Characterization of nanoparticles in silicon dioxide food additive.

Silicon dioxide (SiO2), in its amorphous form, is an approved direct food additive in the United States and has been used as an anticaking agent in powdered food products and as a stabilizer in the production of beer. While SiO2 has been used in food for many years, there is limited information regarding its particle size and size distribution. In recent years, the use of SiO2 food additive has raised attention because of the possible presence of nanoparticles. Characterization of SiO2 food additive and understanding their physicochemical properties utilizing modern analytical tools are important in the safety evaluation of this additive. Herein, we present analytical techniques to characterize some SiO2 food additives, which were obtained directly from manufacturers and distributors. Characterization of these additives was performed using dynamic light scattering (DLS), transmission electron microscopy (TEM), field emission scanning electron microscopy (FE-SEM), and single-particle inductively coupled plasma mass spectrometry (spICP-MS) after the food additive materials underwent different experimental conditions. The data obtained from DLS, spICP-MS, and electron microscopy confirmed the presence of nanosized (1-100 nm) primary particles, as well as aggregates and agglomerates of aggregates with sizes greater than 100 nm. SEM images demonstrated that most of the SiO2 food additives procured from different distributors showed similar morphology. The results provide a foundation for evaluating the nanomaterial content of regulated food additives and will help the FDA address current knowledge gaps in analyzing nanosized particles in commercial food additives.

Perspective: Peer Evaluation of Recommendations for CONSORT Guidelines for Randomized Controlled Trials in Nutrition.

Creating effective dietary guidance requires a rigorous evidence base that is predominantly developed from robust clinical trials or large-scale cohort studies, with the quality of the data available depending on the completeness and accuracy of their reporting. An international group of academics from 14 institutions in 12 different countries and on 5 continents, working on behalf of the Federation of European Nutrition Societies within its "Improving Standards in the Science of Nutrition" initiative, reviewed the Consolidated Standards of Reporting Trials (CONSORT) statement checklist as it pertains to nutrition trials. This perspective piece documents the procedure followed to gain input and consensus on the checklist previously published by this group, including its presentation and interrogation at the International Union of Nutritional Sciences International Congress of Nutrition 2022 (IUNS-ICN 22), inputs from a survey of journal editors, and its piloting on 8 nutrition trials of diverse designs. Overall, the initiative has been met with considerable enthusiasm. At IUNS-ICN 22, refinements to our proposal were elicited through a World Café method discussion with participating nutrition scientists. The contributing journal editors provided valuable insights, and the discussion led to the development of a potential tool specific to assess adherence to the proposed nutrition extension checklist. The piloting of the proposed checklist provided evidence from real-life studies that reporting of nutrition trials can be improved. This initiative aims to stimulate further discussion and development of a CONSORT-nutrition-specific extension.

A Mediterranean Diet and Walking Intervention to Reduce Cognitive Decline and Dementia Risk in Independently Living Older Australians: The MedWalk Randomized Controlled Trial Experimental Protocol, Including COVID-19 Related Modifications and Baseline Characteristics.

BACKGROUND: Several clinical trials have examined diet and physical activity lifestyle changes as mitigation strategies for risk factors linked to cognitive decline and dementias such as Alzheimer's disease. However, the ability to modify these behaviors longer term, to impact cognitive health has remained elusive. OBJECTIVE: The MedWalk trial's primary aim is to investigate whether longer-term adherence to a Mediterranean-style diet and regular walking, delivered through motivational interviewing and cognitive-behavioral therapy (MI-CBT), can reduce age-associated cognitive decline and other dementia risk factors in older, independently living individuals without cognitive impairment. METHODS: MedWalk, a one-year cluster-randomized controlled trial across two Australian states, recruited 60-90-year-old people from independent living retirement villages and the wider community. Participants were assigned to either the MedWalk intervention or a control group (maintaining their usual diet and physical activity). The primary outcome is 12-month change in visual memory and learning assessed from errors on the Paired Associates Learning Task of the Cambridge Neuropsychological Test Automated Battery. Secondary outcomes include cognition, mood, cardiovascular function, biomarkers related to nutrient status and cognitive decline, MI-CBT effectiveness, Mediterranean diet adherence, physical activity, quality of life, cost-effectiveness, and health economic evaluation.Progress and Discussion:Although COVID-19 impacts over two years necessitated a reduced timeline and sample size, MedWalk retains sufficient power to address its aims and hypotheses. Baseline testing has been completed with 157 participants, who will be followed over 12 months. If successful, MedWalk will inform interventions that could substantially reduce dementia incidence and ameliorate cognitive decline in the community. TRIAL REGISTRATION: Registered on the Australia New Zealand Clinical Trials Registry ANZCTR 12620000978965 (https://www.anzctr.org.au).

