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Diets low in diverse fibre-rich plant foods contribute to the rise of chronic disease. The BIOME study (NCT06231706; 6-week parallel randomised controlled trial) in 399 adults (35–65 years; BMI 18·5–40 kg/m2; fibre intake < 20 g/d) investigated a whole-food plant blend containing > 30 ingredients, rich in (poly)phenols, fibre and micronutrients. Participants were randomised (1:1:1) to the blend (30 g/d), an isoenergetic control (bread croutons, 28 g/d) or probiotic (Lactobacillus rhamnosus, 15bn CFU/d). Analysts were blinded to allocation. The primary outcome was change in ‘favourable’ and ‘unfavourable’ gut microbiome species (ZOE Microbiome Health Ranking 2025); secondary outcomes included blood metabolites, symptoms, stool output, anthropometry, hunger, sleep, energy and mood. A crossover sub-study explored postprandial glucose, hunger and mood. Of 349 participants analysed (fifty excluded), self-reported adherence was > 98 %. The 30+ plant blend resulted in more species changing relative abundance at 6 weeks v. control (57 v. 14 species-level genome bins (SGB), P < 0·001) and probiotic (57 v. 4 SGB, P < 0·001). There were no significant between-group differences in microbiome health ranks of significantly changing species (increasing or decreasing). Blend participants self-reported reduced indigestion, constipation, heartburn and flatulence and increased energy v. control (all P < 0·05). Six related but no serious adverse events occurred. In the sub-study, adding the blend to a high-carbohydrate meal (v. meal alone) reduced hunger, increased fullness and energy (3-h incremental AUC, all P < 0·05), with no effect on postprandial glucose. This 30+ plant blend represents a simple strategy to modify gut microbiome composition and benefit gastrointestinal symptoms in healthy adults.
Asparagus (Asparagus officinalis) contains bioactive compounds such as polyphenols and saponins, which have been shown to influence cognition, mood, sleep, stress and related biomarkers. However, the evidence from human studies has not been systematically synthesised. To address this, we conducted a systematic review evaluating the effects of asparagus-based products on cognitive, affective, sleep outcomes and related biomarkers in adults. A systematic search of PubMed, Scopus, Web of Science, PsycINFO, Google Scholar and Amino Up Ltd’s website (up to April 2025) identified studies assessing asparagus supplementation in adults, following PRISMA guidelines (PROSPERO registration number: CRD42025636834). Human studies that employed randomised controlled trials or quasi-experimental designs and assessed the effects of orally administered asparagus-based products on cognition, mood, sleep or relevant biomarkers were included. Eighteen studies (thirteen randomised controlled trials and three pre-post-studies; 503 participants) were included. Cognitive improvements were observed in reaction time, accuracy and mental fatigue, while mood and stress-related outcomes showed reductions in anxiety and depressive symptoms. Sleep outcomes consistently demonstrated improvements in sleep quality and duration, while biomarker data showed effects on cortisol levels. Asparagus supplementation may offer modest benefits for cognition, mood and stress-related physiology, with particularly consistent effects on sleep quality. However, the magnitude of benefits varies by population, dose and duration, and the heterogeneity of interventions, small sample sizes and limited studies may constrain the generalisability of findings. Well-powered, long-term clinical trials are needed to determine optimal dosage, clarify mechanisms and assess efficacy across diverse populations.
Functional neurological disorder (FND) is characterised by disabling motor, sensory and/or seizure symptoms. Contemporary models highlight the possible involvement of altered affective and autonomic regulation and interoceptive processing in FND. However, accessible, mechanism-informed interventions remain limited.
Aims
This study sought to examine the feasibility, acceptability and possible benefits of tailored somatic yoga for people with FND, aiming to directly target altered emotional and bodily regulation in this group.
