a clinically important decline in HRQoL after DAA therapy. In conclusion, DAA treatment is associated with an overall increase of HRQoL in HCV-infected patients. Nevertheless, roughly half of the patients fail to achieve a clinically important improvement. Especially patients with a low HRQoL seem to benefit most from the modern therapeutic options.

[Evolution of hepatitis C virus genotype 1a vs. 1b distribution in Germany between 2004 and 2018 - An analysis of 17093 patients from different real world registries]. / Veränderungen der Hepatitis-C-Virus-Genotyp-1a/1b-Verteilung zwischen 2004 und 2018 in Deutschland ­ eine Analyse von 17093 Patienten aus verschiedenen Real-World-Registern.

BACKGROUND: Hepatitis C virus (HCV) genotype (GT) 1 is the most common HCV GT in Western and Central Europe. The main focus of this present work is to analyze the change of baseline characteristics of 17 093 HCV-patients with genotype 1a/1b with antiviral therapy in Germany between 2004 and 2018. We analyzed five periods: (i) 2004-2007, (ii) 2008-2010, (iii) 2010-2013, (iv) 2014-2016, (v) 2017-2018. METHODS: The present analysis is based on five German non-interventional registry studies and comprises data on 17 093 HCV-GT1 patients documented between 2004 and 2018 [ML17071, ML19464, ML21645, ML25724 (Peginterferon alfa-2a® non-interventional study [PAN]) and the German Hepatitis C-Registry (DHC-R). FINDINGS: Overall, 7662 patients were infected with HCV GT1a and 9431 patients with HCV GT1b. GT1a patients were younger (46.5 years vs. 51.2 years) and more often male (70 % vs. 52 %). Previous or ongoing drug abuse was documented more frequently for GT1a patients throughout the study periods with highest frequencies in the most recent period (2017-2018; 44 % for GT1a and 10.3 % for GT1b). Metabolic comorbidities, such as those who are overweight and those with diabetes mellitus, were associated with HCV GT1b-infected women. The GT1a ratio increased from 33.6 % (2004-2007) to 50 % (2017-2018). A relevant change in the GT1a/1b ratio was observed over time in men (2004-2007: 38 %/63 %; 2017-2018: 59 %/41 %). In contrast, only 30 % of women had GT1a infection throughout all study periods without relevant changes. There were no regional differences within Germany in HCV GT1a/1b distribution despite a higher proportion of GT1b-infected women in East Germany in 2004-2007 (86 %). CONCLUSION: A marked increase of GT1a infection associated with drug use was observed in men, but not women, in Germany between 2004 and 2018. The present data show a fundamental change in HCV epidemiology, which has an impact on therapy management and general care of hepatitis C patients in Germany.

[Problems in treating patients with chronic HCV infection due to the COVID-19 pandemic and during the lockdown phase in Germany]. / Versorgungsprobleme von Patienten mit chronischer Hepatitis C während der COVID-19-Pandemie und der Lockdown-Verordnungen.

BACKGROUND: Healthcare services were faced with unprecedented challenges due to the COVID-19 pandemic and its associated lockdown regulations. In order to analyse the influence of the pandemic on the healthcare of patients with chronic hepatitis C in Germany, we carried out a structured questionnaire among all centres participating in the German Hepatitis C-Registry (DHC-R). METHODS: 320 centres of the DHC-R were invited to participate in an online survey. Of these, 74 centres had included ≥ 5 patients in the last 12 months. FINDINGS: A fully answered questionnaire was sent back by 64 centres. Due to the lockdown regulations, 11 % of the centres had stopped their regular consultation between March and May 2020; 58 % had reduced the consultations and 32 % did not change the consultations. More than 50 % of the appointment cancellations were done by the patients. 52 % of the centres offered a new or additional telephone consultation and 17 % offered a new video consultation. Between March and May 2020, the number of patients newly treated with antivirals was markedly lower when compared with the same period in 2019. All centres had returned to their usual consultation procedures in July 2020. Almost 80 % indicated that there were no significant limitations in patient's healthcare. However, 22 % of the centres stated that liver decompensation was diagnosed late and 9.4 % stated that diagnosis of hepatocellular carcinoma was delayed. An adequate amount of personal protective equipment (including disinfectants) was available in 56 % of the centres. Official information by public healthcare authorities was considered sufficient by 63 % of the centres. SUMMARY: Diagnosis, therapy and monitoring of patients with chronic hepatitis C were impaired during the COVID-19 pandemic. Nevertheless, the majority of the centres did not see healthcare problems for these patients in the medium and long term. However, the fact that the diagnosis of liver decompensations with potential lethal consequences was delayed in a considerable number of patients causes major concern.

