The effect of increased fruit and vegetable consumption on blood pressure and lipids: a pooled analysis of six randomised controlled fruit and vegetable intervention trials.

BACKGROUND: Increasing fruit and vegetable (FV) consumption is associated with reduced cardiovascular disease risk in observational studies but with little evidence from randomised controlled trials (RCTs). The impact of concurrent pharmacological therapy is unknown. OBJECTIVE: To pool data from six RCTs to examine the effect of increasing FV intake on blood pressure (BP) and lipid profile, also exploring whether effects differed by medication use. DESIGN: Across trials, dietary intake was assessed by diet diaries or histories, lipids by routine biochemical methods and BP by automated monitors. Linear regression provided an estimate of the change in lipid profile or BP associated with a one portion increase in self-reported daily FV intake, with interaction terms fitted for medication use. RESULTS: The pooled sample included a total of 554 participants (308 males and 246 females). Meta-analysis of regression coefficients revealed no significant change in either systolic or diastolic BP per portion FV increase, although there was significant heterogeneity across trials for systolic BP (I2 = 73%). Neither adjusting for change in body mass index, nor analysis according to use of anti-hypertensive medication altered the relationship. There was no significant change in lipid profile per portion FV increase, although there was a significant reduction in total cholesterol among those not on lipid-lowering therapy (P < 0.05 after Bonferroni correction). CONCLUSION: Pooled analysis of six individual FV trials showed no impact of increasing intake on BP or lipids, but there was a total cholesterol-lowering effect in those not on lipid-lowering therapy.

Understanding engagement in diet and dementia prevention research among British South Asians: a short report of findings from a patient and public involvement group.

BACKGROUND: Dementia is a global public health challenge. Evidence suggests that individuals from South Asian communities are an at-risk group for dementia, partly as a result of early and cumulative exposure to known dementia risk factors, such as obesity and type 2 diabetes. There needs to be more culturally appropriate community engagement to increase awareness of dementia and identify better strategies to encourage participation in dementia-related research. METHODS: We aimed to better understand the barriers and facilitators towards engaging with, and participating in, diet and dementia related research among British South Asians. This was achieved using a public and patient involvement (PPI) approach. A community-based, engagement event involving information sharing from experts and roundtable discussions with South Asian communities (n = 26 contributors) was held in June 2023 in Newcastle-upon-Tyne, UK. Collaboration from preidentified PPI representatives (n = 3) informed the content and structure of PPI activities, as well as recruitment. Data were synthesised using template analysis, a form of codebook thematic analysis. This involved deductively analysing data using relevant a priori themes, which were expanded upon, or modified, via inductive analysis. RESULTS: The findings highlighted the importance of trust, representation and appreciation of cultural barriers as facilitators to engagement in diet and dementia risk reduction research. Consideration of language barriers, time constraints, social influences and how to embed community outreach activities were reported as driving factors to maximise participation. CONCLUSIONS: This PPI work will inform the design and co-creation of a culturally adapted dietary intervention for brain health in accordance with the Medical Research Council and National Institute for Health and Care Research guidance for developing complex interventions.

Mediterranean diet adherence is associated with lower dementia risk, independent of genetic predisposition: findings from the UK Biobank prospective cohort study.

BACKGROUND: The identification of effective dementia prevention strategies is a major public health priority, due to the enormous and growing societal cost of this condition. Consumption of a Mediterranean diet (MedDiet) has been proposed to reduce dementia risk. However, current evidence is inconclusive and is typically derived from small cohorts with limited dementia cases. Additionally, few studies have explored the interaction between diet and genetic risk of dementia. METHODS: We used Cox proportional hazard regression models to explore the associations between MedDiet adherence, defined using two different scores (Mediterranean Diet Adherence Screener [MEDAS] continuous and Mediterranean diet Pyramid [PYRAMID] scores), and incident all-cause dementia risk in 60,298 participants from UK Biobank, followed for an average 9.1 years. The interaction between diet and polygenic risk for dementia was also tested. RESULTS: Higher MedDiet adherence was associated with lower dementia risk (MEDAS continuous: HR = 0.77, 95% CI = 0.65-0.91; PYRAMID: HR = 0.86, 95% CI = 0.73-1.02 for highest versus lowest tertiles). There was no significant interaction between MedDiet adherence defined by the MEDAS continuous and PYRAMID scores and polygenic risk for dementia. CONCLUSIONS: Higher adherence to a MedDiet was associated with lower dementia risk, independent of genetic risk, underlining the importance of diet in dementia prevention interventions.

