Bladder Tumor-Focused Adaptive Radiation Therapy: Clinical Outcomes of a Phase I Dose Escalation Study.

PURPOSE: We determine the maximum tolerated tumor-focused dose (MTD) for the radical treatment of muscle invasive bladder cancer enabled by image guided adaptive radiation therapy and long-term clinical outcomes. METHODS AND MATERIALS: Fifty-nine patients with T2 to T4aN0M0 unifocal urothelial muscle invasive bladder cancer suitable for daily radical radiation therapy were recruited prospectively to an ethics-approved protocol (NCT01124682). The uninvolved bladder (PTVbladder) was planned to 52 Gy in 32 fractions. The bladder tumor (PTVtumor) was planned to an assigned dose level of 68, 70, 72, or 74 Gy. If organ at risk dose constraints were violated, then PTVtumor was planned to 64 Gy. Dose level allocation was determined by concurrent toxicity assessment of all previous patients recruited. Acute toxicity was evaluated using Common Terminology Criteria for Adverse Events v3.0; late toxicity was evaluated using Radiation Therapy Oncology Group criteria. The MTD was predefined as the highest dose level with an estimated probability of ≤ 15% ≥ G3 late toxicity and an observed rate of <50% acute G3 and <10% acute G4 toxicity. RESULTS: Twenty-six patients were assigned to 68 Gy, of whom 6 were planned to 64 Gy; 29 patients were assigned to 70 Gy of whom 1 was planned to 68 Gy, 2 patients were assigned and planned to 72 Gy; no patients were assigned to 74 Gy. Three patients did not complete the treatment as planned, of whom only 1 patient stopped treatment because dose-limiting toxicity occurred. The MTD was 70 Gy. Acute genito-urinary and gastro-intestinal G3 acute toxicity was seen in 19% and 7% of patients, respectively. No acute G4 genito-urinary or gastro-intestinal toxicity was seen. Late toxicity (any) G3 and G4 was seen in 14% and 2% of patients, respectively. The 5-year overall survival was 58% (95% CI, 44%-71%). The bladder preservation rate was 89% (95% CI, 88%-96%) with 6 patients not retaining native bladder function. CONCLUSIONS: Bladder tumor-focused dose escalation to 70 Gy using image guided adaptive radiation therapy is feasible with acceptable toxicity. This dose level has been evaluated in a phase II randomized control trial (RAIDER NCT02447549).

Impact of on-trial IGRT quality assurance in an international adaptive radiotherapy trial for participants with bladder cancer.

BACKGROUND AND PURPOSE: Radiotherapy trial quality assurance (RT QA) is crucial for ensuring the safe and reliable delivery of radiotherapy trials, and minimizing inter-institutional variations. While previous studies focused on outlining and planning quality assurance (QA), this work explores the process of Image-Guided Radiotherapy (IGRT), and adaptive radiotherapy. This study presents findings from during-accrual QA in the RAIDER trial, evaluating concordance between online and offline plan selections for bladder cancer participants undergoing adaptive radiotherapy. RAIDER had two seamless stages; stage 1 assessed adherence to dose constraints of dose escalated radiotherapy (DART) and stage 2 assessed safety. The RT QA programme was updated from stage 1 to stage 2. MATERIALS AND METHODS: Data from all participants in the adaptive arms (standard dose adaptive radiotherapy (SART) and DART) of the trial was requested (33 centres across the UK, Australia and New Zealand). Data collection spanned September 2015 to December 2022 and included the plans selected online, on Cone-Beam Computed Tomography (CBCT) data. Concordance with the plans selected offline by the independent RT QA central reviewer was evaluated. RESULTS: Analysable data was received for 72 participants, giving a total of 884 CBCTs. The overall concordance rate was 83% (723/884). From stage 1 to stage 2 the concordance in the plans selected improved from 75% (369/495) to 91% (354/389). CONCLUSION: During-accrual IGRT QA positively influenced plan selection concordance, highlighting the need for ongoing support when introducing a new technique. Overall, it contributes to advancing the understanding and implementation of QA measures in adaptive radiotherapy trials.

Dietary fat quality, plasma atherogenic lipoproteins, and atherosclerotic cardiovascular disease: An overview of the rationale for dietary recommendations for fat intake.