Method
This single-site, two-arm randomised feasibility trial allocated adults with FND to 6 weeks of either somatic yoga (weekly remote sessions plus home practice manual) or a music-based relaxation control. Feasibility outcomes included recruitment, retention, adherence and acceptability. Secondary outcomes, assessed at baseline, week 3, week 6 and 3-month follow-up, included FND symptom burden, psychological symptoms (anxiety, depression, dissociation), general functioning, health-related quality-of-life, interoceptive awareness and autonomic symptoms.
Results
Seventy-six enquiries were received. Thirty participants consented (100%), 27 were randomised (90%), 23 commenced the trial (77%) and 21 completed it (70%). Recruitment and retention targets were met, with 100% retention in the yoga arm. Adherence was high across both groups, although digital logging of home practice posed usability challenges. Exploratory analyses indicated large effect sizes for self-reported FND symptom improvement and interoceptive awareness in the yoga group, with effects sustained at follow-up.
Conclusions
Individually delivered somatic yoga was found to be feasible, acceptable and safe for people with FND. Our results also suggest potential benefits of somatic yoga for FND symptom improvement and interoceptive awareness, supporting progression to a fully powered trial.
People with schizophrenia spectrum disorders (SSDs) experience high rates of obesity and metabolic dysfunction, contributing substantially to excess morbidity and mortality. Glucagon-like peptide-1 receptor agonists (GLP-1 RAs) such as semaglutide and tirzepatide have demonstrated substantial efficacy for weight and glycaemic outcomes in the general population, but evidence in people with SSDs remains limited.
Aims
To synthesise all placebo-controlled, randomised controlled trials (RCTs) examining semaglutide and/or tirzepatide in people with SSDs.
Method
A preregistered systematic review and meta-analysis of RCTs examining the efficacy and safety of semaglutide and/or tirzepatide in adults with SSDs was conducted. Outcomes and adverse events were pooled using random-effects meta-analysis. Certainty of evidence was assessed using the GRADE criteria.
Results
Three trials (n = 258) met inclusion criteria, examining semaglutide dosages of 1.0–2.0 mg over 26–36 weeks. No trials examining tirzepatide were found. Semaglutide significantly reduced body weight (−11.32 kg; 95% CI −15.35 to −7.29), body mass index (−3.58 kg/m2; 95% CI −4.86 to −2.30), haemoglobin A1c (−0.37%; 95% CI −0.51 to −0.22) and fasting glucose (−0.54 mmol/L; 95% CI −0.94 to −0.13). In adverse event analyses, semaglutide was associated with increased risks of abdominal pain (risk ratio 2.93; 95% CI 1.13–7.60), vomiting (risk ratio 2.57; 95% CI 1.39–4.77) and constipation (risk ratio 3.23; 95% CI 1.14–9.18). There was no evidence of increased risk of serious adverse events.
Conclusions
Semaglutide produces clinically meaningful improvements in weight and glycaemic outcomes in people with SSDs, with an adverse event profile consistent with known gastrointestinal effects of GLP-1 RAs in the general population. These findings support semaglutide as a promising adjunctive metabolic intervention in this population, although larger and longer trials, specifically those testing tirzepatide, are needed to better characterise heterogeneity of effects and long-term safety of these promising pharmacological treatments.