Sofosbuvir, velpatasvir, and voxilaprevir for patients with failure of previous direct-acting antiviral therapy for chronic hepatitis C: Results from the German Hepatitis C-Registry (DHC-R).

Despite the high effectiveness of direct-acting antivirals for the treatment of hepatitis C, a small proportion of patients do not respond to approved regimens. The combination regimen of SOF/VEL/VOX was recently approved for patients with failure to prior NS5A-based treatment. In this German real-world cohort including patients with cirrhosis (27.3 %) and previous decompensation events, 12 weeks of SOF/VEL/VOX resulted in high virologic response rates irrespective of disease severity and prior DAA regimen. Adverse events were mostly mild or moderate and comparable to those seen in the approval studies.

Treatment-failure to direct antiviral HCV regimens in real world: frequency, patient characteristics and rescue therapy - data from the German hepatitis C registry (DHC-R).

BACKGROUND: Virologic failure to approved combinations of direct antiviral agents (DAA) in patients with chronic hepatitis C virus (HCV) infection is rare. Mostly it involves difficult to treat patients with advanced liver disease and prior interferon-experience. Before approval of VOX/VEL/SOF, a restricted number of patients received rescue treatment, and the choice of DAA combinations for re-treatment were selected on an individual basis. In the present analysis, patient characteristics and rescue-regimens after virologic failure mainly based on first generation DAAs are described. PATIENTS AND METHODS: Data were obtained from the German Hepatitis C-Registry (DHC-R), which is a national multicenter real-world cohort currently including about 16 500 patients recruited by more than 250 centers. The present analysis is based on 6683 patients who initiated a DAA therapy and for whom follow-up data (per-protocol analysis) were available. RESULTS: Among the patients, 188 (2.8 %) experienced a virologic relapse. Compared to SVR-patients, relapse patients were significantly more often male (77.7 % versus 56.9 %, respectively, p < 0.001), showed cirrhosis significantly more (48.4 % versus 28.1 %, respectively, p < 0.001) and a prior interferon-containing therapy (46.3 % versus 39.0 %, respectively, p = 0.049). The majority of patients who relapsed were infected with genotype 1 (47.4 %) followed by genotype 3 (29.8 %), and 95 relapse patients started DAA re-treatment. Characteristics of patients with rescue-treatment are similar to these of patients with relapse after initial DAA treatment. Thirty-one of 39 patients with complete follow-up data achieved SVR (79.5 %), and 8 patients had a relapse again (20.5 %). Patients who received rescue treatment including a new DAA class according to guidelines, except patients who received VOX/VEL/SOF, showed higher SVR rates than the entire group (21/25, 84 %). All patients who received VOX/VEL/SOF achieved SVR (n = 4, 100 %). CONCLUSIONS: Patients with failure with DAA combination therapies are a difficult but urgent to treat population with the frequent presence of cirrhosis and prior treatment failure with interferon-based therapies. Rescue therapy with inclusion of a new DAA class leads to high SVR rates, but multiple targeted therapy with VOX/VEL/SOF seems to be most effective.

[4 years of direct-acting antivirals (DAAs) in the German Hepatitis C-Registry (DHC-R)]. / Deutsches Hepatitis C-Register (DHC-R) ­ eine Zwischenbilanz 4 Jahre nach Zulassung direkt antiviraler Substanzen (DAAs).