The scientific evidence supporting the current dietary recommendations for fat quality keeps accumulating; however, a paradoxical distrust has taken root among many researchers, clinicians, and in parts of the general public. One explanation for this distrust may relate to an incomplete overview of the totality of the evidence for the link between fat quality as a dietary exposure, and health outcomes such as atherosclerotic cardiovascular disease (ASCVD). Therefore, the main aim of the present narrative review was to provide a comprehensive overview of the rationale for dietary recommendations for fat intake, limiting our discussion to ASCVD as outcome. Herein, we provide a core framework - a causal model - that can help us understand the evidence that has accumulated to date, and that can help us understand new evidence that may become available in the future. The causal model for fat quality and ASCVD is comprised of three key research questions (RQs), each of which determine which scientific methods are most appropriate to use, and thereby which lines of evidence that should feed into the causal model. First, we discuss the link between low-density lipoprotein (LDL) particles and ASCVD (RQ1); we draw especially on evidence from genetic studies, randomized controlled trials (RCTs), epidemiology, and mechanistic studies. Second, we explain the link between dietary fat quality and LDL particles (RQ2); we draw especially on metabolic ward studies, controlled trials (randomized and non-randomized), and mechanistic studies. Third, we explain the link between dietary fat quality, LDL particles, and ASCVD (RQ3); we draw especially on RCTs in animals and humans, epidemiology, population-based changes, and experiments of nature. Additionally, the distrust over dietary recommendations for fat quality may partly relate to an unclear understanding of the scientific method, especially as applied in nutrition research, including the process of developing dietary guidelines. We therefore also aimed to clarify this process. We discuss how we assess causality in nutrition research, and how we progress from scientific evidence to providing dietary recommendations.

Increasing chronic disease preventive care in community mental health services: clinician-generated strategies.

BACKGROUND: People with a mental health condition experience a high prevalence of chronic disease risk behaviours e.g., tobacco smoking and physical inactivity. Recommended 'preventive care' to address these risks is infrequently provided by community mental health services. This study aimed to elucidate, among community mental health managers and clinicians, suggestions for strategies to support provision of preventive care. METHODS: Three qualitative focus groups (n = 14 clinicians) were undertaken in one regional community mental health service to gather perspectives of barriers to preventive care provision, deductively coded against the domains of the Theoretical Domains Framework (TDF). Drawing on the learnings from the focus groups, individual interviews (n = 15 managers and clinicians) were conducted in two services to identify suggestions for strategies to increase preventive care. Strategies were inductively coded and mapped into TDF domains. RESULTS: Barriers were identified across a wide range of TDF domains, most notably knowledge and environmental context and resources. Nine strategies were identified across three themes: training, resources and systems changes; mapping to all 14 TDF domains. CONCLUSION: Future research seeking to increase implementation of preventive care may be guided by these findings. There is need for greater recognition and resourcing of preventive care as a priority and integral component of mental health treatment.

Exploring the design and utility of an integrated web-based chatbot for young adults to support healthy eating: a qualitative study.

BACKGROUND: There is a lack of understanding of the potential utility of a chatbot integrated into a website to support healthy eating among young adults. Therefore, the aim was to interview key informants regarding potential utility and design of a chatbot to: (1) increase young adults' return rates and engagement with a purpose-built healthy eating website and, (2) improve young adults' diet quality. METHODS: Eighteen qualitative, semi-structured interviews were conducted across three stakeholder groups: (i) experts in dietary behaviour change in young adults (n = 6), (ii) young adult users of a healthy eating website (n = 7), and (iii) experts in chatbot design (n = 5). Interview questions were guided by a behaviour change framework and a template analysis was conducted using NVivo. RESULTS: Interviewees identified three potential roles of a chatbot for supporting healthy eating in young adults; R1: improving healthy eating knowledge and facilitating discovery, R2: reducing time barriers related to healthy eating, R3: providing support and social engagement. To support R1, the following features were suggested: F1: chatbot generated recommendations and F2: triage to website information or externally (e.g., another website) to address current user needs. For R2, suggested features included F3: nudge or behavioural prompts at critical moments and F4: assist users to navigate healthy eating websites. Finally, to support R3 interviewees recommended the following features: F5: enhance interactivity, F6: offer useful anonymous support, F7: facilitate user connection with content in meaningful ways and F8: outreach adjuncts to website (e.g., emails). Additional 'general' chatbot features included authenticity, personalisation and effective and strategic development, while the preferred chatbot style and language included tailoring (e.g., age and gender), with a positive and professional tone. Finally, the preferred chatbot message subjects included training (e.g., would you like to see a video to make this recipe?), enablement (e.g., healthy eating doesn't need to be expensive, we've created a budget meal plan, want to see?) and education or informative approaches (e.g., "Did you know bananas are high in potassium which can aid in reducing blood pressure?"). CONCLUSION: Findings can guide chatbot designers and nutrition behaviour change researchers on potential chatbot roles, features, style and language and messaging in order to support healthy eating knowledge and behaviours in young adults.