Behaviour Change Techniques in Computerized Cognitive Training for Cognitively Healthy Older Adults: A Systematic Review.

We aimed to describe behaviour change techniques (BCT) used in trials evaluating computerised cognitive training (CCT) in cognitively healthy older adults, and explore whether BCTs are associated with improved adherence and efficacy. The 90 papers included in a recent meta-analysis were reviewed for information about adherence and use of BCTs in accordance with the Behaviour Change Taxonomy. Studies using a specific BCT were compared with studies not using that BCT on efficacy (difference in Hedges' g [Δg]) using three level meta-regression models and on median adherence using the Wilcoxon test. The median number of BCTs per study was 3 (interquartile range [IQR] = 2-5). 'Feedback on behaviour' (if provided by a person; Δg = -0.19, 95% confidence interval [CI] = -0.31;-0.07) and 'non-specific reward' (Δg = -0.19, CI = -0.34;-0.05) were associated with lower efficacy. Certain BCTs that involve personal contact may be beneficial, although none were statistically significantly associated with greater efficacy. The median percentage of adherence was 90% (IQR = 81-95). Adherence was higher in studies using the BCT 'self-monitoring of behaviour' and lower in studies using the BCT 'graded tasks' than studies not using these BCTs (p < 0.001). These findings provide first evidence that BCTs can influence both adherence to and efficacy of CCT programs in cognitively healthy older adults.

A qualitative study to inform adaptations to a brain health intervention for older adults with type 2 diabetes living in rural regions of Ireland.

AIMS: Type 2 diabetes is a risk factor for late-life dementia, but dementia prevention strategies have yet to be comprehensively evaluated in people with diabetes. The Finnish Geriatric Intervention Study to Prevent Cognitive Impairment and Disability (FINGER) demonstrated cognitive benefits of a 2-year multidomain lifestyle intervention. However, given the intensive nature of FINGER, there is uncertainty about whether it can be implemented in other high-risk populations. Our aim was to explore attitudes towards dementia risk, and barriers to an intervention based on the FINGER model in older adults with type 2 diabetes living in rural areas of Ireland. METHODS: Focus groups were conducted with 21 adults (11 men and 10 women) aged 60+ years with type 2 diabetes living in border regions of north and south Ireland. Data were analysed using thematic analysis. RESULTS: There was limited understanding of diabetes as a risk factor for late-life dementia. The main barriers to engagement with the multidomain intervention were eating foods that were not compatible with cultural norms, time and travel constraints, and perceived lack of self-efficacy and self-motivation for adopting the desired diet, exercise and computerised cognitive training (CCT) behaviours. Facilitators for intervention acceptability included the provision of culturally tailored and personalised education, support from a trusted source, and inclusion of goal setting and self-monitoring behavioural strategies. CONCLUSIONS: While there was high acceptability for a brain health intervention, several barriers including cultural food norms and low self-efficacy for adopting the diet, exercise and CCT components would need to be considered in the intervention design. Findings from this study will be used to inform local decisions regarding the adaptation of FINGER for people with type 2 diabetes. The feasibility of the adapted multidomain intervention will then be evaluated in a future pilot trial.

The compatibility of oxytocin and tranexamic acid injection products when mixed for co-administration by infusion for the treatment of postpartum haemorrhage: An in vitro investigation.