BACKGROUND: More than 250 000 patients suffer from chronic hepatitis C in Germany. Several potent, direct-acting antiviral drugs have been approved since 2014. The aim of the German Hepatitis C-Registry (DHC-R) is to describe the epidemiology and patient care of hepatitis C and to investigate the efficacy and safety of new treatment options in real-world settings. METHODS: The DHC-R is a prospective multicenter non-interventional registry study that includes 327 centers throughout Germany. All approved treatment options have been documented. The current analysis differentiated 4 phases: 2/2014 - 12/2014, 1/2015 - 12/2015, 1/2016 - 7/2017 and 8/2017 - 7/2018. FINDINGS: Between February 2014 and July 2018, 12 170 patients were included in the registry (61.3 % male), and antiviral treatment was initiated in 11 268. The mean age declined from 52.3 years (phase 1) to 49.3 years (phase 4), while the proportion of patients with previous or ongoing drug abuse increased (26.3 % to 43.1 %). In 2014, 35.1 % of treated patients had liver cirrhosis, which declined to 16.5 % in phase 4. The HCV genotype distribution showed marked fluctuations, with most recent increases in HCV genotype 3 (30 % in phase 4). Per-protocol sustained virological response rates increased from 92.8 % in 2014 to 94.4 % in 2017/18 with excellent tolerability. SUMMARY: The DHC-R mirrors patient care of chronic hepatitis in the real-world setting in Germany and provides insights into epidemiology developments. It also confirms the high efficacy and safety of novel treatment options.

Hepatitis C therapy with grazoprevir/elbasvir and glecaprevir/pibrentasvir in patients with advanced chronic kidney disease: data from the German Hepatitis C-Registry (DHC-R).

OBJECTIVES: Grazoprevir/elbasvir and glecaprevir/pibrentasvir (G/P) are the two preferred treatment options for patients with chronic hepatitis C virus (HCV) infection and a glomerular filtration rate (GFR) <30 mL/min. Both therapies have been separately analyzed in different real-life cohorts; however, a direct comparison has not been performed so far. We, therefore, analyzed safety and effectiveness of both regimens in a concerted real-life population. METHODS: The Germany Hepatitis C-Registry is a prospective national real-world registry. The analysis is based on 2773 patients with documented GFR at baseline treated with grazoprevir/elbasvir (N = 1041), grazoprevir/elbasvir + ribavirin (N = 53) and glecaprevir/pibrentasvir (N = 1679). RESULTS: A total of 93 patients with GFR <30 mL/min were treated with grazoprevir/elbasvir (N = 56), grazoprevir/elbasvir + ribavirin (N = 4), and glecaprevir/pibrentasvir (N = 33). They suffered significantly more frequent from diabetes mellitus, hypertension, and coronary heart disease than individuals with GFR >30 mL/min and showed the following baseline characteristics: 20.4, 55.9, 3.2, 12.9, and 5.3% were infected with HCV-genotypes 1a, 1b, 2, 3, and 4; 12.9% suffered from liver cirrhosis; 80.1% were treatment-naïve. Baseline characteristics except distribution of HCV-genotype 1b (n = 43/52 treated with grazoprevir/elbasvir) and sustained virologic response rates (SVR12) did not differ significantly between glecaprevir/pibrentasvir (SVR12: 100%) and grazoprevir/elbasvir (SVR12: 97.9%).Fatigue, headache, abdominal discomfort, and arthralgia were the most frequently reported adverse events without a statistical difference between grazoprevir/elbasvir and glecaprevir/pibrentasvir. CONCLUSION: In patients with chronic hepatitis C and a baseline GFR ≤30 mL/min grazoprevir/elbasvir and glecaprevir/pibrentasvir show an equally favorable safety profile and antiviral efficacy and can both be recommended for real-life use.

Weight Gain after Interferon-Free Treatment of Chronic Hepatitis C-Results from the German Hepatitis C-Registry (DHC-R).

Chronic hepatitis C can be treated very effectively with direct-acting antivirals (DAA) with only minor side effects compared to an interferon-containing treatment regimen. The significance of metabolic comorbidities after HCV cure is not well defined. This study aims to investigate short- and long-term weight change of patients receiving interferon-free antiviral treatment for chronic hepatitis C. The German Hepatitis C-registry (DHC-R) is a national multicenter real-world cohort. A total of 5111 patients were followed prospectively after DAA treatment for up to 3 years. Weight change compared to baseline was analyzed at end of treatment and at years 1, 2, and 3 after completion of antiviral therapy. Regression analysis was performed to identify baseline predictors for weight change. While there was no relevant mean weight change (-0.2 kg, SD 4.3 kg) at the end of antiviral treatment, weight started to increase during long-term follow-up reaching +1.7 kg (SD 8.0 kg, p < 0.001) compared to baseline at 3 years (follow-up year 3, FU3) after completion of antiviral therapy. 48%, 31%, and 22% of patients had a weight gain greater than 1, 3, and 5 kg at FU3, respectively. During follow-up, a body mass index (BMI) <30 proved to be the only consistent predictor for weight gain. DAA treatment is followed by a substantial weight gain (+3 kg or more) in one-third of the patients during long-term follow-up. Non-obese patients seemed to be most vulnerable to weight gain. The body compartment involved in weight gain as well as the mechanism of weight gain remain to be elucidated.

