Clinical Research Directory

Online Dietary Weight Loss Program for Arab Adults: A Randomized Controlled Trial

This study is testing whether a culturally adapted online dietary and lifestyle program can help Arab adults in Saudi Arabia lose weight and improve their overall health. Participants will be randomly assigned to one of two groups: an online lifestyle and dietary intervention group or a usual care group receiving standard hospital-based dietary care. The online program lasts 6 months and includes 12 Arabic-language educational sessions, practical guidance on healthy eating and lifestyle habits, and support from dietitians when needed. The usual care group will receive personalized dietary advice as normally provided in the hospital setting. Researchers will compare the two groups to see how the program affects body weight, dietary habits, and quality of life over time. The goal of this study is to identify an effective and accessible weight management approach for Arab adults in Saudi Arabia.

Human Models of Selective Insulin Resistance: Alpelisib, Part I

The goal of this clinical trial is to understand how the blood sugar-lowering hormone insulin works in healthy adults versus those who are at risk for type 2 diabetes. The study will use a drug called alpelisib, which interferes with insulin's actions in the body, to answer the study's main question: does the liver continue to respond to insulin's stimulation of fat production even when it loses the ability to stop making glucose (sugar) in response to insulin. Researchers will compare the impact of single doses of both alpelisib and placebo (inert non-drug) in random order (like flipping a coin) in study participants. Participants will be asked to stay twice overnight in the hospital, take single doses of alpelisib and placebo (one or the other on each of the two hospital stays), and receive intravenous (into the vein) infusions of non-radioactive "tracer" molecules that allow researchers to measure the production of glucose (sugar) and fats by the liver. Measurements will be done both overnight, while participants are asleep and fasting (not eating or drinking other than water) and while consuming a standardized diet of nutritional beverages during the following day. The objective is to evaluate the effect of lowering insulin levels, while maintaining constant mild hyperglycemia, on plasma glucose and lipid levels.

Testing the Adipose Expandability Hypothesis In Vivo During Overfeeding

Adipose, or fat, tissue is a plastic organ that retains the ability to expand and store excess calories during positive energy balance in humans. The capacity of subcutaneous (subQ) adipose tissue to expand and remodel is an important determinant of obesity-related health complications, and impaired expansion of subQ fat tissue is thought to contribute to the risk of diseases such as the Metabolic Syndrome (MetS) and type 2 diabetes mellitus (T2D). The objectives of the study are to evaluate the changes and mechanisms of (subQ) adipose tissue expandability that occur as a result of short-term weight gain and to investigate the effects on cardio-metabolic health outcomes. Findings from this study will provide new insight into the dynamics of adipose expansion and remodeling during changes in energy balance and how this may impact future fat tissue function and metabolic health.

JiGenerations Health Cohort Study：Parental Exposure and Intergenerational Health in China

The growing recognition of maternal health's impact on offspring necessitates large-scale prospective cohort studies spanning the maternal-child life cycle. This study establishes a family-centered birth cohort of 100,000 Chinese participants, tracking from preconception through offspring adolescence to investigate early-life health trajectories and intergenerational transmission of diseases, health status, and psychological-behavioral patterns. Data collection includes biospecimens (placenta, cord blood, breast milk, blood, urine, feces) and multi-omics analysis (genomic, proteomic, metabolomic, microbiomic), alongside clinical information from preconception, pregnancy, birth through childhood (0-14 years). The cohort covers 24 stratified sites across China, incorporating real-time environmental monitoring (air pollution, meteorological data) and sociogeographic factors. Targeting reproductive-age couples (18-45 years) and their offspring, the study addresses multigenerational health linkages, urban-rural disparities, and regional diversity from 2025 to 2039. By integrating genetic, environmental and lifestyle data, this research will identify critical intervention windows and mechanisms for chronic disease transmission across generations, supporting China's "Healthy China" initiative and developing targeted strategies for population health and aging.