Consuming fruit juice/smoothies could help overcome barriers to fruit and vegetable (F&V) intake. However, their contribution towards F&V intake within a healthy diet is contentious. We investigated how F&V intake is affected by UK 5-a-day advice, with and without one portion/d of fruit juice/smoothies and explored how these interventions impacted markers of health. Healthy individuals (n 42) with low F&V intake (≤ 2 servings/d) completed a 4-week, parallel-group randomised controlled trial (ClinicalTrials.gov ID: NCT06628401). Participants were randomised to (1) control, (2) whole F&V (FV) or (3) whole F&V plus fruit juice/smoothies (FV + FJ). All groups received weekly financial support (to remove financial barriers to F&V purchase in the intervention groups). FV and FV + FJ also received a co-designed educational booklet. We investigated the intervention effects on self-reported F&V intake (primary outcome), biomarkers of intake and metabolism, mood, gut symptoms and acceptability. Post-intervention F&V intake differed between groups (P < 0·001; ηp2 = 0·62). It was significantly higher in FV ((estimated marginal means (se)); 8·9 (0·64) portions/d, P < 0·001) and FV + FJ (6·6 (0·64), P < 0·001) v. control (2·45 (0·64)), but there was no difference between FV and FV + FJ (P = 0·051). Both interventions showed good acceptability. Depression symptoms differed between groups (P = 0·01; ηp2 = 0·21); they were significantly lower in FV + FJ than control. There were no differences in anxiety or gut symptoms, nor in intake or metabolic biomarkers. A financial and educational intervention based on UK 5-a-day recommendations, with or without fruit juice/smoothies, significantly increased short-term F&V intake and benefited mood without adversely impacting health markers in the short-term. Funder: Fruit Juice Science Centre.
This study evaluated the effectiveness of a one-year smoking cessation intervention for people with severe mental illness compared with treatment as usual (TAU) in outpatient mental healthcare.
Methods
The KISMET study is a pragmatic cluster-randomized controlled trial conducted in 21 outpatient mental healthcare teams in the Netherlands. Eleven teams delivered the KISMET intervention comprising cognitive-behavioral and peer support, combined with optional pharmacological reatment. Ten teams participated in the TAU condition. We collected data between October 2022 and July 2024. The primary outcome was self-reported smoking cessation at 12 months, verified through exhaled carbon monoxide levels below 10 parts per million. Secondary outcomes included depression and anxiety (HADS), severity of psychotic symptoms (PANSS-6), quality of life (SF-12), disease self-management (PAM-13), lipid profile, blood pressure, body mass index, glucose level, and physical fitness. Crude and adjusted linear and multivariable logistic regression and mixed model analyses were performed.
Results
Eighty-nine participants were included in the KISMET intervention and 44 in TAU. Smoking cessation rates were significantly higher in the KISMET group at 3 months (OR 12.1, 95% CI 1.4 to 103.7) and at 12 months (OR 4.2, 95% CI 1.0 to 17.2) but not at 6 months (OR 1.9, 95% CI 0.5 to 6.9). No significant differences between groups were found for secondary outcomes. Dropout rates were 58% in the intervention and 32% in the TAU group.
Conclusions
The KISMET intervention shows potential without signs of physical or psychopathological complications. However, results must be interpreted with the high dropout rates in mind.
Malnutrition remains a major public health challenge in low- and middle-income countries and disproportionately affecting children under five. Eggs, given their high nutrient density and relative physical or economic accessibility, have been tested for their effect on improving nutritional outcomes in children under five. However, findings from scientific exercises to test the impact of egg-based trials on child growth have not been systhematically pooled and synthesised. Therefore, this meta-analysis aimed to synthesise evidence on the impact of egg-based interventions on the nutritional status of children underfive as determined by weight-for-height Z-score (WHZ), weight-for-age z-score (WAZ), and height-for-age z-score (HAZ). Research articles of randomised controlled trials published between 2013 and 2023 were identified through a comprehensive search of PubMed/MEDLINE, Web of Science, CINAHL, Embase, Science Direct, Google Scholar, and African Index Medicus data bases. Articles evaluated the effect of egg-based interventions against alternative diets, behaviour-change education, or no alternative intervention were included. Primary outcomes are WHZ, WAZ, and HAZ. Random-effects models were used to pool effect sizes (mean difference), and subgroup analyses and meta-regression explored sources of heterogeneity. Publication bias was assessed using funnel plots and Egger’s test. Seven studies involving 3673 children met the inclusion criteria. Egg-based intervention significantly improved WAZ (MD: 0.33; 95% CI: 0.11–0.55) and WHZ (MD: 0.30; 95% CI: 0.12–0.48). However, no significant effect was observed on HAZ (MD: 0.05; 95% CI: –0.05–0.14). It is figuredout that egg-based interventions can improve weight-related nutritional outcomes (WHZ and HAZ) among children underfive in sub-Saharan Africa, but not linear growth (HAZ).