OBJECTIVE: To investigate the compatibility of oxytocin and tranexamic acid injection products when mixed for the purpose of co-administration by intravenous infusion. DESIGN: Compatibility testing. SETTING: Hospitals taking part in a multicentre postpartum haemorrhage treatment (E-MOTIVE) trial in Kenya, Nigeria, Tanzania and South Africa. SAMPLE: Oxytocin and tranexamic acid products. METHODS: The compatibility of two sentinel products of oxytocin injection and tranexamic acid injection in 200-mL infusion bags of both 0.9% w/v saline and Ringer's lactate solution was assessed. We analysed all tranexamic acid-oxytocin combinations, and each evaluation was conducted for up to 3 h. Subsequently, the compatibility of multiple tranexamic acid products with reference oxytocin products when mixed in 0.9% w/v saline over a period of 1 h was investigated. MAIN OUTCOME MEASURES: Concentration of oxytocin over time after mixing with tranexamic acid products. RESULTS: We found significant interaction between certain oxytocin and tranexamic acid products after mixing them in vitro and observing for 1 h. The interaction substantially impacted oxytocin content leading to reduction in concentration (14.8%-29.0%) immediately on mixing (t = 0 min). In some combinations, the concentration continued to decline throughout the stability assessment period. Oxytocin loss was observed in 7 out of 22 (32%) of combinations tested. CONCLUSIONS: In a clinical setting, mixing certain oxytocin and tranexamic acid products before administration may result in an underdosing of oxytocin, compromising care in an emergency life-threatening situation. The mixing of oxytocin and tranexamic acid injection products for co-administration with intravenous infusion fluids should be avoided until the exact nature of the observed interaction and its implications are understood.

Food insecurity and brain health in adults: A systematic review.

Food insecurity has been associated with adverse effects on physical health and well-being in both high and low-income countries, but effects on brain health are not clear. The purpose of this systematic review was to determine the relationship between food insecurity and important brain health outcomes in adults including depression, stroke, cognitive impairment and dementia. Electronic databases were searched to find studies which investigated relations between food insecurity and predefined brain health outcomes. Thirty studies met the inclusion criteria for review of which 23 were conducted in high income countries and seven in low- or middle-income countries. Most studies (n = 24) were cross-sectional, five were prospective and 1 was a case-control design. Seven studies reporting outcomes relating to cognitive performance and 24 relating to depression. No studies investigated relations between food insecurity and stroke or dementia. There was substantial heterogeneity in the populations studied as well as measures of food insecurity and outcomes which made comparisons between studies difficult. Overall, the findings highlighted that individuals who were food insecure had increased likelihood of depressive symptoms and poorer global cognition than those who were food secure. It is possible that social support and food aid programmes attenuate the effects of food insecurity on depressive symptoms. Future research is needed to determine whether interventions to alleviate food insecurity can benefit brain health in vulnerable populations.

The feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet in established community groups at increased CVD risk: the TEAM-MED EXTEND study: a pilot cluster randomised controlled trial.

This study aimed to evaluate the feasibility of a peer support intervention to encourage adoption and maintenance of a Mediterranean diet (MD) in established community groups where existing social support may assist the behaviour change process. Four established community groups with members at increased Cardiovascular Disease (CVD) risk and homogenous in gender were recruited and randomised to receive either a 12-month Peer Support (PS) intervention (PSG) (n 2) or a Minimal Support intervention (educational materials only) (MSG) (n 2). The feasibility of the intervention was assessed using recruitment and retention rates, assessing the variability of outcome measures (primary outcome: adoption of an MD at 6 months (using a Mediterranean Diet Score (MDS)) and process evaluation measures including qualitative interviews. Recruitment rates for community groups (n 4/8), participants (n 31/51) and peer supporters (n 6/14) were 50 %, 61 % and 43 %, respectively. The recruitment strategy faced several challenges with recruitment and retention of participants, leading to a smaller sample than intended. At 12 months, a 65 % and 76·5 % retention rate for PSG and MSG participants was observed, respectively. A > 2-point increase in MDS was observed in both the PSG and the MSG at 6 months, maintained at 12 months. An increase in MD adherence was evident in both groups during follow-up; however, the challenges faced in recruitment and retention suggest a definitive study of the peer support intervention using current methods is not feasible and refinement based on the current feasibility study should be incorporated. Lessons learned during the implementation of this intervention will help inform future interventions in this area.