Clinical experiences with online adaptive radiotherapy of vulvar carcinoma.

BACKGROUND AND PURPOSE: Radiotherapy for vulvar carcinoma is challenging due to relatively high risk of locoregional disease recurrence, a technically challenging target, and postoperative lymphocele, and a high risk radiation sequelae. We aim to explore, if it is possible to reduce dose to normal tissue, while maintaining CTV coverage for this patient group with online adaptive radiotherapy. MATERIALS AND METHODS: 20 patients with vulvar carcinoma (527 fractions) were treated with online adaptation on a Varian Ethos accelerator. Setup CBCTs were acquired daily for adaptive planning. Verification CBCTs were acquired immediately prior to dose delivery. CTV dose coverage and dose to bladder and rectum were extracted from the scheduled and adapted plans as well as from adapted plans recalculated based on verification CBCTs. In addition, analysis of the decision of the adaptive procedure was performed for 17 patients (465 fractions). RESULTS: Mean CTV D95% and standard deviation was 98% ± 5% for the scheduled plan compared to 100.0 ± 0.3% and 100.0 ± 0.8% for the adapted plan on the setup and verification CBCT respectively. Dose to OARs varied substantially and did not show any benefit from adaption itself, however a margin reduction was implemented after the first patients treated. The adapted plan was chosen for 63.5% of the fractions and dominant reasons for not adapting were 'no significant dosimetric gain' (75 fractions, 14%) and 'Medical doctor (MD) not available for treatment' (50 fractions, 9.5%). The median adaption time was 15 min and the 25th and 75th percentile was 12 and 17 min, respectively. CONCLUSION: CTVs and PTVs dose coverage were significantly improved with adaptation compared to image-guided RT. This gain was robust during the treatment time.

Changes in physical activity, diet, sleep, and mental well-being when starting university: A qualitative exploration of Australian student experiences.

Objective: To explore young adult's experiences of how starting university influenced their physical activity, diet, sleep, and mental well-being, and barriers and enablers to health behavior change. Participants: University students aged 18-25 years. Methods: Three focus groups were conducted in November 2019. Inductive thematic approach was utilized to identify themes. Results: Students (female: n = 13, male: n = 2, other gender identity: n = 1, 21.2 (1.6) years) reported mental well-being, physical activity levels, diet quality and sleep health were negatively affected. Stress, study demands, university timetabling, not prioritizing physical activity, cost and availability of healthy foods, and difficulty falling asleep were key barriers. Health behavior change interventions aiming to support mental well-being need to include both information and support features. Conclusions: There is a significant opportunity to improve the transition to university for young adults. Findings highlight areas to target in future interventions to improve physical activity, diet, and sleep of university students.

Experiences with Gluten-Free Bread: A Qualitative Study Amongst People with Coeliac Disease Participating in a Randomised Controlled Trial.

