Clinical trials

The menopausal transition is associated with a decline in oestrogen levels, contributing to adverse metabolic changes including increased central adiposity, systemic inflammation, and insulin resistance. These changes are linked to a higher risk of developing type 2 diabetes in postmenopausal women. Recent evidence suggests that the gut microbiota plays an important role in metabolic regulation and glucose homeostasis. Menopause-related hormonal changes may alter the composition and function of the gut microbiome, with downstream effects on insulin sensitivity. Additionally, certain gut bacteria (i.e., Bifidobacterium species) regulate circulating oestrogen via β-glucuronidase activity, highlighting a potential interaction between microbial composition and hormonal balance. Observational findings support associations between menopausal stage, gut microbiota alterations, and insulin homeostasis. Prebiotics are non-digestible compounds that selectively stimulate beneficial gut bacteria and may improve metabolic outcomes. Modulation of the gut microbiota through prebiotic supplementation represents a promising non-pharmacological strategy to improve glucose control. Multiple studies have demonstrated that inulin (a common prebiotic) can improve glucose regulation and aid weight loss in individuals with obesity, prediabetes, or type 2 diabetes. However, to date, no randomised controlled trials have specifically investigated prebiotic supplementation in postmenopausal women with prediabetes using dynamic measures such as the Oral Glucose Tolerance Test (OGTT). The present study aims to investigate the effect of daily consumption of an inulin-containing prebiotic gut health drink (ió everyday) on glucose control in postmenopausal women with prediabetes. The primary objective is to determine whether the intervention improves glycaemic control. Secondary objectives include exploration of changes in metabolic markers and assessment of the role of the gut microbiota in mediating these effects. It is hypothesised that consumption of ió everyday will improve glucose control in prediabetic women who have recently undergone menopause. This hypothesis is supported by evidence demonstrating that inulin and soluble corn fibre can improve glucose regulation and support weight management in individuals with obesity, prediabetes, or type 2 diabetes, as well as findings from a previous study (Ethics Ref ID: LSC 23/383), which demonstrated that one month of ió everyday consumption significantly reduced fasting glucose, with a trend towards weight reduction and no reported adverse effects.

Maternal diet influences breast milk nutritional profile; however, a national survey undertaken by the researchers revealed that non-for-profit donor milk banks in the U.K. do not provide specific dietary information to donors. Moreover, the researchers have shown that donor milk in the U.K. provides very low levels of the omega-3 and omega-6 polyunsaturated fatty acids (PUFAs), docosahexaenoic acid (DHA) and arachidonic acid, respectively. These are essential for brain development and immune system function, and preterm infants receiving donor milk do not receive sufficient levels of these nutrients. There is therefore an urgent need to develop nutritional guidelines and resources for milk donors. Following a systematic review the researchers developed evidence-based nutritional information resources for donors, which would also be applicable more generally to lactating mothers. Those resources were developed in consultation with donors, and healthcare professionals, including dietitians and lactation consultants. Researchers will evaluate the effectiveness of these resources in terms of acceptance and compliance, and also changes in milk DHA content. The researchers will also assess whether providing feedback on individual's milk DHA content increases milk DHA levels. If successful these resources will be introduced into milk banks across the U.K., and promoted to the wider breastfeeding community.

This study will examine whether an artificial intelligence (AI) avatar-led mental health programme can help employees experiencing symptoms of depression. The programme delivers structured, self-guided psychological support over several short sessions that participants complete online over a period of several weeks. Approximately 50-80 adults will take part. Participants will be randomly assigned either to start the AI programme immediately or to continue with their usual support and access the programme later. All participants will complete questionnaires before and after the study period to assess changes in mood, anxiety, and work functioning. Some participants will also be invited to take part in brief interviews to share their experiences of using the programme. The aim of the study is to evaluate whether this AI-based intervention can improve mental health and workplace functioning, and to assess how acceptable and safe it is for use in a working population.

The primary objective of this trial is to evaluate a school-based intervention designed to promote mental health among at-risk adolescents from low-income communities in Malaysia. The study will employ a two-arm, cluster randomised controlled trial design, comparing a school-based intervention to a control condition. Adolescents will be recruited from at least 20 secondary schools located in economically disadvantaged rural and urban areas of Malaysia. Assessments will take place at multiple time points: during screening, at baseline (pre-intervention), immediately after the intervention (8 weeks), and at two follow-up points-6 and 12 months post-intervention. The primary outcomes are a reduction in anxiety and depressive symptoms, along with improved mental wellbeing at the 12-month follow-up.