Interactions between Mediterranean Diet Supplemented with Dairy Foods and the Gut Microbiota Influence Cardiovascular Health in an Australian Population.

The impact of a Mediterranean diet on the intestinal microbiome has been linked to its health benefits. We aim to evaluate the effects of a Mediterranean diet supplemented with dairy foods on the gut microbiome in Australians at risk of cardiovascular disease. In a randomised controlled cross-over study, 34 adults with a systolic blood pressure ≥120 mmHg and with risk factors for cardiovascular disease were randomly allocated to a Mediterranean diet with 3-4 daily serves of dairy foods (Australian recommended daily intake (RDI) of 1000-1300 mg per day (MedDairy)) or a low-fat (LFD) control diet. Between each 8-week diet, participants underwent an 8-week washout period. Microbiota characteristics of stool samples collected at the start and end of each diet period were determined by 16S rRNA amplicon sequencing. MedDairy-associated effects on bacterial relative abundance were correlated with clinical, anthropometric, and cognitive outcomes. No change in the overall faecal microbial structure or composition was observed with either diet (p > 0.05). The MedDairy diet was associated with changes in the relative abundance of several bacterial taxa, including an increase in Butyricicoccus and a decrease in Colinsella and Veillonella (p < 0.05). Increases in Butyricicoccus relative abundance over 8 weeks were inversely correlated with lower systolic blood pressure (r = -0.38, p = 0.026) and positively correlated with changes in fasting glucose levels (r = 0.39, p = 0.019), specifically for the MedDairy group. No significant associations were observed between the altered taxa and anthropometric or cognitive measures (p > 0.05). Compared to a low-fat control diet, the MedDairy diet resulted in changes in the abundance of specific gut bacteria, which were associated with clinical outcomes in adults at risk of CVD.

Developing a Mediterranean Healthy Food Basket and an Updated Australian Healthy Food Basket Modelled on the Australian Guide to Healthy Eating.

INTRODUCTION: Australian healthy food baskets are typically modelled off the Government Guidelines for healthy eating. However, these baskets have not been updated recently, nor has there been a Mediterranean Diet basket developed for an Australian population despite research suggesting high adherence is possible and subsequent health benefits observed. Food baskets typically only present the nutrition profile or the cost of a basket, seldom both. METHODS: Baskets were developed based on the Australian Guide to Healthy Eating, The Mediterranean Diet and typical Australian dietary intake (Western Diet). Four reference families were created based on data from Australian censuses and population statistics. Seven-day meal plans for reference families were entered into Foodworks software and aimed to meet 100% of nutrition and energy requirements. Basket costs were calculated from Coles Australia online. RESULTS: The AGHE basket met all NRVs except for VLCN3 for the 7-year-old male (73% adequate intake). The Mediterranean Diet met all NRVs except zinc (44-year-old male) ranging from 98 to 257% of the RDI. The Western Diet failed to meet NRVs for numerous nutrients. The MedDiet baskets were generally cheaper ($78 for a one-person household to $285 for a four-person household) than AGHE and Western Diet. DISCUSSION: Meeting nutrition requirements over seven days for zinc can be challenging for males. Fortified products provide an opportunity to improve nutrient profile; however, nutrient intake should equilibrate over time. Further, cost saving strategies can increase affordability. This research suggests a MedDiet is not more costly than a typical Western Diet or healthy AGHE diet.

A nutritional biomarker score of the Mediterranean diet and incident type 2 diabetes: Integrated analysis of data from the MedLey randomised controlled trial and the EPIC-InterAct case-cohort study.