Hepatitis C therapy with direct antiviral agents in patients with advanced chronic kidney disease: real-world experience of the German Hepatitis C-Registry (Deutsches Hepatitis C-Register).

BACKGROUND: Direct-acting antiviral agents (DAAs) have revolutionized treatment of chronic hepatitis C in patients with normal glomerular filtration rate (GFR). However, patients with impaired kidney function have been excluded from several clinical trials. We, therefore, investigated the use, effectiveness, and tolerability of DAAs in patients with GFR less than 30 ml/min in the real-world setting. PATIENTS AND METHODS: An analysis was done within the German Hepatitis C-Registry on 5733 patients including 46 individuals with a baseline GFR less than 30 ml/min treated with sofosbuvir-based (61%) or paritaprevir/ritonavir-based (39%) regimens. RESULTS: Sustained virological response 12 rates did not differ significantly between patients with baseline GFR less than 30 versus more than 30 ml/min (91 vs. 96%). Nine individuals with a baseline GFR more than 30 ml/min presented with a GFR less than 30 ml/min at the end of treatment. GFR improvement from less than 30 ml/min to more than 30 ml/min was observed in 9/46 cases. Adverse events did not differ in patients with GFR less than 30 versus more than 30 ml/min. However, serious adverse events were significantly more frequent in individuals with GFR less than 30 ml/min and associated with ribavirin. CONCLUSION: Different DAA therapies can be safely used with high sustained virological response rates in patients with GFR less than 30 ml/min. Ribavirin has to be avoided because of poor tolerability.

Alcohol and Cannabis Consumption Does Not Diminish Cure Rates in a Real-World Cohort of Chronic Hepatitis C Virus Infected Patients on Opioid Substitution Therapy-Data From the German Hepatitis C-Registry (DHC-R).

BACKGROUND: The importance of alcohol and cannabis consumption for the effectiveness of treatment of chronic hepatitis C virus (HCV) infection with direct acting antivirals (DAAs) in people on opioid substitution therapy (OST) has not been investigated in detail. METHODS: We investigated sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST (n = 739) and non-OST patients (n = 7008) in the German Hepatitis C-Registry (Deutsches Hepatitis C-Register, DHC-R), which is a national multicenter prospective non-interventional real-world registry. Non-OST patients comprised patients with former/current drug use (non-OST/DU; n = 1500) and patients never consuming drugs (non-OST/NDU; n = 5508). FINDINGS: SVR 12/24 rates (intention to treat [ITT]) in patients consuming no or less than 30 g/day (women) or 40 g/day (men) were significantly higher in non-OST/NDU (range 91%-92%) vs OST patients (range 83%-86%), mainly due to significantly higher LTFU rates in OST (range 11%-12%) compared with non-OST/NDU (range 2%-3%). In non-OST/NDU with high alcohol consumption of more than 30/40 g/day, SVR 12/24 rates (ITT) were lower (85%) but did not differ to OST (85%) with high alcohol consumption. No significant differences could be seen for SVR 12/24 in per-protocol (PP) analysis independent of alcohol consumption or amount of alcohol intake. Cannabis use did not significantly influence SVR 12/24 in ITT or PP or LTFU. CONCLUSIONS: High SVR rates could be achieved in both OST and non-OST patients irrespective of alcohol or cannabis consumption. However, LTFU is more likely in patients with current or former drug use than in patients without drug history and in patients with high alcohol consumption but occurred mainly after end of antiviral treatment (EOT), leaving a high chance for HCV elimination in these patients.

