Clinical Research Directory

Design and Development of a Functional Plant-based Beverage to Improve Nutritional Status and Immunity for the Early Elderly People to Get Well-healthy Ageing

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.

Dynamic Effects of Different Anesthetic Agents on the Immune Function of Healthy Volunteers

This study recruits healthy volunteers and randomly assigns them in a 1:1:1:1 ratio to the following groups: Propofol group, Sevoflurane group, Ciprofol group, and Control group. Subjects in the different groups will undergo anesthesia with the corresponding general anesthetic drug, while subjects in the Control group will receive no anesthesia. Peripheral blood samples will be collected at specified time points: before anesthesia induction, upon emergence from anesthesia, 24 hours after anesthesia, and 48 hours after anesthesia. Single-cell multi-omics analysis will be performed on these samples using single-cell sequencing technology. The aim is to investigate the independent effects of different general anesthetic drugs on human immune function in the absence of surgical trauma, and to further explore the potential immunomodulatory effects of commonly used clinical anesthetics.

Impact of SCFA Supplementation on Gut Microbiome Composition of Kidney Transplant Recipients

This is a randomized, double-blind, placebo-controlled clinical trial designed to evaluate the effects of high-dose short-chain fatty acid (SCFA) supplementation on the gut microbiome and host metabolome in stable kidney transplant recipients. Participants will be randomly assigned to receive either 1000 mg of sodium butyrate per day or placebo for a duration of 12 weeks. Comprehensive profiling of the serum and urinary metabolome, along with analysis of the gut microbiome composition and diversity, will be conducted at three time points: baseline, after the intervention period (week 12). The biochemical parameters and the level of tacrolimus will be also examined.

A First-in-Human Phase I Trial of OX118 in Healthy Volunteers

This is a first-in-human, phase 1 study of OX118 in healthy volunteers, designed to investigate the safety and tolerability of OX118, as well as its pharmacokinetics (the drug's concentration in the blood and excretion from the body). The study will include a total of 32 participants: healthy men and women aged 18-60 years with a body mass index (BMI) between ≥18.5 and ≤30.0.The study is divided into five cohorts where OX118 will be given as a single dose intravenously (into the blood). The study consists of 7 clinic visits taking place over a period of approximately 77 days (including a 28-day screening period). During the study, subjects will be given the study drug (OX118) or placebo. Both the study drug and the placebo will be given as a single dose as an intravenous (directly into the blood) infusion. A pre-arranged schedule will determine whether subjects will receive the study drug or the placebo.

Immunoprofilling of Peripheral Blood Mononuclear Cells in Children With Attention Deficit/Hyperactivity Disorder

The goal of this observational study is to learn about The immune cell landscape of peripheral blood mononuclear cells in children with ADHD compared to typically developing controls. The main question it aims to answer are: 1.Testing the differences in immune cell subpopulations, protein expression and signaling pathways and cell subsets between two groups 2. Exploring the correlations between immune function in PBMC and resting-state brain functional networks in children with ADHD. Participants will be taken peripheral blood about 5 ml , cognitive assessment including Intelligence testing, Stroop color-word test and Trail making test, clinical interview and brain structural and functional MRI.

Impact of Uterine Immune Profiling and Personalized Treatments in Patients Receiving a Single Blastocyst: a Matched Controlled Study

A recent randomised controlled trial and previous large cohort studies have shown that the uterine immune environment is a crucial element in improving the performance of Assisted Reproductive therapy (ART). As previous studies mixed Day-3, Day-5, single or doble embryo transfer, the clear influence of the endometrial environment on the embryo itself and its type of transfer (fresh or freeze thawed) need further investigation. To complement previous studies, the present matched- pair study aims to select the population who exclusively received a single Day-5 embryo transfer (SET) and benefitted of a uterine immune profiling between 1 January 2020 and 30 June 2023 before the SET Day-5. This population will be matched to a population. who did not have uterine immune profiling in the nine months prior to the single Day 5 embryo transfer between 2018 and 2023. The matching criteria are the maternal age (+/-1 year), the past history of ART (same number of previous oocytes pick-up, same number of previous embryo transfer) and the same type of transfer (IVF, ICSI, frozen transfer) and the same category of expansion of the blastocoel (B1-B2/ B3-B4/ B5-B6). The primary end-point is the live birth rate (LBR) following the Day 5 SET in the population who benefited from pre-SET immune profiling versus the LBR following the Day 5 SET in the pair- matched population who did not benefit from pre-SET uterine immune profiling Secondary end point are the clinical pregnancy rate and miscarriage rate per SET in the two paired populations

The Lymphocytic Infiltrate of Lung Tumors.

The study is configured as a monocentric observational transversal biological study. The main objective of the study is the reconstruction of the molecular organization of tumors of the thoracic cavity, in particular non-small cell lung cancer (NSCLC). The study involves the collection of clinical data and biological material (blood and tumor tissue) from 70 subjects diagnosed with thoracic tumors.

The Effects of Night Shift Work on Health Across the Menstrual Cycle

The study aims to investigate the effects of sleep deprivation on women's health across different phases of the menstrual cycle.

Effects of Almond Consumption on Innate and Adaptive Immune System

Almonds are a rich matrix of different nutrients with demonstrated benefits on immune system. This proposal examines the effect of regular consumption of almonds on innate and adaptive immune system in healthy individuals with overweight regularly consuming a Western-style diet and unhealthy snacks.

Sex-differential Host-microbiome CVD Risk - A Longitudinal Cohort Approach

The XCVD study investigates the influence of sex hormones on the composition of the gut microbiome and the possible emergence of cardiovascular risk factors. It will follow 200 healthy transgender individuals for two years during their hormone replacement therapy (HRT) and analyze them for the possible emergence of cardiovascular risk factors in relation to changes in the gut microbiome, metabolome, and immunome. We would also like to phenotype cardiovascular disease.