Clinical trials

This randomized single-blind clinical trial aims to compare the effects of different dry needling and electrical dry needling techniques applied to latent myofascial trigger points in the extensor digitorum muscle of the dominant forearm in healthy adults. Participants will be randomly allocated to one of five groups: a control group, a Hong fast-in and fast-out dry needling group, a rotational dry needling group, a bipolar electrical dry needling group, or a monopolar electrical dry needling group. The main outcomes will be post-needling soreness intensity and duration. Secondary outcomes will include pain during the needling procedure, pressure pain threshold assessed by algometry, handgrip strength, range of motion of finger flexion and wrist palmar flexion, perceived comfort during the intervention, and perceived interference of post-needling soreness with daily activities. Assessments will be performed at baseline, 5 minutes after the intervention, and at 24, 48, and 72 hours after the intervention.

The primary objective of this study is to evaluate the effectiveness of the Mentis Plus+ Positive Mental Health Promotion Programme for caregivers (Mentis Plus+ Caregivers), compared with usual primary health care, in improving positive mental health among adult informal caregivers of people with dementia. The secondary objectives are to assess the programme's effectiveness in reducing symptoms of depression, anxiety and stress, as well as caregiver burden, compared with usual care.

Polyphenols, precisely resveratrol, with red wine as the most substantial source, was associated with improvements in cognitive function. Also, the loss of muscle mass and strength in elderly, that significantly increases dependency of these people, it could be attributed to alterations in gut microbiota through the "gut-muscle axis" and this underline the urgent need to efficiently find out any intervention or preventive approach via modulation of gut microbiota to improve muscle function in elderly. In this context, red wine polyphenols exert their effects through interaction with gut microbiota following the well-known two-way interaction between polyphenols and gut microbiota by promoting the proliferation of beneficial bacteria and increasing their abundance. Similarly, aging cognitive decline can be modulate by microbiota, notably through "gut-brain axis". Additionally, dietary polyphenols can delay inflammation or/and oxidation on the onset of age-related cognitive decline or muscular oxidation or cardiovascular factors risk factors, all of them relevant factors for the onset of physical frailty and dependence in elderly. Moreover, wine is a singular alcoholic beverage with a high content of phenolic compounds of a very diverse nature on which numerous protective effects on health have been described. In fact, wine, in addition to alcohol, contains a complex mixture of polyphenols, including anthocyanins and non-coloured phenols as proanthocyanidins, flavonols, hydroxycinnamic and hydroxybenzoic acids, stilbenes and lignans. Thus, the bioprotective effects of wine polyphenols could be the consequence of the synergistic effect of this complex mixture of polyphenols from the grape and the winemaking process. That is why it is essential to clarify whether consumption of polyphenols from red wine provided by a nonalcohol red wine within a healthy diet can produce beneficial effects on health, differentiating this pattern from a general consumption of alcohol generally associated with negative effects. Based on the ethical limitations to carry out diet intervention studies with wine in humans, this project proposes the use of a nonalcoholic wine as vehicle of the complex mixture of red wine polyphenols. The hypothesis of our research is that regular consumption of red wine polyphenols, 150 mg/day, delivered through a nonalcoholic red wine, in the context of a Mediterranean diet (MD pattern), could promote protective mechanisms for a healthy aging, especially through its beneficial effects on cognitive and locomotor abilities and mediated by the modulation of the intestinal microbiota (composition, function and associated metabolome). The main objective of the WinAging project is to add knowledge concerning the diet modulation of molecular mechanisms of the aging process through multi-omic approaches based on the potential health effects of a dietary strategy by a sustained MD supplementation with nonalcoholic red wine rich in polyphenols to tackle cognitive and locomotor abilities in early elderly home-dwelling subjects. The specific objectives: * Objective 1. To develop a nonalcoholic red wine with high phenolic content and sensorial acceptability. * Objective 2. To evaluate the chronic effects of the intake of wine polyphenols (average dose 150 mg/day) delivered through a nonalcoholic red wine in the context of a MD in early elderly home-dwelling subjects, and applying participatory research to increase adherence of subjects in the clinical intervention study. * Objective 2.1. To identify selective biological phenolic metabolites in human urine samples to be used as biomarkers of nonalcoholic red wine intake. * Objective 2.2. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of cognitive ability. * Objective 2.3. To assess the effects of the diet supplementation with red wine polyphenols on the improvement of locomotor ability * Objective 2.4. To evaluate the effect of the diet supplementation with red wine polyphenols on the improvement of cardiovascular disease (CVD) risk factors. * Objective 3. To unravel the underlying mechanisms involved in the potential beneficial effects of red wine polyphenols on aging. * Objective 3.1. To evaluate the influence on microbiota composition, function and microbial catabolites. * Objective 3.2. To evaluate the impact on inflammation and gut health. * Objective 3.3. To evaluate the impact on metabolic pathways related with aging * Objective 3.4. To analyze the impact on age-related epigenetic modifications * Objective 3.5. To deeply characterize the underlying muscle signalling pathways affected using an animal model of aging. * Objective 4. To apply integrative computational analyses for the identification of variables (clinical or gut-related) more determinant for a successful prevention of locomotor and cognitive abilities associated with wine polyphenols.