Trial to Encourage Adoption and Maintenance of a MEditerranean Diet (TEAM-MED): a randomised pilot trial of a peer support intervention for dietary behaviour change in adults from a Northern European population at high CVD risk.

Adhering to a Mediterranean diet (MD) is associated with reduced CVD risk. This study aimed to explore methods of increasing MD adoption in a non-Mediterranean population at high risk of CVD, including assessing the feasibility of a developed peer support intervention. The Trial to Encourage Adoption and Maintenance of a MEditerranean Diet was a 12-month pilot parallel group RCT involving individuals aged ≥ 40 year, with low MD adherence, who were overweight, and had an estimated CVD risk ≥ 20 % over ten years. It explored three interventions, a peer support group, a dietician-led support group and a minimal support group to encourage dietary behaviour change and monitored variability in Mediterranean Diet Score (MDS) over time and between the intervention groups, alongside measurement of markers of nutritional status and cardiovascular risk. 118 individuals were assessed for eligibility, and 75 (64 %) were eligible. After 12 months, there was a retention rate of 69 % (peer support group 59 %; DSG 88 %; MSG 63 %). For all participants, increases in MDS were observed over 12 months (P < 0·001), both in original MDS data and when imputed data were used. Improvements in BMI, HbA1c levels, systolic and diastolic blood pressure in the population as a whole. This pilot study has demonstrated that a non-Mediterranean adult population at high CVD risk can make dietary behaviour change over a 12-month period towards an MD. The study also highlights the feasibility of a peer support intervention to encourage MD behaviour change amongst this population group and will inform a definitive trial.

The effectiveness of peer-supported interventions for encouraging dietary behaviour change in adults: a systematic review.

OBJECTIVE: There is an urgent need to find effective methods of supporting individuals to make dietary behaviour changes. Peer-supported interventions (PSI) have been suggested as a cost-effective strategy to support chronic disease self-management. However, the effect of PSI on dietary behaviour is unclear. The present systematic review aimed to assess the effectiveness of PSI for encouraging dietary behaviour change in adults and to consider intervention characteristics linked with effectiveness. DESIGN: Electronic databases were searched until June 2018 for randomised controlled trials assessing the effectiveness of PSI compared with an alternative intervention and/or control on a dietary related outcome in adults. Following title and abstract screening, two reviewers independently screened full texts and data were extracted by one reviewer and independently checked by another. Results were synthesised narratively. SETTING: Randomised controlled trials.ParticipantsAdult studies. RESULTS: The fifty-four included studies varied in participants, intervention details and results. More PSI reported a positive or mixed effect on diet than no effect. Most interventions used a group model and were lay-led by peer supporters. Several studies did not report intervention intensity, fidelity and peer training and support in detail. Studies reporting positive effects employed more behaviour change techniques (BCT) than studies reporting no effect; however, heterogeneity between studies was considerable. CONCLUSIONS: As evidence was mixed, further interventions need to assess the effect of PSI on dietary behaviour, describe intervention content (theoretical basis, BCT, intensity and peer training/support) and include a detailed process evaluation.

Diet Quality Indices and Leukocyte Telomere Length Among Healthy US Adults: Data From the National Health and Nutrition Examination Survey, 1999-2002.