BACKGROUND: Self-reported adherence to the Mediterranean diet has been modestly inversely associated with incidence of type 2 diabetes (T2D) in cohort studies. There is uncertainty about the validity and magnitude of this association due to subjective reporting of diet. The association has not been evaluated using an objectively measured biomarker of the Mediterranean diet. METHODS AND FINDINGS: We derived a biomarker score based on 5 circulating carotenoids and 24 fatty acids that discriminated between the Mediterranean or habitual diet arms of a parallel design, 6-month partial-feeding randomised controlled trial (RCT) conducted between 2013 and 2014, the MedLey trial (128 participants out of 166 randomised). We applied this biomarker score in an observational study, the European Prospective Investigation into Cancer and Nutrition (EPIC)-InterAct case-cohort study, to assess the association of the score with T2D incidence over an average of 9.7 years of follow-up since the baseline (1991 to 1998). We included 22,202 participants, of whom 9,453 were T2D cases, with relevant biomarkers from an original case-cohort of 27,779 participants sampled from a cohort of 340,234 people. As a secondary measure of the Mediterranean diet, we used a score estimated from dietary-self report. Within the trial, the biomarker score discriminated well between the 2 arms; the cross-validated C-statistic was 0.88 (95% confidence interval (CI) 0.82 to 0.94). The score was inversely associated with incident T2D in EPIC-InterAct: the hazard ratio (HR) per standard deviation of the score was 0.71 (95% CI: 0.65 to 0.77) following adjustment for sociodemographic, lifestyle and medical factors, and adiposity. In comparison, the HR per standard deviation of the self-reported Mediterranean diet was 0.90 (95% CI: 0.86 to 0.95). Assuming the score was causally associated with T2D, higher adherence to the Mediterranean diet in Western European adults by 10 percentiles of the score was estimated to reduce the incidence of T2D by 11% (95% CI: 7% to 14%). The study limitations included potential measurement error in nutritional biomarkers, unclear specificity of the biomarker score to the Mediterranean diet, and possible residual confounding. CONCLUSIONS: These findings suggest that objectively assessed adherence to the Mediterranean diet is associated with lower risk of T2D and that even modestly higher adherence may have the potential to reduce the population burden of T2D meaningfully. TRIAL REGISTRATION: Australian New Zealand Clinical Trials Registry (ANZCTR) ACTRN12613000602729 https://www.anzctr.org.au/Trial/Registration/TrialReview.aspx?id=363860.

Perspectives on the application of CONSORT guidelines to randomised controlled trials in nutrition.

PURPOSE: Reporting guidelines facilitate quality and completeness in research reporting. The CONsolidated Standards Of Reporting Trials (CONSORT) statement is widely applied to dietary and nutrition trials but has no extension specific to nutrition. Evidence suggests poor reporting in nutrition research. The Federation of European Nutrition Societies led an initiative to make recommendations for a nutrition extension to the CONSORT statement towards a more robust reporting of the evidence base. METHODS: An international working group was formed of nutrition researchers from 14 institutions in 12 different countries and on five continents. Using meetings over a period of one year, we interrogated the CONSORT statement specifically for its application to report nutrition trials. RESULTS: We provide a total of 28 new nutrition-specific recommendations or emphasised recommendations for the reporting of the introduction (three), methods (twelve), results (five) and discussion (eight). We also added two additional recommendations that were not allocated under the standard CONSORT headings. CONCLUSION: We identify a need to provide guidance in addition to CONSORT to improve the quality and consistency of the reporting and propose key considerations for further development of formal guidelines for the reporting of nutrition trials. Readers are encouraged to engage in this process, provide comments and conduct specific studies to inform further work on the development of reporting guidelines for nutrition trials.

Adherence to a Mediterranean Diet for 6 Months Improves the Dietary Inflammatory Index in a Western Population: Results from the MedLey Study.