People with intellectual disability experience substantial health inequities, including higher multimorbidity, increased healthcare utilisation and markedly reduced life expectancy. High-quality research is essential to address these disparities. The National Institute for Health and Care Research (NIHR) funded Research Delivery Network provides the infrastructure/expertise/support needed to deliver NIHR-funded studies, and supports studies funded by a non-commercial/industry partner. However, the effectiveness of NIHR-funded studies versus those supported in driving impactful intellectual disability research remains unclear.
Aims
To evaluate and compare the outcomes of NIHR-funded and supported intellectual disability research.
Method
All NIHR studies (funded/supported) relating to intellectual disability (2010–2020) were identified through systematic register searches. Primary outcomes included publication rates and impact on local, national and international clinical guidelines. Data collection was supplemented with a questionnaire to chief investigators and literature searches. Quantitative analyses examined associations between funding status, study design, publication and guideline impact, whereas qualitative responses explored implementation challenges.
Results
In total, 88 projects were identified, and 42% (37/88) were NIHR-funded. Overall, 81% of studies generated at least one publication and 28% informed clinical guidelines. NIHR funding was not significantly associated with publication or guideline impact. Randomised controlled trials (RCTs) were significantly more likely to be published and more likely to influence non-UK national and international guidelines than non-RCTs. The amount of funding showed no association with impact. Qualitative findings highlighted funding constraints, staff capacity and stakeholder engagement as key determinants of implementation.
Conclusions
NIHR-funded intellectual disability research was no more likely than NIHR-supported studies to result in publications or guideline impact.
Individuals with type 2 diabetes are at increased risk for developing CVD. We assessed how dietary counselling on a high-quality, fibre-rich diet influenced cardiometabolic health of patients with type 2 diabetes. In this 6-month trial, 121 patients with type 2 diabetes (67 (sd 8·7) years, 68 % men, BMI 27·8 kg/m2) were assigned to dietary counselling (n 61) or standard care (n 60). Counselling included 4–7 individual sessions with a dietitian, aimed at increasing fibre intake to improve diet quality. The primary outcome was a composite risk score estimating 10-year CVD risk. Secondary outcomes included diet quality, assessed by the Dutch Healthy Eating Index-2015 (DHD15-index), HbA1c, LDL-cholesterol, blood pressure, body weight and medication use. Diet quality score at baseline was 115 (sd 26) and similar across groups. Over 6 months, DHD15-index scores improved by 4·5 points (95 % CI: −0·2, 9·1) in the intervention group v. control, but not significant. The change in 10-year CVD risk across the 6 months of the trial (primary outcome) did not differ between groups −0·1 %, 95 % CI: −0·2, 0·1. Changes over time in HbA1c (–1·1 mmol/mol, 95 % CI: −4·4, 2·3), LDL-cholesterol (0·0 mmol/l, 95 % CI: −0·2, 0·3), blood pressure (–1 mmHg, 95 % CI: −6, 4), body weight (–0·1 kg, 95 % CI: −1·2, 1·1) or medication use did not differ between groups. Dietary counselling for 6 months slightly improved adherence to a high-quality, fibre-rich diet in patients with type 2 diabetes but did not significantly impact cardiometabolic health or medication use.
There is a need for deeper understanding of neurological and psychological aspects of paedophilic disorder (PeD) to improve management of the disorder and thereby prevent child sexual abuse (CSA). Functional magnetic resonance imaging (fMRI) measures have been suggested as imaging biomarkers that may contribute towards this goal. A previous study using degarelix, a testosterone suppressing drug, showed promising results in decreasing the risk of committing CSA among individuals with PeD. In this study, we evaluate functional connectivity (FC) related to PeD and degarelix treatment.