Health Outcomes in C-Section Infants With Fecal Microbiota Transplantation

The goal of this clinical trial is to investigate the differences in microbiota, height and weight between infants born by cesarean section and randomized to receive fecal microbiota transplant after birth. The main questions it aims to answer are: * Could micobiota transplant be used improve gut microbiota and prevent overweight or obesity. * Is the source of colonization a modifiable factor and can it be changed by using an early fecal microbiota transplant.

Lille Study for Childhood Health Promotion

Obesity could be avoided but once declared it become a chronic disease with numerous health complications, including cardiovascular and metabolic diseases, cancers, and finally a loss of life expectancy. Considering that after the age of 6 years old, half of the obese children will become obese adults, the WHO has been declared childhood obesity prevention as a health priority area. Large-scale prevention of obesity is challenging and it would be more efficient to proceed to early identification of high risks children to implement personalized prevention. The ELIPSE study main objective is to evaluate the efficacy of personalized multidisciplinary care to reduce the BMI of overweight or obese children. A 2 years educational program will be evaluated at short and longer terms (after a 12 months follow-up), and its benefits will also be assessed based on comparison with a historical control group. Along with efficacy evaluation, scientific objectives were designed to investigate clinical, genetic, social, and behavioural risk factors and to analyse potential correlations between these factors and a predisposition to overweight or obesity. Moreover, advanced analyses will be performed to decipher the impact of diverse risk profiles on the efficacy of the educational program. The motive of the ELIPSE study is to promote the health and well-being of children and their families to tackle the health burden represented by childhood overweight and obesity. Combined with innovative scientific objectives, this study ambitions to develop more efficient and more personalized preventive care methods.

Healthy Living After Knee Replacement

The purpose of this study is to examine if a weight loss program designed for adults after knee replacement improves weight loss, physical activity, pain, and function, as well as if the program is cost effective, as compared to a chronic disease self-management program.

OAT-GUT-BRAIN: Effects of Oats and Rice on Comprehensive Health of Metabolically Challenged Individuals

The overall objective of this research entity is to reveal the comprehensive health impact of oats in metabolically challenged individuals in a 6-week intervention, compared to that of rice. This is achieved by investigation of the lipids, short-chain fatty acids, inflammation markers and antioxidant status from plasma, fecal microbiome, and plasma metabolome. Additionally the effect of the 6-week diet on postprandial glycemia and postprandial satiety and vitality are investigated.

Maternal Betaine Supplementation During Breastfeeding

Developing more efficient and cost-effective prevention strategies to slow down the worldwide epidemic of obesity and chronic metabolic disease has become a public health imperative. Our previous results in humans demonstrate that lower breast milk betaine levels were associated with faster infant postnatal growth, a strong and potentially modifiable risk factor of future obesity. Betaine is a trimethylated derivative of glycine, which is present in multiple foods and occurs naturally in breast milk. In this study, we will perform a double-blind randomized placebo-controlled pilot clinical study, in which maternal diet will be supplemented with betaine for 3 months during breastfeeding; infant's growth and adiposity will be monitored until 12 months of age, and breast milk composition and gut microbiota analyzed. An additional follow-up visit will be conducted at 48 months of age to repeat microbiome analysis, determine adiposity, and perform cognitive development assessment.

Early vs. Late Time Restricted Eating vs. Daily Caloric Restriction

The goal of this clinical trial is to learn about time restricted eating as a weight loss intervention in adults with obesity. The main questions it aims to answer are: 1. How does the timing of the eating window (early vs late time restricted eating) affect weight loss and changes in metabolic risk factors? 2. How does time restricted eating compare to standard of care (daily caloric restriction) for weight loss and changes in metabolic risk factors? Participants will be randomly assigned to either early time restricted eating, late time restricted eating, or daily caloric restriction. 1. They will be asked to follow the assigned dietary strategy for 1 year and will receive a group-based program for instruction and support. 2. They will be asked at several times during the year to have their weight and body composition measured, provide blood samples, track their food, and wear monitors for physical activity and sleep.