Increasing evidence supports that a higher dietary inflammatory index (DII®) score is associated with inflammation and cardiovascular disease (CVD) risk, events, and mortality. This randomized trial sought to determine if a change to a Mediterranean diet resulted in a reduction in the DII score, and then it evaluated the relationship between the DII and cardiometabolic outcomes following the administration of a traditional Mediterranean diet in older Australian adults. A total of 152 Australian adults (mean age 71 ± 5 years) was randomly allocated either a MedDiet (n = 80) or to continue their habitual diet (HabDiet) (n = 72) for 6 months. Diet and cardiovascular outcomes were measured at baseline and 3 and 6 months of the intervention. DII and energy-adjusted DII (E-DIITM) scores were calculated from 3-day weighed food records. There was a significant reduction in the DII score at 2 and 4 months for the MedDiet group (−1.40 ± 0.20 p < 0.001 and −1.47 ± 0.20 p < 0.001, respectively), which was significantly different from the HabDiet group over time (p < 0.001). The HabDiet DII score did not change significantly at the 2 and 4 months timepoints (0.47 ± 0.21 p = 0.35 and 0.54 ± 0.21 p = 0.21, respectively). The improvement in the DII in the MedDiet group was not related to any cardiometabolic outcome. Baseline cross-sectional analyses identified a positive association between the E-DII score and average BMI, body weight, WHR, abdominal adiposity, and SBP, and a negative association with HDL-C. We demonstrate that a MedDiet intervention significantly reduced DII scores compared with a habitual Australian diet in older Australians. This could be beneficial for healthy ageing and the avoidance of chronic disease in Western populations.

Long-Term Adherence to a Mediterranean Diet 1-Year after Completion of the MedLey Study.

Mediterranean populations enjoy the health benefits of a Mediterranean diet (MedDiet), but is it feasible to implement such a pattern beyond the Mediterranean region? The MedLey trial, a 6-month MedDiet intervention vs habitual diet in older Australians, demonstrated that the participants could maintain high adherence to a MedDiet for 6 months. The MedDiet resulted in improved systolic blood pressure (BP), endothelial dilatation, oxidative stress, and plasma triglycerides in comparison with the habitual diet. We sought to determine if 12 months after finishing the MedLey study, the participants maintained their adherence to the MedDiet principles and whether the reduction in the cardiovascular disease (CVD) risk factors that were seen in the trial were sustained. Participants completed a food frequency questionnaire, and a 15-point MedDiet adherence score (MDAS; greater score = greater adherence) was calculated. Home BP was measured over 6 days, BMI was assessed, and fasting plasma triglycerides were measured. The data were analysed using intention-to-treat linear mixed effects models with a group × time interaction term, comparing data at baseline, 2, 4, and 18 months (12 months post-trial). At 18 months (12 months after finishing the MedLey study), the MedDiet group had a MDAS of 7.9 ± 0.3, compared to 9.6 ± 0.2 at 4 months (p < 0.0001), and 6.7 ± 0.2 (p < 0.0001), at baseline. The MDAS in the HabDiet group remained unchanged over the 18-month period (18 months 6.9 ± 0.3, 4 months 6.9 ± 0.2, baseline 6.7 ± 0.2). In the MedDiet group, the consumption of olive oil, legumes, fish, and vegetables remained higher (p < 0.01, compared with baseline) and discretionary food consumption remained lower (p = 0.02) at 18 months. These data show that some MedDiet principles could be adhered to for 12 months after finishing the MedLey trial. However, improvements in cardiometabolic health markers, including BP and plasma triglycerides, were not sustained. The results indicate that further dietary support for behaviour change may be beneficial to maintaining high adherence and metabolic benefits of the MedDiet.

Developing and Piloting a Novel Ranking System to Assess Popular Dietary Patterns and Healthy Eating Principles.

A multitude of weight loss diets exist. However, no one diet has been proven to be superior, despite their claims. Resultingly, this creates confusion amongst consumers and conflicting nutrition messages. The aim of the ranking system was to evaluate a range of dietary pattern's nutrition profile and financial costs, as well as their potential long-term sustainability and associated adverse effects. Nutrition profile is typically the focal point of weight loss diets with less attention focused towards other factors that may affect their suitability. Five popular diets (Keto, Paleo, Intermittent Fasting, Optifast, and 8 Weeks to Wow) and two energy restricted healthy eating principles (Australian Guide to Healthy Eating and the Mediterranean Diet) were compared for diet quality, cost, adverse effects, and support for behaviour change. In general, healthy eating principles scored more favourably compared to popular weight loss diets in all categories. Lower carbohydrate diets tended to score lower for diet quality due to restricting multiple food groups, had more associated adverse effects and did not encourage behaviour change compared to the other weight loss diets. Optifast was the only weight loss diet to receive a negative score for cost. There should be considerations when undertaking a change to dietary patterns beyond nutrition profile. Diets indeed vary in terms of diet quality, and in addition can be costly, incur adverse effects, and disregard behaviour change which is important for sustainable weight loss and maintenance. This ranking system could create a reference point for future comparisons of diets.