In 2018, for the first time, the number of people aged 65 and over exceeded the number of children under the age of 5. A rise in ageing societies is coming, and new efforts are needed to ensure that this increase in life expectancy is accompanied by years of health and a good quality of life. The new focus for our ageing society will be an extended healthspan, the period of life spent in good health. This is an important shift, as population ageing is a defining global trend of our time. By 2030, 1 in 6 people in the world will be 60 years and older, according to the World Health Organization. In this sense, the imperative to maintain the health and activity levels of the senior demographic has never been more critical. Advances in healthcare, science, and technology have contributed to increased longevity, yet this does not always equate to improved health. The prevalence of malnutrition or the risk thereof among the elderly living independently in Europe ranges from 13.5% to 29.7%, highlighting a pressing need for nutritional intervention. Addressing this, the pursuit of innovative nutritional sources and the creation of new food products enriched with these sources are essential to bridging the nutritional gap, ensuring healthier aging prospects for this population. The formulation of food products tailored to the elderly must consider their unique nutritional requirements, particularly concerning protein and micronutrient intake. Recent advances in food technology facilitate the development of plant-based beverages that are palatable, nutritionally adequate, and accessible. Moreover, the growing market share of plant-based non-dairy beverages provides a promising alternative, offering opportunities to deliver bioactive compounds with health-promoting properties, appealing to health-conscious and lactose-intolerant consumers. Given the nutritional challenges and health risks faced by the aging population, particularly in relation to protein intake and malnutrition, another critical aspect that warrants attention is the immune system's health through diet. The immune system, which naturally weakens with age, plays a crucial role in the elderly's ability to resist infections and recover from illnesses. Research highlights the impact of not only macronutrients but micronutrients such as vitamins D, C, E, and zinc on enhancing immune responses, suggesting that diets rich in these nutrients can significantly benefit immune health in older adults. Strengthening the immune system through diet becomes even more pertinent considering the increased vulnerability of the elderly to infectious diseases, including respiratory infections like influenza and pneumonia, which are leading causes of morbidity and mortality in this population. Developing food products that are not only nutritionally adequate but also tailored to support immune function could provide a dual benefit: improving general health and enhancing the body's defence mechanisms. The present research project is structured into three coordinated phases and is enabled by the multidisciplinary nature of the IMMUGOLD consortium. In the first phase, AZTI conducted an extensive literature and technical review to identify functional ingredients capable of supporting immune function while remaining compatible with the technological, sensory, and stability requirements of a plant-based beverage. This process identified vitamin D, zinc, FOS, and L-leucine as the most suitable bioactive components, considering bioavailability, processing stability, and expected physiological effects. In the second phase, COSTA carried out the development and reformulation of the oat-based beverage to ensure nutritional adequacy, ingredient stability under thermal treatment, and organoleptic acceptability for older consumers. Finally, the third phase involves a clinical study, to be executed by Universitat Rovira i Virgili (URV), which aims to evaluate the effects of the newly developed fortified beverage on markers of immune function and systemic inflammation in community-dwelling older adults, with secondary outcomes including nutritional status and other health-related parameters relevant to ageing. The multidisciplinary expertise of the consortium, including computational modelling, ingredient research, nutrition, food product development, and clinical epidemiology, ensures the feasibility of the project and the successful achievement of its objectives: AZTI provides evidence-based solutions for functional ingredients; COSTA develops innovative plant-based beverages; and URV contributes extensive experience in designing and implementing nutritional programs and clinical studies.