Role of Microvascular Insulin Resistance and Cardiorespiratory Fitness Diabetes

The goal of this two-site grant proposal is to determine the role of the decreased insulin-mediated muscle perfusion found in type 2 diabetes in contributing to the development of cardiac and skeletal muscle dysfunction and subsequent functional exercise impairment. In addition, it is also our goal to determine whether exercise training attenuates insulin resistance and restores insulin-mediated perfusion to the heart and to skeletal muscle, leading to improved cardiac function and exercise performance.

A Trial to Compare the Extent to Which Maridebart Cafraglutide (AMG 133) is Made Available in the Body When Administered Using Two Subcutaneous Presentations

The main objective of this trial is to evaluate the pharmacokinetics (PK) of maridebart cafraglutide administered as a single dose using two different SC presentations in participants living with overweight or obesity.

Evaluating the Influence of Diet-induced Weight Loss on Fat (Adipose) Tissue's Insulin Sensitivity and Testosterone Synthesis in Women With Overweight or Obesity, Insulin Resistance, and Hyperandrogenemia

The investigators will measure plasma concentrations of the hormones insulin and testosterone as well as measures of insulin sensitivity in women with overweight or obesity who have insulin resistance (IR). Women who meet these criteria that also have elevated total or free testosterone will be eligible to participate in the diet intervention. The dietary intervention is designed to produce a 5% reduction in starting body weight to test whether weight loss will acutely lower fasting insulin and testosterone concentrations.

Understanding the Health Effect of a Bioactive Peptide From Egg: A Pilot Study

Bioactive peptides derived from food proteins show potential for improving human health. One of such promising peptides is namely IRW made from egg white hydrolysate and composed of three peptides. This is a feasibility study to assess the acute effect of IRW in egg white hydrolysate for the management of high sugar and blood pressure. Participants at high risk of type 2 diabetes (T2D) or having T2D will undergo 4 consecutive treatments of 1 day each (randomly), during which they will consume a standardized breakfast with a smoothie containing different protein powders. Each treatment will be separated by a minimum of 1-week. Participants in the healthy control group will undergo 1 treatment only (one day).

Pregnancy Exercise Mode Effect on Childhood Obesity

The overall objective of this proposal is to conduct a longitudinal prospective study of overweight/obese (OW/OB) pregnant women and their offspring to determine which prenatal exercise mode will have the greatest impact on maternal and infant cardiometabolic health. This information may lead to clinical practice recommendations that improve childhood health. This randomized controlled trial will recruit 284 OW/OB pregnant women randomized to an exercise intervention (aerobic (AE), resistance (RE), or aerobic+resistance exercise (AERE)) or to no exercise; their infants will be measured at 1, 6, and 12 months of age. This design will test our central hypothesis that AERE and RE training during pregnancy will improve maternal and offspring cardiometabolic outcomes to a greater extent than AE alone. This hypothesis will be tested with two specific aims: Aim 1. Determine the influence of different exercise modes during OW/OB pregnancy on infant cardiometabolic health and growth trajectories. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve offspring neuromotor and cardiometabolic measures at 1, 6, and 12 months postpartum (e.g. decreased %body fat, BMI z-score, heart rate \[HR\], non-HDL, and C-Reactive Protein (CRP); increased insulin sensitivity) compared to infants of OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving infant measures. Aim 2. Determine the most effective exercise mode in OW/OB pregnancy on improving maternal cardiometabolic health outcomes. Hypothesis: AE, RE, and AERE by OW/OB pregnant women will improve both maternal cardiometabolic health measures (e.g. decreased BMI z-score, non-HDL, % body fat, HR, weight gain) across pregnancy (16-36 weeks' gestation) and overall pregnancy outcomes (e.g. lower incidence of gestational diabetes, pre-eclampsia, hypertension during gestation) compared to OW/OB pregnant women that do not exercise; AERE and RE will have the greatest impact on improving maternal health measures, with the AERE group having the highest compliance. The proposed study will be the first to provide an understanding of the influence of maternal exercise modes on the cardiometabolic health and growth trajectories of offspring who are at increased risk due to maternal OW/OB. This work will have a significant impact on reducing the cycle of OB, potentially providing the earliest and most efficacious intervention to decrease or prevent OB in the next generation.