Effectiveness of sensory modulation for people with schizophrenia: A multisite quantitative prospective cohort study.

INTRODUCTION: Current research evidence suggests that people with schizophrenia have sensory processing difficulties. Sensory modulation has growing evidence for use in this population. This study aimed to evaluate the extent to which health, social, cognitive, and occupational functioning outcomes were impacted by sensory modulation interventions for people with schizophrenia. METHODS: A prospective observational cohort study using a waitlist control design was used in two large hospital and health services in Queensland, Australia. The study recruited patients who used sensory modulation (n = 30) across the two hospitals and those who did not use sensory modulation interventions as a control (n = 11). Results were analysed using a series of planned comparisons including independent and paired t-tests, and mixed ANOVA was used whenever statistically indicated. The analysed measures were pre- and post-intervention scores. RESULTS: This study found no statically significant differences between the control and intervention groups at both pre- and post-intervention. However, analysis of results from within the intervention group showed statistically significant improvements between pre- and post-test scores on distress, occupational functioning, and health and social functioning but not on sensory processing and global cognitive processing. Further analysis of results from this study, compared with those from an earlier study on the general population showed significant differences in Low Registration and Sensation Avoiding, as measured by the Adult/Adolescent Sensory Profile, between participants with schizophrenia and those without schizophrenia. CONCLUSION: This study provides evidence to suggest that sensory modulation interventions can be complementary to standard care when utilised appropriately in clinical settings. Findings also suggest that the sensory profile of people with schizophrenia is different to that of the general population and this may have clinical implications. Further longitudinal research is needed with larger and randomised samples, using more targeted measures to better explore effectiveness of sensory modulation interventions.

Versailles project on advanced materials and standards (VAMAS) interlaboratory study on measuring the number concentration of colloidal gold nanoparticles.

We describe the outcome of a large international interlaboratory study of the measurement of particle number concentration of colloidal nanoparticles, project 10 of the technical working area 34, "Nanoparticle Populations" of the Versailles Project on Advanced Materials and Standards (VAMAS). A total of 50 laboratories delivered results for the number concentration of 30 nm gold colloidal nanoparticles measured using particle tracking analysis (PTA), single particle inductively coupled plasma mass spectrometry (spICP-MS), ultraviolet-visible (UV-Vis) light spectroscopy, centrifugal liquid sedimentation (CLS) and small angle X-ray scattering (SAXS). The study provides quantitative data to evaluate the repeatability of these methods and their reproducibility in the measurement of number concentration of model nanoparticle systems following a common measurement protocol. We find that the population-averaging methods of SAXS, CLS and UV-Vis have high measurement repeatability and reproducibility, with between-labs variability of 2.6%, 11% and 1.4% respectively. However, results may be significantly biased for reasons including inaccurate material properties whose values are used to compute the number concentration. Particle-counting method results are less reproducibile than population-averaging methods, with measured between-labs variability of 68% and 46% for PTA and spICP-MS respectively. This study provides the stakeholder community with important comparative data to underpin measurement reproducibility and method validation for number concentration of nanoparticles.

Evaluation of the Potential of Single Particle ICP-MS for the Accurate Measurement of the Number Concentration of AuNPs of Different Sizes and Coatings.