Spain is experiencing a demographic shift towards an ageing population. In 2022, 20.1% of Spaniards were 65 or older, a figure projected to reach 30.4% by 2050. The trend is especially marked in rural areas, where outmigration of younger generations has left a high concentration of older residents. In Catalonia's Priorat county, the share of people aged 65+ already exceeds 20%, reaching 30%, and even 40% in some villages. The ageing process brings biological changes that reduce locomotor and cognitive abilities, limiting autonomy and quality of life. In rural areas, these challenges are compounded by social isolation and the lack of support networks, making older adults more vulnerable. Healthy lifestyle habits-such as balanced nutrition, regular exercise, avoiding tobacco and alcohol, and good sleep-can help delay dependence, lower the risk of chronic disease, and improve well-being. To promote these habits, social innovation must generate new services and approaches that address real needs, barriers, and motivations in adopting healthier lifestyles. Our group's research shows that participatory science is an effective tool to promote healthy ageing in rural settings. A three-month intervention co-designed with older adults in villages of ≤2,000 inhabitants led to improvements in locomotor function, measured through sarcopenia parameters, and enhanced quality of life in areas such as vitality, mental health, and social functioning. A distinctive feature of this approach is shared decision-making between residents and policymakers, ensuring that solutions are adapted to local realities. This fosters greater adherence, empowerment, and long-term sustainability of co-created strategies. This project is directly relevant to public policy through collaboration with the Consell Comarcal del Priorat, which represents 23 municipalities. Their recent report identified ageing as a major concern for both institutions and residents. The project's results can therefore guide health policies-decisions, plans, and actions-that address local needs while considering available resources and ensuring long-term sustainability. By focusing on health promotion and disease prevention, the project ensures that policies are evidence-based and subject to evaluation. The partnership with the Consell Comarcal also aligns with Sustainable Development Goal 3 (Health and Well-being) of the 2030 WHO Agenda and supports the "Health in All Policies" approach, fostering integrated strategies across sectors. The principal aim of the study is to evaluate the effectiveness of a participatory science intervention study in improving lifestyle habits (dietary habits, physical activity, substance use, and sleep quality), quality of life, emotional well-being, and locomotor capacities through the assessment of sarcopenia parameters (muscle strength, muscle mass, and physical function) in young-old adults (≥60 years) living in rural areas of the Priorat region (Catalonia, Spain). Specific Objectives: 1. To describe the health status of older people residing in the Priorat region by evaluating: lifestyle habits (diet, substance use, physical activity, and sleep), risk of malnutrition, functional capacity based on sarcopenia parameters, mental capacity (mental health and emotional well-being), and quality of life. 2. To improve lifestyle habits (diet, physical activity, sedentary behaviour, sleep habits, and substance use-alcohol and smoking), emotional well-being and personal relationships to avoid unwanted loneliness, quality of life, and locomotor abilities based on sarcopenia parameters (muscle strength, muscle mass, and physical function). 3. To reduce the risk of malnutrition. 4. To compare the health status of two groups: those aged 60-74 (young-old adults) and those aged 75 and over (older people). 5. To identify the needs, barriers, and motivations of older people through focus groups, including participants aged 60-74, those over 75, and stakeholders such as members of the public administration supporting the project. 6. To compare the differences in needs, barriers, and motivations identified by the young-old adults (60-74 years) and the older people (≥75 years). 7. To actively involve older participants in the co-creation of health promotion activities and an intervention designed for them and their peers. 8. To implement an intervention based on proposals generated during the co-creation process to improve their lifestyle (dietary habits, physical activity, substance use, well-being, and sleep behaviours), quality of life, and locomotor abilities. 9. To analyse environmental barriers, using the "Age-Friendly Cities and Communities Questionnaire (AFCCQ)", in the villages of the Priorat region that may influence the ability to maintain a healthy lifestyle and quality of life for people aged 60-74 and those aged 75 and over.