PILI 'Āina Household

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

'Ai Pono Cooking Demonstrations

Native Hawaiians' traditional lifestyles and diets ensured the mutual health and well-being of the land and its inhabitants, which stand in stark contrast to the disproportionately high prevalence of diet-related, cardiometabolic diseases they experience today. In this project, the investigators will adapt and test an evidence-based multilevel intervention entitled PILI 'Āina to improve the self-management of prevalent cardiometabolic diseases and reduce risk factors for developing new diet-related illnesses and implement and evaluate the impact and sustainability of community-wide cooking demonstrations. The objectives of this project are to optimize the effectiveness and sustainability of PILI 'Āina, improve diet quality, cardiometabolic markers, promote traditional Native Hawaiian diets, and improve social cohesion.

Prognostic Value of SII and SIRI in Obesity-Related Metabolic Complications

This observational study aims to evaluate the diagnostic and prognostic value of the systemic immune-inflammatory index (SII) and the systemic inflammation response index (SIRI) in individuals with overweight or obesity. The study will assess their association with obesity status, metabolic complications, lifestyle patterns, dietary indices, and established inflammatory biomarkers. Participants will undergo anthropometric assessment, laboratory testing, dietary evaluation, and follow-up for response to different obesity treatment modalities over 3 years. The study intends to determine whether SII and SIRI can serve as clinically useful predictors of metabolic risk and treatment outcomes of obesity.

Biased GRK Signaling Via β2-Adrenergic Receptors in Human Skeletal Muscle

This longitudinal mechanistic physiological study examines biased β2-adrenergic receptor (β2-AR) signaling in human skeletal muscle, with emphasis on G protein-coupled receptor kinase (GRK)-mediated pathways. Participants will receive daily oral dosing of the GRK-selective long-acting β2-agonist ATR-258 for 8 weeks. Muscle biopsies and physiological measurements will quantify GRK-, cAMP/PKA-, and β-arrestin-related signaling, fiber-type specificity, and potential receptor desensitization with repeated stimulation.

Effect of a Postbiotic Supplementation in Overweight and Obese Subjects: A Randomized Controlled Trial (PARABIOTICS-2).

The principal objective of this project is to evaluate the effect of a postbiotic supplement (inactivated microorganism) on body composition and other physiological and metabolic parameters related to excess body weight in overweight or obese adult men and women, as well as to determine changes in the gut microbiota associated with these outcomes. Specific objectives are focus on evaluate the effect of the intervention on the following parameters: * Changes in body weight and composition. * Changes in glucose tolerance. * Changes in gut microbiota (metagenomics). * Changes in urinary and serum metabolites. * Changes in routine biochemical variables related to carbohydrate and lipid metabolism, as well as liver parameters. * Changes in specific markers involved in obesity pathology, such as insulin, leptin, adiponectin, and cytokines MCP-1, TNF, CRP, and others. * Adherence to the nutritional recommendations and the gummy containing postbiotic formula. * Changes in the level of physical activity. Target sample size is 114 subjects, including a 10% of drop out. Participants will be allocated in two groups for 12 weeks: * Experimental group (n=57): nutritional recommendations + postbiotic supplement/gummy. * Placebo group (n=57): nutritional recommendations + placebo supplement/gummy. Participants will visit the nutritional intervention unit at weeks 1 and 12. A follow-up phone call will be conducted at week 6.