Single particle inductively coupled plasma-mass spectrometry (spICP-MS) is an emerging technique that is capable of simultaneous measurement of the size and number concentration of metal-containing nanoparticles (NPs) at environmentally relevant levels. Although spICP-MS is widely applied to different fields, challenges remain in obtaining accurate and consistent particle number concentration (PNC) measurements. This paper presents, for the first time, a rigorous assessment of spICP-MS capabilities for measuring the PNC of gold NP (AuNP) suspensions of different sizes and coatings. The calibration of spICP-MS was accomplished with the National Institute of Standards and Technology (NIST) AuNP reference material (RM) 8013. The comparability of both spICP-MS direct and derived determination of PNC and reference PNC derived based on the mean particle size or the particle size distribution obtained by different reference sizing techniques was first assessed for NIST AuNP RM 8012, nominal diameter 30 nm. To enable a proper assessment of the accuracy of the spICP-MS results, a comprehensive estimation of the expanded uncertainty for PNC determination was carried out. Regardless of NP size or coating, a good agreement (90-110%) between spICP-MS direct determination of PNC and reported PNCs was obtained for all of the suspensions studied only when reliable in-house Au mass fractions and thorough mean particle size determinations were included in the calculation of the derived PNCs. The use of the particle size distribution over the mean size to derive PNCs resulted in larger differences for materials with a low contribution (<2%) of smaller NPs (30 nm), materials with a higher polydispersity (100 nm), or materials with two distinct subpopulations of particles (60 nm), regardless of NP coating.

Characterising activity and diet compositions for dementia prevention: protocol for the ACTIVate prospective longitudinal cohort study.

INTRODUCTION: Approximately 40% of late-life dementia may be prevented by addressing modifiable risk factors, including physical activity and diet. Yet, it is currently unknown how multiple lifestyle factors interact to influence cognition. The ACTIVate Study aims to (1) explore associations between 24-hour time-use and diet compositions with changes in cognition and brain function; and (2) identify duration of time-use behaviours and the dietary compositions to optimise cognition and brain function. METHODS AND ANALYSIS: This 3-year prospective longitudinal cohort study will recruit 448 adults aged 60-70 years across Adelaide and Newcastle, Australia. Time-use data will be collected through wrist-worn activity monitors and the Multimedia Activity Recall for Children and Adults. Dietary intake will be assessed using the Australian Eating Survey food frequency questionnaire. The primary outcome will be cognitive function, assessed using the Addenbrooke's Cognitive Examination-III. Secondary outcomes include structural and functional brain measures using MRI, cerebral arterial pulse measured with diffuse optical tomography, neuroplasticity using simultaneous transcranial magnetic stimulation and electroencephalography, and electrophysiological markers of cognitive control using event-related potential and time frequency analyses. Compositional data analysis, testing for interactions between time point and compositions, will assess longitudinal associations between dependent (cognition, brain function) and independent (time-use and diet compositions) variables. CONCLUSIONS: The ACTIVate Study will be the first to examine associations between time-use and diet compositions, cognition and brain function. Our findings will inform new avenues for multidomain interventions that may more effectively account for the co-dependence between activity and diet behaviours for dementia prevention. ETHICS AND DISSEMINATION: Ethics approval has been obtained from the University of South Australia's Human Research Ethics committee (202639). Findings will be disseminated through peer-reviewed manuscripts, conference presentations, targeted media releases and community engagement events. TRIAL REGISTRATION NUMBER: Australia New Zealand Clinical Trials Registry (ACTRN12619001659190).

Developing and implementing a new methodology to test the affordability of currently popular weight loss diet meal plans and healthy eating principles.

BACKGROUND: Weight loss diets continue to rise in popularity; however, the associated costs are seldom reported. Certain weight loss diets may be unaffordable and differ from their traditional nutrition composition to include non-conventional premium products. In contrast, healthy eating principles such as the Australian Guide to Healthy Eating (AGHE) and the Mediterranean Diet (MedDiet) place an emphasis on fresh produce and staple foods but are sometimes thought to be unaffordable. A new methodology was piloted to assess the cost of weight loss diets using seven meal plans. METHODS: Seven meal plans were analysed to quantify the absolute grams required of all ingredients across seven days and multiplied by the cost of the ingredient per gram to determine the total cost of each ingredient based on unit size and price. The weekly grocery shopping cost was determined through summation of all ingredients and their entire unit size to compare weekly costs. RESULTS: Weekly meal plans (absolute grams) cost between $93-193AUD. The AGHE meal plan was the least expensive and 8 Weeks to Wow was the most expensive. Weekly grocery shopping of entire units cost between $345-$625AUD, over $100AUD greater than the spending of an average Australian ($237AUD/week). CONCLUSIONS: The financial feasibility for long-term sustainment of weight loss diets may be questionable for groups including low-income earners and low socioeconomic status. Further, when dietary patterns are adapted for weight loss, or followed by consumers, deviations from foundational principles tend to occur which may influence overall cost.