Aging is the biggest risk factor for the development of chronic diseases. Telomere length may represent one important mechanism by which dietary intake influences risk of age-related diseases; however, it is unknown which diet pattern is most strongly related to telomere length. We compared the relationships between 4 evidence-based diet quality indices and leukocyte telomere length in a nationally representative sample of healthy adults, and the extent to which these associations differed between men and women. Data on 4,758 adults aged 20-65 years with no prior diagnosis of major chronic disease were obtained from the 1999-2002 cycles of the National Health and Nutrition Examination Survey. Diet was assessed using one 24-hour dietary recall. After adjustment for sociodemographic and health characteristics, comparison of the top and bottom quintiles showed that higher Healthy Eating Index 2010 scores (ß = 0.065, 95% confidence interval (CI): 0.018, 0.112; P-trend = 0.007), Alternate Healthy Eating Index 2010 scores (ß = 0.054, 95% CI: 0.010, 0.097; P-trend = 0.007), Mediterranean Diet scores (ß = 0.058, 95% CI: 0.017, 0.098; P-trend = 0.008), and Dietary Approaches to Stop Hypertension (DASH) scores (ß = 0.052, 95% CI: 0.014, 0.090; P-trend = 0.007) were each associated with longer telomere length in women. These results may provide insight into the complex associations between optimal nutrition and longevity. Further investigation is needed to understand why associations were not observed in men.

Effect of dietary interventions in mild cognitive impairment: a systematic review.

Diet has been investigated in relation to its ability to promote cognitive function. However, evidence is currently limited and has rarely been systematically reviewed, particularly in a mild cognitive impairment (MCI) population. This review examined the effect of diet on cognitive outcomes in MCI patients. A total of five databases were searched to find randomised controlled trial (RCT) studies, with diet as the main focus, in MCI participants. The primary outcome was incident dementia and/or Alzheimer's disease (AD) and secondary outcomes included cognitive function across different domains using validated neuropsychological tests. Sixteen studies met the inclusion criteria. There was a high degree of heterogeneity relating to the nature of the dietary intervention and cognitive outcomes measured, thus making study comparisons difficult. Supplementation with vitamin E (one study, n 516), ginkgo biloba (one study, n 482) or Fortasyn Connect (one study, n 311) had no significant effect on progression from MCI to dementia and/or AD. For cognitive function, the findings showed some improvements in performance, particularly in memory, with the most consistent results shown by B vitamins, including folic acid (one study, n 266), folic acid alone (one study, n 180), DHA and EPA (two studies, n 36 and n 86), DHA (one study, n 240) and flavonol supplementation (one study, n 90). The findings indicate that dietary factors may have a potential benefit for cognitive function in MCI patients. Further well-designed trials are needed, with standardised and robust measures of cognition to investigate the influence of diet on cognitive status.

A qualitative analysis exploring preferred methods of peer support to encourage adherence to a Mediterranean diet in a Northern European population at high risk of cardiovascular disease.

BACKGROUND: Epidemiological and randomised controlled trial evidence demonstrates that adherence to a Mediterranean diet (MD) can reduce cardiovascular disease (CVD) risk. However, methods used to support dietary change have been intensive and expensive. Peer support has been suggested as a possible cost-effective method to encourage adherence to a MD in at risk populations, although development of such a programme has not been explored. The purpose of this study was to use mixed-methods to determine the preferred peer support approach to encourage adherence to a MD. METHODS: Qualitative (focus groups) and quantitative methods (questionnaire and preference scoring sheet) were used to determine preferred methods of peer support. Sixty-seven high CVD risk participants took part in 12 focus groups (60% female, mean age 64 years) and completed a questionnaire and preference scoring sheet. Focus group data were transcribed and thematically analysed. RESULTS: The mean preference score (1 being most preferred and 5 being least preferred) for group support was 1.5, compared to 3.4 for peer mentorship, 4.0 for telephone peer support and 4.0 for internet peer support. Three key themes were identified from the transcripts: 1. Components of an effective peer support group: discussions around group peer support were predominantly positive. It was suggested that an effective group develops from people who consider themselves similar to each other meeting face-to-face, leading to the development of a group identity that embraces trust and honesty. 2. Catalysing Motivation: participants discussed that a group peer support model could facilitate interpersonal motivations including encouragement, competitiveness and accountability. 3. Stepping Stones of Change: participants conceptualised change as a process, and discussed that, throughout the process, different models of peer support might be more or less useful. CONCLUSION: A group-based approach was the preferred method of peer support to encourage a population at high risk of CVD to adhere to a MD. This finding should be recognised in the development of interventions to encourage adoption of a MD in a Northern European population.