BACKGROUND: Whole-grain bread can be an important source of fibre for people with coeliac disease (CeD) who must adhere to a gluten-free diet and avoid consuming wheat, rye and barley. Gluten-free bread frequently has a lower nutritional quality and different texture relative to gluten-containing counterparts. OBJECTIVE: The aim was to investigate experiences with gluten-free bread amongst people with CeD prior to and during a randomised controlled trial (RCT). DESIGN: We conducted individual interviews with 10 people with CeD participating in a RCT that aimed to investigate the effects of fibre-rich gluten-free products on metabolic regulation in people with CeD compared with benchmark gluten-free products. Five participants were in the control group (benchmark gluten-free bread) and five participants in the intervention group (fibre-rich gluten-free bread). The fibre-rich gluten free bread was formulated and prepared by the project group. The benchmark gluten-free bread was commercially available. The RCT lasted for four weeks. Interviews were conducted digitally between October 2021 and January 2022 and were thematically analysed. RESULTS: Participants in both groups appeared to avoid bread prior to the study, primarily due to the poor taste and chewy consistency of the available bread in food stores and bakeries. Participants preferred the fibre-rich intervention bread as opposed to the available bread in the food market. However, participants had to become accustomed to eating the fibre-rich whole-grain bread during the study, since they avoided eating store-bought bread that they experienced chewy and not filling. CONCLUSIONS: Participants asked for fibre-rich gluten-free bread products that are satiating and have a good texture. Palatable gluten-free bread products might be an important source of fibre for people with CeD.

Glycated Proteins, Glycine, Acetate, and Monounsaturated Fatty Acids May Act as New Biomarkers to Predict the Progression of Type 2 Diabetes: Secondary Analyses of a Randomized Controlled Trial.

Food protein or food-derived peptides may regulate blood glucose levels; however, studies have shown inconsistent results. The aim of the present study was to characterize subgroups of individuals with increased risk of type 2 diabetes (T2D) and to investigate the cardiometabolic effects of fish protein in the same subgroups. We first divided participants into high insuliniAUC and low insuliniAUC subjects based on their insulin incremental area under the curve (iAUC) levels after a 2 h oral glucose tolerance test (OGTT), and secondly based on whether they had received 5.2 g salmon fish protein or placebo for 8 weeks, in a previously conducted randomized controlled trial (RCT). We then profiled these groups by analyzing plasma metabolomics and peripheral blood mononuclear cell (PBMC) gene expression. Compared to the low insuliniAUC group, the high insuliniAUC group had higher plasma concentrations of monounsaturated fatty acids (MUFAs) and glycated proteins (GlycA) and lower concentrations of glycine and acetate. After intervention with fish protein compared to placebo, however, only acetate was significantly increased in the low insuliniAUC group. In conclusion, we identified metabolic biomarkers known to be associated with T2D; also, intervention with fish protein did not affect cardiometabolic risk markers in subgroups with increased risk of T2D.

Attitudes towards and experiences with sourdough and baker's yeast bread amongst participants in a randomised controlled trial: a qualitative study.

Background: Bread is an important source of dietary fibre. However, an increasing number of individuals exclude bread from their habitual diet for various reasons. In recent years, sourdough bread has increased in popularity, and clinical studies have indicated that sourdough bread may decrease gastrointestinal symptoms. Objective: To investigate attitudes towards and experiences with sourdough and baker's yeast bread amongst participants in a randomised controlled trial (RCT), the health effects and consumer aspects of bread (HELFAB) study. Design: We conducted individual interviews with 10 participants who stated to be sceptical about bread and who participated in an RCT to investigate the health effects of sourdough bread versus baker's yeast bread. The participants were interviewed on two occasions (before and after the RCT). Interviews were conducted digitally between September and December 2020 and were thematically analysed. Results: Half of the interviewed participants experienced gastrointestinal symptoms, such as pain in the stomach, when they consumed bread prior to the RCT. They often preferred sourdough bread to baker's yeast bread both before and after the study, since they found that sourdough bread was easier to digest. Participants who were sceptical about bread prior to the study became more positive about bread because of their experiences with the intervention breads. This finding was mainly related to the taste and consistency of sourdough bread. The participants often associated bread with healthiness, mainly due to the dietary fibre content in bread. Conclusions: Sourdough bread with increased dietary fibre may be an important source of dietary fibre for those who perceive gastrointestinal problems from baker's yeast bread. Participants in this qualitative study stated to change their attitudes towards bread, mainly due to perceived healthiness of the intervention bread.

Replacing saturated fatty acids with polyunsaturated fatty acids increases the abundance of Lachnospiraceae and is associated with reduced total cholesterol levels-a randomized controlled trial in healthy individuals.