Methods:
We used independent component analysis on resting state (rs)fMRI data acquired at baseline as well as two and ten weeks after injection of degarelix (or placebo) to evaluate FC alterations related to PeD and the degarelix treatment effect.
Results:
FC was altered in relation to several resting state networks in individuals with PeD compared to healthy controls at baseline. At follow-up time points, however, group comparisons were inconclusive and did after FDR correction not render statistically significant FC alterations when comparing patients to controls or related to degarelix treatment, CSA dynamic risk scores or comorbidities.
Conclusion:
We found FC alterations in PeD compared to healthy controls at baseline, however, no consistent, treatment specific FC signature of degarelix was demonstrated.
The planetary health diet (PHD) is a mostly plant-based diet that aims to optimise human health while minimising the environmental impact of food production. Limited data exist on whether the PHD fulfils key nutritional requirements during pregnancy. This research aimed to examine the PHD in early pregnancy and how it aligns with daily nutrient intake and European Food Safety Authority (EFSA) dietary guidelines. Pregnant women (n 678) from two Irish cohorts (ROLO and MicrobeMom) were analysed, and PHD index (PHDI) scores were assigned based on data from 3-d food diaries. Women were dichotomised by the median score to create a ‘High PHDI’ (> 88·99) and a ‘Low PHDI’ group (≤ 88·99). Differences in nutrient intakes and adherence to dietary guidelines between ‘High’ and ‘Low’ PHDI groups were explored. Compared with those with a ‘Low’ score, those with a ‘High’ PHDI score reported higher intakes of dietary fibre (g/d) (17·32 (13·39, 21·08) v. 21·74 (18·28, 25·88), P < 0·001), Fe (mg/d) (10·48 (8·48, 12·82) v. 12·06 (9·48, 14·60), P < 0·001), folate (µg dietary folate equivalent per d) (250·73 (193·88, 312·45) v. 279·57 (219·43, 356·81), P < 0·001) and Ca (mg/d) (837·75 (695·36, 1056·72) v. 956·57 (751·84, 1155·03), P < 0·001). A greater proportion of women in the ‘High PHDI’ group met EFSA recommendations for dietary fibre intake (10·3 % v. 28·9 %, P < 0·001). The PHD may support maternal nutritional adequacy in pregnancy while promoting environmental sustainability. Our findings provide valuable insights that can inform future dietary recommendations for pregnancy, contributing to both maternal health and planetary well-being.
This paper summarises the UK Scientific Advisory Committee on Nutrition’s (SACN) 2023 and 2025 assessments of processed foods and health and its 2025 review of the WHO guideline on non-sugar sweeteners (NSS). On processed foods, SACN sought to identify available evidence on existing processed food classification systems, applying NOVA to UK National Diet and Nutrition Survey data and associations between food processing and health outcomes. For NSS, health outcomes of greatest policy relevance to the UK were considered. The assessments were undertaken in line with SACN’s Framework for the evaluation of evidence. SACN found that NOVA dominated the research literature and ultra-processed food (UPF) constitutes a significant proportion of UK dietary energy intake, especially among children. Higher UPF consumption was consistently associated with increased risks of adverse health outcomes, although not for all subgroups. Important limitations included most evidence being observational and inconsistent adjustment for covariables. For NSS, randomised controlled trials indicate a small reduction in body weight when NSS replace sugars, whereas prospective cohort studies indicate higher NSS intake is associated with higher measures of body fatness and may be associated with a range of adverse health outcomes. The findings were based on low- and/or very low-certainty evidence. SACN concluded that, on balance, most people are likely to benefit from reducing consumption of processed foods high in energy, saturated fat, salt and free sugars and low in fibre. SACN made a precautionary recommendation that intake of NSS be minimised. SACN made a range of recommendations to the government on processed foods and sweeteners.