Development of a peer support intervention to encourage dietary behaviour change towards a Mediterranean diet in adults at high cardiovascular risk.

BACKGROUND: Mediterranean diet (MD) interventions are demonstrated to significantly reduce cardiovascular disease (CVD) risk but are typically resource intensive and delivered by health professionals. There is considerable interest to develop interventions that target sustained dietary behaviour change and that are feasible to scale-up for wider public health benefit. The aim of this paper is to describe the process used to develop a peer support intervention to encourage dietary behaviour change towards a MD in non-Mediterranean adults at high CVD risk. METHODS: The Medical Research Council (MRC) and Behaviour Change Wheel (BCW) frameworks and the COM-B (Capability, Opportunity, Motivation, Behaviour) theoretical model were used to guide the intervention development process. We used a combination of evidence synthesis and qualitative research with the target population, health professionals, and community health personnel to develop the intervention over three main stages: (1) we identified the evidence base and selected dietary behaviours that needed to change, (2) we developed a theoretical basis for how the intervention might encourage behaviour change towards a MD and selected intervention functions that could drive the desired MD behaviour change, and (3) we defined the intervention content and modelled outcomes. RESULTS: A theory-based, culturally tailored, peer support intervention was developed to specifically target behaviour change towards a MD in the target population. The intervention was a group-based program delivered by trained peer volunteers over 12-months, and incorporated strategies to enhance social support, self-efficacy, problem-solving, knowledge, and attitudes to address identified barriers to adopting a MD from the COM-B analysis. CONCLUSIONS: The MRC and BCW frameworks provided a systematic and complementary process for development of a theory-based peer support intervention to encourage dietary behaviour change towards a MD in non-Mediterranean adults at high CVD risk. The next step is to evaluate feasibility, acceptability, and diet behaviour change outcomes in response to the peer support intervention (change towards a MD and nutrient biomarkers) using a randomized controlled trial design.

Ionic Liquid Forms of Weakly Acidic Drugs in Oral Lipid Formulations: Preparation, Characterization, in Vitro Digestion, and in Vivo Absorption Studies.

This study aimed to transform weakly acidic poorly water-soluble drugs (PWSD) into ionic liquids (ILs) to promote solubility in, and the utility of, lipid-based formulations. Ionic liquids (ILs) were formed directly from tolfenamic acid (Tolf), meclofenamic acid, diclofenac, and ibuprofen by pairing with lipophilic counterions. The drug-ILs were obtained as liquids or low melting solids and were significantly more soluble (either completely miscible or highly soluble) in lipid based, self-emulsifying drug delivery systems (SEDDS) when compared to the equivalent free acid. In vivo assessment of a SEDDS lipid solution formulation of Tolf didecyldimethylammonium salt and the same formulation of Tolf free acid at low dose (18 mg/kg, where the free acid was soluble in the SEDDS), resulted in similar absorption profiles and overall exposure. At high dose (100 mg/kg), solution SEDDS formulations of the Tolf ILs (didecyldimethylammonium, butyldodecyldimethylammonium or didecylmethylammonium salts) were possible, but the lower lipid solubility of Tolf free acid dictated that administration of the free acid was only possible as a suspension in the SEDDS formulation or as an aqueous suspension. Under these conditions, total drug plasma exposure was similar for the IL formulations and the free acid, but the plasma profiles were markedly different, resulting in flatter, more prolonged exposure profiles and reduced Cmax for the IL formulations. Isolation of a weakly acidic drug as an IL may therefore provide advantage as it allows formulation as a solution SEDDS rather than a lipid suspension, and in some cases may provide a means of slowing or sustaining absorption. The current studies compliment previous studies with weakly basic PWSD and demonstrate that transformation into highly lipophilic ILs is also possible for weakly acidic compounds.