BACKGROUND: Improving dietary fat quality strongly affects serum cholesterol levels and hence the risk of cardiovascular diseases (CVDs). Recent studies have identified dietary fat as a potential modulator of the gut microbiota, a central regulator of host metabolism including lipid metabolism. We have previously shown a significant reduction in total cholesterol levels after replacing saturated fatty acids (SFAs) with polyunsaturated fatty acids (PUFAs). The aim of the present study was to investigate the effect of dietary fat quality on gut microbiota, short-chain fatty acids (SCFAs), and bile acids in healthy individuals. In addition, to investigate how changes in gut microbiota correlate with blood lipids, bile acids, and fatty acids. METHODS: Seventeen participants completed a randomized, controlled dietary crossover study. The participants received products with SFAs (control) or PUFAs in random order for three days. Fecal samples for gut microbiota analyses and fasting blood samples (lipids, fatty acids, and bile acids) were measured before and after the three-day intervention. RESULTS: Of a panel of 40 bacteria, Lachnospiraceae and Bifidobacterium spp. were significantly increased after intervention with PUFAs compared with SFAs. Interestingly, changes in Lachnospiraceae, as well as Phascolarlactobacterium sp. and Eubacterium hallii, was also found to be negatively correlated with changes in total cholesterol levels after replacing the intake of SFAs with PUFAs for three days. No significant differences in SCFAs or bile acids were found after the intervention. CONCLUSION: Replacing SFAs with PUFAs increased the abundance of the gut microbiota family of Lachnospiraceae and Bifidobacterium spp. Furthermore, the reduction in total cholesterol after improving dietary fat quality correlated with changes in the gut microbiota family Lachnospiraceae. Future studies are needed to reveal whether Lachnospiraceae may be targeted to reduce total cholesterol levels. TRIAL REGISTRATION: The study was registered at Clinical Trials ( https://clinicaltrials.gov/ , registration identification number: NCT03658681).

Gut microbiota is associated with dietary intake and metabolic markers in healthy individuals.

Background: Metabolic diseases have been related to gut microbiota, and new knowledge indicates that diet impacts host metabolism through the gut microbiota. Identifying specific gut bacteria associated with both diet and metabolic risk markers may be a potential strategy for future dietary disease prevention. However, studies investigating the association between the gut microbiota, diet, and metabolic markers in healthy individuals are scarce. Objective: We explored the relationship between a panel of gut bacteria, dietary intake, and metabolic and anthropometric markers in healthy adults. Design: Forty-nine volunteers were included in this cross-sectional study. Measures of glucose, serum triglyceride, total cholesterol, hemoglobin A1c (HbA1c), blood pressure (BP), and body mass index (BMI) were collected after an overnight fast, in addition to fecal samples for gut microbiota analyzes using a targeted approach with a panel of 48 bacterial DNA probes and assessment of dietary intake by a Food Frequency Questionnaire (FFQ). Correlations between gut bacteria, dietary intake, and metabolic and anthropometric markers were assessed by Pearson's correlation. Gut bacteria varying according to dietary intake and metabolic markers were assessed by a linear regression model and adjusted for age, sex, and BMI. Results: Of the 48 gut bacteria measured, 24 and 16 bacteria correlated significantly with dietary intake and metabolic and/or anthropometric markers, respectively. Gut bacteria including Alistipes, Lactobacillus spp., and Bacteroides stercoris differed according to the intake of the food components, fiber, sodium, saturated fatty acids, and dietary indices, and metabolic markers (BP and total cholesterol) after adjustments. Notably, Bacteroides stercoris correlated positively with the intake of fiber, grain products, and vegetables, and higher Bacteroides stercoris abundance was associated with higher adherence to Healthy Nordic Food Index (HNFI) and lower diastolic BP after adjustment. Conclusion: Our findings highlight the relationship between the gut microbiota, diet, and metabolic markers in healthy individuals. Further investigations are needed to address whether these findings are causally linked and whether targeting these gut bacteria can prevent metabolic diseases.

A Three-Day Intervention With Granola Containing Cereal Beta-Glucan Improves Glycemic Response and Changes the Gut Microbiota in Healthy Individuals: A Crossover Study.