Parenteral nutrition (PN) is used when sufficient oral or enteral nutrition is not possible or feasible. Current guidelines provide limited practical guidance in emergency surgical patients, and the evidence is sparse. The EATERS trial aims to investigate the effect of early supplemental PN on postoperative infections in major emergency abdominal surgery patients. The EATERS trial is an investigator-initiated, multicentre, randomised controlled trial. The trial will include 342 adults with reduced oral intake after emergency abdominal surgery, randomising them in a 1:1 ratio to early or postponed supplemental PN. The intervention group (early) will receive supplemental PN starting on postoperative day (POD) 2 for up to five days. The control group (postponed) will receive standard care and, if oral intake remains insufficient, will begin supplemental PN on POD5 for up to five days. The primary outcome is the incidence of postoperative nosocomial infections during admission. Outcome assessors and the statistician will be blinded to the treatment allocation. The secondary outcomes include non-infectious complications during admission, length of stay, mortality risk at 30 and 90 d, energy and protein intake, serious adverse events and readmission risk within 30 and 90 d of surgery. Analyses will follow the intention-to-treat principle and logistic regression used for primary outcome analysis. The EATERS trial will provide novel insights into the timing of PN in a high-risk patient population. This protocol and statistical analysis plan will reduce bias and increase transparency in the conduct and analysis of the trial.
Anorexia nervosa (AN) is an eating disorder that is mediated by psychological and metabolic factors, yet it is unclear how these factors interact. The NAMA trial objective is to clarify the metabo–psychiatric interaction and identify how it affects AN patients’ behaviour. This randomised trial will recruit thirty-six treatment-naïve female AN patients, 13–18 years of age, and thirty-six matched healthy controls. Participants will undergo psychiatric assessments followed by 12-h overnight fasting. The next morning, baseline assessments of outcomes will be performed. Patients will be randomly allocated 1:1 to receive a mixture with calories or receive a mixture without calories. Healthy controls will also be allocated to receive mixtures with/without calories. Mixtures will be standardised for taste and appearance, and allocation will be masked. The primary outcome measure is resting-state functional MRI 60 min post-consumption of the mixture. Secondary outcomes include (1) blood samples to study markers reflecting metabolic states, hunger/satiety and stress responses, (2) psychometric evaluations of subjective experiences and (3) assessment, in a second meal 3 h later, of the effects of previous calorie intake on subsequent food consumption. This article describes the study protocol, including the analysis plan, for a randomised controlled trial to comprehensively evaluate the effects of calorie intake in AN. The trial will distinguish psychological and metabolic neuronal networks associated with food intake and uncover how their integration affects food intake and other hallmark symptoms in AN. The aim is to accelerate treatment development by identifying brain mechanisms that drive AN.
Assessing depression symptoms in people with a chronic illness is challenging due to possible bias from overlapping somatic symptoms associated with both depression and chronic illnesses. Previous studies, however, have found that people with a chronic illness do not report more somatic symptoms on depression measures than people without a chronic illness with similar levels of mood and cognitive symptoms. The reason for this surprising finding is unknown. Our primary objective was to evaluate differences in mean sum scores of Patient Health Questionnaire-8 (PHQ-8) somatic symptom items (sleep disturbances, fatigue, appetite changes) in people with a chronic illness when the items were administered outside the context of a depression questionnaire versus as part of the PHQ-8. Secondary objectives were to evaluate individual somatic item scores. We hypothesised that people who completed somatic items outside of a depression assessment would have significantly higher scores than those who completed items as part of a depression assessment.