Correlating in Vitro Solubilization and Supersaturation Profiles with in Vivo Exposure for Lipid Based Formulations of the CETP Inhibitor CP-532,623.

Lipid based formulations (LBFs) are a promising formulation strategy for many poorly water-soluble drugs and have been shown previously to enhance the oral exposure of CP-532,623, an oral cholesteryl ester transfer protein inhibitor. In the current study, an in vitro lipid digestion model was used to probe the relationship between drug solubilization and supersaturation on in vitro dispersion and digestion of LBF containing long chain (LC) lipids and drug absorption in vivo. After in vitro digestion of LBF based on LC lipids, the proportion of CP-532,623 maintained in the solubilized state in the aqueous phase of the digest was highest in formulations containing Kolliphor RH 40, and in most cases outperformed equivalent formulations based on MC lipids. Subsequent administration of the LC-LBFs to beagle dogs resulted in reasonable correlation between concentrations of CP-532,623 measured in the aqueous phase of the in vitro digest after 30 min digestion and in vivo exposure (AUC); however, the LC-LBFs required greater in vitro drug solubilization to elicit similar in vivo exposure when compared to previous studies with MC-LBF. Although post digestion solubilization was enhanced in LC-LBF compared to MC-LBF, equilibrium solubility studies of CP-532,623 in the aqueous phase isolated from blank lipid digestion experiments revealed that equilibrium solubility was also higher, and therefore supersaturation lower. A revised correlation based on supersaturation in the digest aqueous phase and drug absorption was therefore generated. A single, linear correlation was evident for both LC- and MC-LBF containing Kolliphor RH 40, but this did not extend to formulations based on other surfactants. The data suggest that solubilization and supersaturation are significant drivers of drug absorption in vivo, and that across formulations with similar formulation composition good correlation is evident between in vitro and in vivo measures. However, across dissimilar formulations, solubilization and supersaturation alone are not sufficient to explain drug exposure and other factors also likely play a role.

Increasing Fruit and Vegetable Intake Has No Dose-Response Effect on Conventional Cardiovascular Risk Factors in Overweight Adults at High Risk of Developing Cardiovascular Disease.

BACKGROUND: Improving diet and lifestyle is important for prevention of cardiovascular disease (CVD). Observational evidence suggests that increasing fruit and vegetable (FV) consumption may lower CVD risk, largely through modulation of established risk factors, but intervention data are required to fully elucidate the mechanisms by which FVs exert benefits on vascular health. OBJECTIVE: The aim of this study was to examine the dose-response effect of FV intake on cardiovascular risk factors in adults at high CVD risk. METHODS: This was a randomized controlled parallel group study involving overweight adults (BMI: >27 and ≤35 kg/m(2)) with a habitually low FV intake (≤160 g/d) and a high total risk of developing CVD (estimated ≥20% over 10 y). After a 4-wk run-in period where FV intake was limited to <2 portions/d (<160 g/d), 92 eligible participants were randomly assigned to 1 of 3 groups: to consume either 2, 4, or 7 portions (equivalent to 160 g, 320 g, or 560 g, respectively) of FVs daily for 12 consecutive weeks. Fasting venous blood samples were collected at baseline (week 4) and post-intervention (week 16) for analysis of lipid fractions and high-sensitivity C-reactive protein (hsCRP) concentrations. Compliance with the FV intervention was determined with use of self-reported FV intake and biomarkers of micronutrient status. Ambulatory blood pressure and body composition were also measured pre- and post-intervention. RESULTS: A total of 89 participants completed the study and body composition remained stable throughout the intervention period. Despite good compliance with the intervention, no significant difference was found between the FV groups for change in measures of ambulatory blood pressure, plasma lipids, or hsCRP concentrations. CONCLUSIONS: There was no evidence of a dose-response effect of FV intake on conventional CVD risk factors measured in overweight adults at high CVD risk. This trial was registered at clinicaltrials.gov as NCT00874341.