This study aims to develop and implement a preventive intervention through a mobile application to help pregnant women feel better emotionally and cope with the changes of pregnancy in a more positive way. The idea is to offer practical and accessible tools that allow them to better manage stress, emotions and preparation for motherhood. The intervention proposed in this study is based on psychological strategies that have proven to be effective, such as relaxation exercises, techniques to manage stress and strategies to improve mood, strengthen the relationship with the partner and foster the bond with the baby before its birth. The application is designed to accompany pregnant women from the beginning of pregnancy to the postpartum period. It has different programs that include weekly activities on various important topics, such as physical health care, emotional management, connection with the baby during pregnancy, preparation for childbirth and the first months of the newborn's life. To evaluate the effectiveness of this tool, a study will be carried out with pregnant women treated by the Catalan Health Service. Participants will be randomly assigned to one of two study groups: the experimental group (in which participants, in addition to the usual medical care offered during pregnancy, will have access to the programs and activities of the app organized in a weekly plan of 5 activities and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum) or the control group (in which participants will receive the usual medical care offered during pregnancy, but will not have access to the programs and activities of the app and will have to answer the study questionnaires at weeks 16 and 36 of pregnancy and postpartum). Women who use the app are expected to experience greater emotional well-being and a lower risk of developing mental health problems during pregnancy. In addition, they may feel more prepared for motherhood, take better care of their health, have a more positive birth experience and a lower risk of postpartum depression. These women are also expected to develop a stronger bond with their baby and adapt better to the new stage of motherhood.

Research has shown that the prevalence of chronic pain in adolescents is high and increasing. These young people report significant changes in both their physical and psychological functioning. Currently, psychosocial treatments enjoy strong empirical support and are crucial to maintaining and improving the quality of life of adolescents suffering from chronic pain. However, the availability of these evidence-based interventions is insufficient to meet the high demand, especially outside of large cities. The aim of this project is to develop a digital treatment that helps improve the quality of life of adolescents with chronic pain and complementary websites for their parents and teachers.

Chronic postsurgical pain is a health problem with a great societal impact: approximately 20% of all children and adolescents undergoing surgery will develop chronic pain. Importantly, the risk and protective factors that are known (e.g., anxiety, catastrophizing, pain beliefs and pain coping) are modifiable, thus there is a huge potential for the development of both preventive and protective programs to avoid the transition from acute to chronic pain or reduce the impact in the lives of patients when it has already developed.

Populations around the world are aging and this demographic transition will impact almost every aspect of society. Furthermore, the COVID-19 pandemic has highlighted the seriousness of gaps in policies, systems and services. According to the World Health Organization (WHO) plan for 2021-2030, a decade of concerted global action on healthy ageing is urgently needed to ensure that older people can realize their potential in dignity and equality in nutritional requirements. An effective way to address the inherent demographic change, which translates into the health status of older people, is through the maintenance of adequate nutritional status. Public health services require new funding to address this problem, but if we bring new strategies to health policies, by improving nutrition, we could impact the reduction of costs at the level of medical care in the ageing population. In older people, according to the latest guidelines on nutritional requirements in geriatrics from the Spanish Nutrition Foundation (FEN), the British Nutrition Foundation and The European Society for Clinical Nutrition and Metabolism (ESPEN), multinutrient strategies instead of mononutrient strategies, are gaining importance due to relevant scientific evidence based on controlled and randomized clinical trials. Therefore, following the nutritional requirements in healthy ageing, an important aspect is to strengthen immunity in this population. Consequently, the food industry is booming in the development of new functional alternatives, such as plant-based beverages, which are well positioned in the market and can offer healthy functional beverage options to people of early elderly age (60 to 75 years) as a target population due to the ease with which they are ingested. Therefore, investments in small and medium-sized companies to encourage the incorporation of trained doctoral personnel and add innovation value to this type of product are essential for resilience. Therefore, the present proposal hypothesizes that, following the nutritional needs for healthy ageing, a multinutrient-optimized beverage as a functional food can improve immunity and reduce inflammation and oxidation in women and men in the elderly population.