Methods
We conducted a randomised controlled experiment within the Scleroderma Patient-centred Intervention Network (SPIN) Cohort, a multinational cohort of people with systemic sclerosis. SPIN Cohort participants were randomly allocated to complete the PHQ-8 with somatic items (sleep disturbances, fatigue, appetite changes) presented separately from psychological items and without any indication that they were part of a depression questionnaire (Reordered Items arm) or in standard format (Standard PHQ-8 arm). Participants were automatically randomised when they logged into the SPIN Cohort platform to complete routine research assessments. The primary outcome was the mean sum score of PHQ-8 somatic items. Secondary outcomes were the mean scores of individual somatic items. Differences were assessed using between-groups t-tests.
Results
In total, 851 participants were included (N = 428 in Reordered Items arm, N = 423 in Standard PHQ-8 arm). Mean (SD) PHQ-8 score was 6.0 (5.3) for all participants. We found no statistically significant differences in PHQ-8 somatic item sum scores (0.05 points; 95% confidence interval [CI]: −0.29 to 0.38) or in mean scores for item 3 (sleep disturbances; 0.04 points; 95% CI: −0.09 to 0.19), item 4 (fatigue; 0.03 points; 95% CI: −0.11 to 0.16) and item 5 (appetite changes; −0.03 points; 95% CI: −0.15 to 0.10).
Conclusions
We did not find evidence that responses to PHQ-8 somatic items were influenced by whether participants were aware they were responding to items about depression. This finding supports the validity of self-reported questionnaires for depression symptom assessment in people with chronic medical conditions.
Major depressive disorder (MDD) is the leading cause of disability worldwide, affecting roughly 322 million people. Recently, doses of psilocybin have shown promise in treating mood disorders, sparking interest in other dosing practices. According to anecdotal reports and observational studies, microdosing psilocybin yields benefits to mental health; however, rigorously controlled trials have failed to produce compelling evidence for this.
Aims
To conduct a phase II, double-blind, placebo-controlled, randomised partial crossover trial to compare microdosing psilocybin to placebo for MDD, evaluating its safety, tolerability and preliminary antidepressant effects.
Method
Forty adults with MDD will be randomised to four doses of psilocybin (2 mg) or placebo (maltodextrin) once weekly over 4 weeks, then four doses of psilocybin (2 mg) once weekly for an additional 4 weeks. The primary efficacy end-point will be change in depression symptoms, as measured at baseline (0 weeks), after the experimental phase (4 weeks), and after the open-label phase (8 weeks). A battery of mood, well-being, attention, creativity, mindfulness and pro-sociality measures will be administered at each time point. Follow-ups will occur every 6 months for up to 2 years after the trial start date, as part of a long-term extension study.
Results
The results of the primary outcome of this trial will be published as a manuscript in a peer-reviewed science or medical journal regardless of the magnitude or direction of effect.
Conclusions
Findings will inform future research on microdosing psilocybin for MDD, regarding dose regimens, effect sizes and expectancy bias. Findings will also facilitate discussions on the comparable benefits of sub- versus threshold doses of psilocybin and the therapeutic value of radically altered perception.
This randomised controlled trial examined the effect of a 4-week, high-dose (Lf-High, 600 mg/d) or low-dose (Lf-Low, 200 mg/d) oral lactoferrin (Lf) intervention v. placebo on immune cell responses to respiratory virus, immune cell subsets and systemic inflammation. In healthy older adults (n 103, ≥50 years old), ex vivo cytokine release of interferon (IFN)-α2, IFN-γ, IL-6 and TNF-α from rhinovirus A-16 (RV-16) or influenza A virus (H1N1) stimulated peripheral blood mononuclear cells, circulating immune cell subsets, and plasma IL-6, C-reactive protein (CRP) and TNF-α were assessed. Ninety-seven participants completed the 4-week intervention (Lf-High n 32, Lf-Low n 31, placebo n 34, withdrawals n 6). There was no difference in RV-16 or H1N1-induced IFN-γ release between groups. RV-16-induced IL-6 was lower in Lf-High v. placebo (P = 0·001), and RV-16-induced IFN-α2 was higher in Lf-High v. Lf-Low (P = 0·04). Lf-High increased total T cells (P = 0·03) and CD4+ T cells (P = 0·03) v. placebo. Lf-Low reduced neutrophil (P = 0·04), natural killer cell (P = 0·045), activated CD8+ T cell (P = 0·03) and γδ T cell (P = 0·03) frequency v. placebo. Plasma IL-6 (P = 0·004) and CRP (P = 0·03) were lower following Lf-High v. Lf-Low, but not placebo. Both high- and low-dose Lf altered ex vivo immune cell responses after 4 weeks. High-dose increased T-cell subsets, promoting adaptive immunity, and reduced systemic inflammation, while low-dose reduced proinflammatory and cytotoxic immune cells. High- and low-dose Lf supplements may have immunoceutical benefits in older adults.