Intake of soluble fibers including beta-glucan, is known to improve post-prandial glycemic response. The mechanisms have been attributed to the viscous gel forming in the stomach and small intestine, giving a longer absorption time. However, recent evidence suggests a link between intake of beta-glucan and improved glycemic regulation at subsequent meals through the gut microbiota. We investigated the short-term effect of granola with different amounts of cereal beta-glucan on glycemic response and gut microbiota. After a two-week run-in period (baseline), fourteen healthy, normal weight adults completed a dose-response dietary crossover study. Different amounts of cereal beta-glucan (low: 0.8 g, medium: 3.2 g and high: 6.6 g) were provided in granola and eaten with 200 ml low-fat milk as an evening meal for three consecutive days. Blood glucose and insulin were measured fasted and after an oral glucose tolerance test (OGTT) the following day, in addition to peptide YY (PYY) and glucagon-like peptide (GLP-2), fasting short chain fatty acids (SCFA) in blood, breath H2, and gut microbiota in feces. Only the intervention with medium amounts of beta-glucan decreased blood glucose and insulin during OGTT compared to baseline. Fasting PYY increased with both medium and high beta-glucan meal compared to the low beta-glucan meal. The microbiota and SCFAs changed after all three interventions compared to baseline, where acetate and butyrate increased, while propionate was unchanged. Highest positive effect size after intake of beta-glucan was found with Haemophilus, followed by Veillonella and Sutterella. Furthermore, we found several correlations between different bacterial taxa and markers of glycemic response. In summary, intake of granola containing 3.2 g cereal beta-glucan as an evening meal for three consecutive days reduced the glycemic response after an OGTT 0-180 min and changed gut microbiota composition. Since we cannot rule out that other fiber types have contributed to the effect, more studies are needed to further explore the effect of cereal beta-glucan on glycemic regulation. Clinical Trial Registration: [www.clinicaltrials.gov], identifier [NCT03293693].

Recognising the challenges of implementing multi-centre adaptive plan of the day radiotherapy.

Two multicentre adaptive radiotherapy trials utilising Plan of the Day (PoD) with a library of plans were introduced in 35 centres. The common issues that arose from all centres when introducing PoD were collated retrospectively, through reviewing the data pertaining to the pre-trial and on-trial quality assurance programme. It was found that 1,295 issues arose when introducing PoD in outlining, planning, treatment delivery i.e., PoD selection, and in the overall process of delivering PoD. There was no difference in the number of issues that arose from pre-trial to on-trial. Thus, it is recommended that the implementation of PoD is supported by guidance, reviews, and continuous monitoring.

A Qualitative Study Exploring People's Experience With the Multicomponent Community-Based Physical Activity Intervention ecofit During the COVID-19 Pandemic.

BACKGROUND: The COVID-19 global pandemic greatly impacted lifestyles and physical activity routines. This study explored how the COVID-19 pandemic impacted participant experience and motivation in ecofit, a large, community-based, multicomponent intervention that supports aerobic and resistance-based physical activity using publicly available, outdoor exercise facilities and smartphone technology. METHODS: Fifteen participants from the intervention arm of the study were interviewed. Audiotaped telephone interviews were transcribed verbatim and analyzed by a researcher uninvolved in the intervention. Through an inductive thematic approach, data were coded and organized into themes. The quantitative measure of participant smartphone application engagement was used as a classification during analysis. RESULTS: Several themes representing participants' experience of the COVID-19 pandemic in their engagement with ecofit, overall physical activity levels, motivation to exercise, and perception and usage of outdoor gym facilities were identified. CONCLUSION: The impact of the COVID-19 pandemic on clinical trials is beginning to emerge. Although the present study showed a mixed impact of the pandemic on participation in the ecofit program, the overall implications for the intervention are yet to be determined. Interestingly, although a large review found a negative impact of COVID-19 on physical activity, this sample reported an overall increase.

Changes in antidepressant medication use in the workplace and sustainable employability: a qualitative study of experiences, strategies and solutions.

This study explores patients' experiences of how antidepressant medication transition events (ceasing, changing or reducing) affect employment and workplace functioning. An anonymous online survey was conducted with adults who had experienced antidepressant medication transition events (AMTEs). Data were analyzed using a hybrid inductive and deductive thematic analysis approach. While a majority of participants perceived many positive impacts of antidepressant medication on their workplace functioning, considerable negative effects during AMTEs were reported. Participants provided practical solutions to assist employers, policy and clinicians. Significant and detrimental impact of antidepressant medication changes occurred in the workplace. There is an urgent need to raise awareness of the vulnerability of people during AMTEs and to develop educational and supportive resources to assist clinicians and practitioners to support people during this vulnerable time.