Direct-acting antiviral treatment of chronic HCV-infected patients on opioid substitution therapy: Still a concern in clinical practice?

BACKGROUND AND AIMS: There is limited real-world information on the effectiveness of antiviral treatment of chronic hepatitis C virus (HCV) infection with direct-acting antivirals (DAA) in people on opioid substitution therapy (OST). This study compared sustained virological response (SVR) rates and proportion of lost to follow-up (LTFU) between OST and non-OST patients in the German Hepatitis C-Registry (DHC-R). DESIGN: National multi-centre prospective real-world registry (German Hepatitis C-Registry, DHC-R). Non-OST patients comprised patients with former/current drug use (non-OST/DU) and patients never consuming drugs (non-OST/NDU). SETTING: A total of 254 medical centres in Germany, including 123 centres providing OST. PARTICIPANTS: A total of 7747 chronic HCV patients started DAA therapy (739 OST and 7008 non-OST; 1500 non-OST/DU; 5508 non-OST/NDU) patients. Five hundred and twenty-eight OST and 5582 non-OST patients had completed antiviral therapy and at least one follow-up documentation [intention-to-treat (ITT) population]. MEASUREMENTS: Study outcomes were SVR, proportion of LTFU and safety of treatment. FINDINGS: SVR (ITT) was documented in 85% (450 of 528) OST patients versus 86% (969 of 1126) in non-OST/DU (P = 0.651) and 92% (4113 of 4456) non-OST/NDU (P < 0.001) patients. Independent predictors for SVR (P < 0.01 in multivariate analysis) included HCV genotype non-3 [adjusted odds ratio (aOR) = 1.11; 95% confidence interval (CI) = 1.07-1.15], female sex (aOR = 1.59; CI = 1.30-1.94), platelet counts >90 × 109/l (aOR = 1.51, CI = 1.14-2.01), cirrhosis (aOR = 0.77; CI = 0.62-0.96) and patient group (OST/DI (aOR = 0.58; CI = 0.42-0.78); non-OST/DU (OR: 0.63; CI = 0.50-0.78). In per-protocol analysis (PP), SVR rates were ≥ 94% in all patient groups. In OST the proportion of LTFU was higher (10.2%) than in non-OST/DU (8.5%) and non-OST/NDU (3.2%, P < 0.001) patients. Independent factors for LTFU (P < 0.01) were HCV genotype non-3 (aOR = 0.92; CI = 0.88-0.96), female sex (aOR: 0.7; CI = 0.53-0.92), pre-treatment (aOR = 0.64; CI = 0.50-0.82), OST/DI (aOR = 3.35; CI = 2.35-4.78) and non-OST/DU (aOR = 2.38; CI = 1.80-3.14). CONCLUSIONS: In Germany, direct-acting antiviral treatment of former or current drug users with or without opioid substitution therapy can achieve equally high sustained virological response rates as in patients with no history of drug use.

Impact of physicochemical characteristics on the oxidative stability of fish oil microencapsulated by spray-drying.

The aim of the present research was to identify principal parameters determining the oxidative stability of microencapsulated fish oil. Microcapsules were prepared by spray-drying using different types of n-octenylsuccinate-derivatized starch, gum Arabic, sugar beet pectin, sodium caseinate, and/or glucose syrup. Two principal components to classify the different microcapsules accounting for up to 79% of the variance were identified. The principal components were determined by physicochemical parameters reflecting the emulsifying ability of the encapsulant and the drying behavior of the parent emulsion. Microcapsules, which were identified by principal component analysis to be significantly different, exhibited a low stability upon storage, showing that the principal components and, thus, the underlying physicochemical parameters analyzed in the present study are correlated with core material stability.

Antimicrobial effect of emulsion-encapsulated isoeugenol against biofilms of food pathogens and spoilage bacteria.