Cut Down on Carbohydrate in the Dietary Therapy of Type 2 Diabetes - The Meal Box Study

The cornerstone in the initial treatment of type 2 diabetes (T2D) is lifestyle modification, involving-among other things-a healthy diet. However, scientific evidence regarding optimal nutrition therapy for patients with T2D is insufficient. This clinical study will examine the effect of a carbohydrate-reduced high-protein (CRHP) diet compared to a conventional diabetes (CD) diet for 12 months on metabolic function and body weight in patients with T2D. The hypothesis of the study is that the CRHP diet will improve metabolic control and the cardiovascular risk profile of patients with T2D to a greater extent than the CD diet. In particular, the expectation is that, compared with the CD diet, the CRHP diet will: * Reduce diurnal and postprandial glycemia measured by continuous glucose monitoring (CGM) and thereby facilitate a significant reduction of glycated hemoglobin (HbA1c) * Reduce body weight * Reduce ectopic fat deposition in the liver and the pancreas * Improve the blood lipid profile * Reduce or not affect blood pressure with no adverse effect on heart rate variability * Increase insulin sensitivity and secretion * Decrease inflammatory markers in the blood * Improve satiety * Reduce or not affect the need for antidiabetic, antihypertensive and/or lipid-lowering medications To reinforce the results and knowledge generated from the primary study, participants will be invited to partake in a 12-month follow-up period after the initial 12 months of intervention.

Nutrition Care in Patients Living With Chronic Pain

The investigators' purpose is to develop and test the feasibility, usability, and satisfaction of the Diet4painrelief app as a platform for implementing nutrition care in a specialist pain rehabilitation clinic. The Diet4painrelief will consist of two components: a) a screening tool for nutrition status b) an individually tailored behavior change program aiming to improve the dietary habits and behaviors of patients living with chronic pain. Part I: Included 20 patients with complex chronic pain to examine the feasibility and outcomes of evidence-based Interdisciplinary Pain Rehabilitation Program (IPRP) integrated with nutrition care. The Diet4painrelief includes a screening tool to assess basic nutritional status as well as their intake of key unhealthy and healthy foods and drinks (through three 24hour-dietary recordings or food diary). Thereafter, the patients receive a personalized behavior change program for dietary optimization. The investigators will design and adapt 6 modules in the digital platform (Diet4painrelief app) based on the International Association for the Study of Pain (IASP) recommendations (6 aspects about 'nutrition and pain') and Sweden's food culture. Clinical outcomes using patient-reported data on socio-demographics, pain aspects, psychometric data, physical disability, and quality of life will be measured at three occasions: first appointment (Pre-IPRP), immediately after completing the rehabilitation program (Post-IPRP), and at a 12-month follow-up (FU-IPRP). Blood samples will be taken to identify biomarkers at the same occasions that provide objective information on metabolic and nutritional abnormalities and further to evaluate the effect of the dietary intervention on changing of pain rehabilitation outcomes. Part II: Included 192 patients with complex chronic pain. Half of the participants receive IPRP and nutrition care (described above) and the other half receive standard IPRP.

CHOICE to AVOID or RESIST

This trials will formally test whether participants' active choice of self-regulatory strategies (AVOID or RESIST) leads to greater adherence to weight management strategies by comparing the CHOICE arms to the randomized arms of the parent intervention, AVOID/RESIST (IRB STUDY00001652: AVOID-RESIST).

WB-EMS Effects on Cardiometabolic Risk Factors

From the age of 50 onwards, there is a disproportionate decline in muscle strength, mass and function, which can be prevented or at least delayed by physical training. Unfortunately, many training programmes are very time-consuming and strenuous and are therefore not carried out consistently. Whole-body electromyostimulation (WB-EMS), a technology in which all major muscle groups are stimulated with an adjusted stimulation level, could be a time-effective and joint-friendly alternative. However, there are some contraindications to the widespread use of this technology, which are particularly common in middle-aged and elderly people. For example, high blood pressure, which affects more than half of men over the age of 50 in Germany, is considered a contraindication for WB-EMS training. However, this assessment is not very reliable; at least, acute WB-EMS application does not lead to an increase in blood pressure. In addition, there are no study results available for long-term WB-EMS application in people with high blood pressure. The present study particularly investigate whether and to what extent several weeks of WB-EMS training has an effect on resting blood pressure in people with mild blood pressure. Additionally, the effect of WB-EMS on other cardiometabolic risk factors and physical function will be addressed.