Men's Perceptions of a Gender-Tailored eHealth Program Targeting Physical and Mental Health: Qualitative Findings from the SHED-IT Recharge Trial.

Despite increasing rates of co-morbid depression and obesity, few interventions target both conditions simultaneously, particularly in men. The SHED-IT: Recharge trial, conducted in 125 men with depressive symptoms and overweight or obesity, tested the efficacy of a gender-tailored eHealth program with integrated mental health support. The aims of this study were to examine the perceptions of men who received the SHED-IT: Recharge intervention in relation to recruitment, satisfaction with the program, and suggestions to improve the program. Individual semi-structured interviews were conducted in a random sub-sample, stratified by baseline depression and weight status (n = 19, mean (SD) age 49.6 years (11.6), PHQ-9 score 9.0 (3.7), BMI 32.5 kg/m2 (4.6)). Transcripts were analyzed using an inductive process by an independent qualitative researcher. Four themes emerged, namely, (i) specific circumstances determined men's motivation to enroll, (ii) unique opportunity to implement sustained physical and mental health changes compared to previous experiences, (iii) salience of the program elements, and (iv) further opportunities that build accountability could help maintain focus. Gender-tailored, self-directed lifestyle interventions incorporating mental health support are acceptable and satisfying for men experiencing depressive symptoms. These findings provide important insights for future self-guided lifestyle interventions for men with poor physical and mental health.

Facilitators of and barriers to collaboration between universities and the food industry in nutrition research: a qualitative study.

BACKGROUND: Unhealthy food is one of the main risk factors for non-communicable diseases. Improved knowledge about healthy and sustainable food products requires nutrition research in collaboration between universities and the food industry. OBJECTIVE: To investigate the facilitators of and barriers to university-industry collaborations in nutrition research. DESIGN: Semi-structured, individual interviews with five researchers in universities and five employees in the food industry were conducted in the Oslo region, Norway. Interviews were thematically analysed and guided by Braun and Clark. RESULTS: This study showed positive experiences and attitudes towards a university-industry collaboration within nutrition research aiming for healthier food products. The main facilitators of good collaboration were common goals, the exchange of knowledge and the opportunity for research funding. Barriers to good collaboration were prejudices related to the food industry's goals and previous experiences of time-consuming projects. Interestingly, collaboration agreements were identified as both facilitators of and barriers to good collaboration. CONCLUSION: Stimulating university-food industry collaboration requires increased juridical assistance, provided that the lawyers involved understand the parties' interests and the need to balance those interests and safeguard mutual trust. In addition, the food industry must take a clearer role in their engagement in public health to improve their trustworthiness in relation to research results.

Replacing Saturated Fat with Polyunsaturated Fat Modulates Peripheral Blood Mononuclear Cell Gene Expression and Pathways Related to Cardiovascular Disease Risk Using a Whole Transcriptome Approach.

SCOPE: The aim of this study is to explore the molecular mechanisms underlying the effect of replacing dietary saturated fat (SFA) with polyunsaturated fat (PUFA) on cardiovascular disease (CVD) risk using a whole transcriptome approach. METHODS AND RESULTS: Healthy subjects with moderate hypercholesterolemia (n = 115) are randomly assigned to a control diet (C-diet) group or an experimental diet (Ex-diet) group receiving comparable food items with different fatty acid composition for 8 weeks. RNA isolated from peripheral blood mononuclear cells (PBMCs) at baseline and after 8 weeks of intervention is analyzed by microarray technology (n = 95). By use of a linear regression model (n = 92), 14 gene transcripts are differentially altered in the Ex-diet group compared to the C-diet group. These include transcripts related to vascular smooth muscle cell proliferation, low-density lipoprotein receptor folding, and regulation of blood pressure. Furthermore, pathways mainly related to immune response and inflammation, signal transduction, development, and cytoskeleton remodeling, gene expression and protein function, are differentially enriched between the groups. CONCLUSION: Replacing dietary SFA with PUFA for 8 weeks modulates PBMC gene expression and pathways related to CVD risk in healthy subjects with moderate hypercholesterolemia.