Forced displacement heightens mental health risks for children, including psychological, environmental and economic stressors, yet few interventions address whole-family needs within humanitarian contexts. Family-systemic approaches show promise, but evidence on interventions addressing social determinants of mental health remains limited. We will conduct a single-masked, two-arm randomised controlled trial with 550 families in East Amman, Jordan, to evaluate StrongerTogether, a modular whole-family intervention with a financial literacy component. Families experiencing multiple psychosocial challenges will be randomised 1:1 to receive the intervention or enhanced treatment as usual. The trial employs sequential dual outcomes testing, evaluating effectiveness through: (1) upstream improvements in at least one of three primary outcomes (family functioning, parenting practices and caregiver mental health) and (2) direct improvements in adolescent mental health among those with elevated baseline distress. We will also evaluate two implementation tools: ReachNow for family case detection and FamilyACT for facilitator competency assessment. A mixed-methods process evaluation will examine implementation, effectiveness and potential sustainability of core and optional modules. This will be the first rigorous evaluation of an integrated whole-family intervention addressing social and environmental determinants of mental health in humanitarian settings. Findings will inform evidence-based approaches to family mental health support and contribute validated tools for implementation at scale.
The new psychosocial goal-setting and manualised support intervention for independence in dementia (NIDUS-Family) is a manualised dementia care intervention.
Aims
To evaluate whether goal-setting plus NIDUS-Family is more effective than the control condition (goal-setting and routine care) in supporting dyads’ (family carers and care recipients with dementia) attainment of personalised goals; and to determine participant-perceived goal relevance over 24 months.
Method
We randomised dyads from community settings (2:1): to NIDUS-Family, a manualised psychological intervention tailored to goals that dyads set by selecting modules, delivered in 6–8 video call/telephone sessions over 6 months then 2–3 follow-ups monthly for 6 months; or to control. Outcomes were goal attainment scaling (GAS) (primary) at 18 and 24 months, functioning, quality of life, time until care home admission or death, carer anxiety and depression. Primary analysis, a mixed-effects model, accounted for randomisation group, study site, time, intervention arm facilitator and repeated measurements.
Results
In the period 2020–2021, 204 participants were randomised to intervention and 98 to control; 164 (54.3%) and 141 (46.7%) dyads completed 18- and 24-month outcomes, respectively.
In the primary analysis, including 277 participants contributing 6-, 12-, 18- or 24-month outcomes, adjusted GAS mean differences (intervention–control) at 18 and 24 months were 11.78 (95% CI 6.64, 16.93) and 8.67 (95% CI 3.31, 14.02), respectively. Secondary outcome comparisons were not significant. The hazard ratio for dying or care home admission was 0.80 (95% CI 0.45, 1.42; intervention versus control), and 0.87 (95% CI 0.41, 1.82) and 0.59 (95% CI 0.26, 1.33) for death and care home admission, respectively. Among baseline GAS goals, carers considered 436 (78.0%) relevant at 18 months and 383 (78.5%) at 24 months.
Conclusions
NIDUS-Family improved attainment of GAS goals over 2 years.