Food-related biofilms can cause food-borne illnesses and spoilage, both of which are problems on a global level. Essential oils are compounds derived from plant material that have a potential to be used in natural food preservation in the future since they are natural antimicrobials. Bacterial biofilms are particularly resilient towards biocides, and preservatives that effectively eradicate biofilms are therefore needed. In this study, we test the antibacterial properties of emulsion-encapsulated and unencapsulated isoeugenol against biofilms of Lis. monocytogenes, S. aureus, P. fluorescens and Leu. mesenteroides in tryptic soy broth and carrot juice. We show that emulsion encapsulation enhances the antimicrobial properties of isoeugenol against biofilms in media but not in carrot juice. Some of the isoeugenol emulsions were coated with chitosan, and treatment of biofilms with these emulsions disrupted the biofilm structure. Furthermore, we show that addition of the surfactant Tween 80, which is commonly used to disperse oils in food, hampers the antibacterial properties of isoeugenol. This finding highlights that common food additives, such as surfactants, may have an adverse effect on the antibacterial activity of preservatives. Isoeugenol is a promising candidate as a future food preservative because it works almost equally well against planktonic bacteria and biofilms. Emulsion encapsulation has potential benefits for the efficacy of isoeugenol, but the effect of encapsulation depends on the properties of food matrix in which isoeugenol is to be applied.

Enhancing the antibacterial efficacy of isoeugenol by emulsion encapsulation.

Food spoilage and foodborne illnesses are two global challenges for food manufacturers. Essential oils are natural antibacterials that could have a potential for use in food preservation. Unfortunately high concentrations are needed to obtain the desired antibacterial effect, and this limits their use in food due to their adverse organoleptic properties. Encapsulation could make essential oils more effective by concentrating them in the aqueous phase of the food matrix where the bacteria are present. Here we tested encapsulation of the essential oil isoeugenol in spray-dried emulsions as a means of making isoeugenol a more effective antibacterial for use in food preservation. We used ß-lactoglobulin and n-OSA starch as emulsifiers, and some emulsions were coated with positively charged chitosan to promote the contact with bacteria through electrostatic interactions. The antibacterial efficacy was quantified as the minimal bactericidal concentration in growth media, milk and carrot juice. The emulsion encapsulation system developed in this study provided high loading capacities, and encapsulation enhanced the efficacy of isoeugenol against Gram-positive and -negative bacteria in media and carrot juice but not in milk. Chitosan-coating did not enhance the efficacy further, possibly due to the aggregation of the chitosan-coated emulsions. The encapsulation system is easy to upscale and should be applicable for encapsulation of similar essential oils. Therefore, we believe it has potential to be used for natural food preservation.

Comparative Evaluation of Diagnostic Tools for Oxidative Deterioration of Polyunsaturated Fatty Acid-Enriched Infant Formulas during Storage.

The challenge in the development of infant formulas enriched with polyunsaturated fatty acids (PUFAs) is to meet the consumers' expectations with regard to high nutritional and sensory value. In particular, PUFAs may be prone to fatty acid oxidation that can generate potential rancid, metallic and/or fishy off-flavors. Although such off-flavors pose no health risk, they can nevertheless lead to rejection of products by consumers. Thus, monitoring autoxidation at its early stages is of great importance and finding a suitable analytical tool to perform these evaluations is therefore of high interest in quality monitoring. Two formulations of infant formulas were varied systematically in their mineral composition and their presence of antioxidants to produce 18 model formulas. All models were aged under controlled conditions and their oxidative deterioration was monitored. A quantitative study was performed on seven characteristic odor-active secondary oxidation products in the formulations via two-dimensional high resolution gas chromatography-mass spectrometry/olfactometry (2D-HRGC-MS/O). The sensitivity of the multi-dimensional GC-MS/O analysis was supported by two additional analytical tools for monitoring autoxidation, namely the analysis of lipid hydroperoxides and conjugated dienes. Furthermore, an aroma profile analysis (APA) was performed to reveal the presence and intensities of typical odor qualities generated in the course of fatty acid oxidation. The photometrical analyses of lipid hydroperoxides and conjugated dienes were found to be too insensitive for early indication of the development of sensory defects. By comparison, the 2D-HRGC-MS/O was capable of monitoring peroxidation of PUFAs at low ppb-level in its early stages. Thereby, it was possible to screen oxidative variances on the basis of such volatile markers already within eight weeks after production of the products, which is an earlier indication of oxidative deterioration than achievable via conventional methods. In detail, oxidative variances between the formulations revealed that lipid oxidation was low when copper was administered in an encapsulated form and when antioxidants (vitamin E, ascorbyl palmitate) were present.