Diet patterns and cognitive performance in a UK Female Twin Registry (TwinsUK).

BACKGROUND: Plant-based diets may provide protection against cognitive decline and Alzheimer's disease, but observational data have not been consistent. Previous studies include early life confounding from socioeconomic conditions and genetics that are known to influence both cognitive performance and diet behaviour. This study investigated associations between Mediterranean (MED) diet and MIND diets and cognitive performance accounting for shared genotype and early-life environmental exposures in female twins. METHODS: Diet scores were examined in 509 female twins enrolled in TwinsUK study. The Cambridge Neuropsychological Test Automated Battery was used to assess cognition at baseline and 10 years later (in n = 275). A co-twin case-control study for discordant monozygotic (MZ) twins examined effects of diet on cognitive performance independent of genetic factors. Differences in relative abundance of taxa at 10-year follow-up were explored in subsamples. RESULTS: Each 1-point increase in MIND or MED diet score was associated with 1.75 (95% CI: - 2.96, - 0.54, p = 0.005 and q = 0.11) and 1.67 (95% CI: - 2.71, - 0.65, p = 0.002 and q = 0.02) fewer respective errors in paired-associates learning. Within each MZ pair, the twin with the high diet score had better preservation in spatial span especially for MED diet (p = 0.02). There were no differences between diet scores and 10-year change in the other cognitive tests. MIND diet adherence was associated with higher relative abundance of Ruminococcaceae UCG-010 (0.30% (95% CI 0.17, 0.62), q = 0.05) which was also associated with less decline in global cognition over 10 years (0.22 (95% CI 0.06, 0.39), p = 0.01). CONCLUSIONS: MIND or MED diets could help to preserve some cognitive abilities in midlife, particularly episodic and visuospatial working memory. Effects may be mediated by high dietary fibre content and increased abundance of short-chain fatty acid producing gut bacteria. Longer follow-up with repeated measures of cognition will determine whether diet can influence changes in cognition occurring in older age.

Undernutrition, cognitive decline and dementia: The collaborative PROMED-COG pooled cohorts study.

BACKGROUND & AIMS: Undernutrition may negatively impact cognitive function, but evidence of this relationship is not yet consolidated. Under the "PROtein enriched MEDiterranean diet to combat undernutrition and promote healthy neuroCOGnitive ageing" (PROMED-COG) project, we evaluated the association between undernutrition, and cognitive decline and incident dementia in older adults. METHODS: Retrospective data harmonization was performed on three Italian population-based studies: the Italian Longitudinal Study of Ageing (ILSA), the Progetto Veneto Anziani (Pro.V.A.), and the Bollate Eye Study-Follow-Up (BEST-FU). The associations between undernutrition, operationalized using the Global Leadership Initiative on Malnutrition (GLIM) criteria, and decline on the Mini-Mental State Examination (MMSE) or dementia incidence follow-up were evaluated with Cox proportional hazard regression models. RESULTS: The pooled cohort comprised 9071 individuals (52% females) aged between 42 and 101 years. The prevalence of undernutrition at the baseline was 14.3%, significantly higher among females (15.4% vs 13%) and in older age, ranging from 3.5% in those aged <60 years to 28.8% in those 85+ years. Undernutrition was associated with both cognitive decline over a median 8.3-year follow-up (Hazard Ratio (HR) 1.20, 95% Confidence Interval (CI) 1.02-1.41, p = 0.028) and incidence of dementia over a median 8.6-year follow-up (HR = 1.57, 95%CI 1.01-2.43, p = 0.046). For cognitive decline, the association with undernutrition was more marked in males than females (HR = 1.36, 95%CI 1.05-1.77, p = 0.019 vs HR = 1.10, 95% CI 0.89-1.36, p = 0.375). CONCLUSION: Undernutrition is prevalent among older people and is associated with an increased risk of experiencing cognitive decline and dementia. The prevention and early identification of undernutrition could be an important nonpharmacologic strategy to counteract neurodegeneration.