Clinical Research Directory

RWS of of Liraglutide Alone and in Combination With Orlistat for Weight Loss in Overweight/Obese Patients.

To evaluate the differences in weight loss between liraglutide monotherapy and combined with orlistat in overweight/obese patients.

A Study of SYNT-101 to Test Safety, Tolerability and Pharmacodynamics of SYNT-101 in Healthy and Overweight Adults

A Phase 1, single-center, randomized, double-blind, placebo-controlled study to evaluate the safety, tolerability, and pharmacodynamics of single and multiple dose regimens of SYNT-101 in healthy and overweight adults.

Behavioral Weight Loss and Sleep Health Intervention

This is a 6-month single-arm pilot and feasibility study designed to examine if a behavioral weight loss (BWL) intervention with an added sleep health program (BWL+SLEEP) can achieve clinically meaningful weight loss and improvements in a composite sleep health score. The investigators will also evaluate the feasibility of recruitment and retention of study participants and will obtain feedback from participants to improve the program's incorporation of strategies to improve sleep health.

Study of the Efficacy and Safety of Nicotinamide in Patients With Liver Fibrosis (NICOFIB)

The objective of this clinical trial, a pilot study, is to assess the impact of nicotinamide (NAM) on individuals with hepatic fibrosis. The main question it aims to answer is: \- To determine if the treatment with NAM is able to arrest, or even reduce, the hepatic fibrosis. In addition, we also want to study the effect of NAM on: * General parameters (weight, HOMA-IR, etc). * Adiposity distribution (liver and body). * Systemic inflammation. * Thermogenic capacity of adipose tissue. * Microbiota composition. Researchers will compare NAM to a placebo, to see if NAM can arrest or revert hepatic fibrosis and its associated effects. Participants will take either NAM or placebo. The dosage will be 1.2g/m2 NAM per day, for one year.

Eatit's Obesity Intervention: Effects on Weight, Eating Habits and Health

Obesity is a growing public health problem in Sweden, but access to care varies depending on geographical location. Eatit´s multimodal digitally dietitian-supported lifestyle intervention offers an accessible treatment alternative, but its clinical effects in practice need to be documented. The aim of this pilot study is to evaluate the effect of Eatit´s multimodal digitally dietitian-supported lifestyle intervention for weight loss in adults with obesity. The main question is: \- Does body weight change after six months of using the program? Secondary questions are: * Does waist size change after six months of using the program? * Do self-rated eating habits improve after six months of using the program? * Does self-rated health improve after six months of using the program? Participants will use the Eatit program for six months and answer questions about their weight, waist size, eating habits and health. The program integrates behavior change techniques with individualized nutrition counseling provided by licensed dietitians. * During the first three months, participants use Eatit's core program through the app, with weekly support by a dietitian via video calls and text messages. * The core program consists of a weekly reading section combined with a related homework assignment. * After completing the core program, participants continue with monthly video sessions with a dietitian, focusing on the skills that were most helpful during the initial phase or on areas such as receiving support to initiate physical activity. * Weight and waist size are recorded in the app every week. * Questionnaires on eating habits and health are completed at baseline, after three months, and after six months.

Plant-Based Online Weight Loss Through Education and Resources Program and Study

This is an interventional study that will evaluate the feasibility, implementation, and efficacy of an online, 12-week, plant-based, nutrition education program in a community setting. Participants will meet with a physician and a registered dietitian once a week to learn about a plant-based diet and receive support and practical help in making the dietary changes. Body composition, blood sugar control, cholesterol levels, and food costs will be measured at the start and end of the study.

Sex Hormones as Regulators of the Age- and Sex-dependent Benefits of Caloric Restriction

Obesity increases the risk of type 2 diabetes, cardiovascular disease, and certain cancers, primarily due to elevated abdominal fat storage. With nearly two-thirds of the UK population living with overweight or obesity, there is an urgent necessity for evidence-based public health guidance to promote healthy weight. Calorie deficit can facilitate weight loss and body fat reduction, leading to health benefits, such as improved blood glucose control. Current weight management advice centres on lifestyle modification, incorporating changes to diet and physical activity to support a calorie deficit. However, existing dieting recommendations fail to consider gender or age. This is a surprising oversight, as it is well established that health outcomes vary significantly between men and women across the lifespan. Further, the menopause may have an impact on fat storage linked to changes in sex hormones. Our recent research, involving both mice and humans, has indicated that females are less responsive to weight loss and fat reduction during dieting. This study aims to understand endocrine and metabolic sex-based differences in obesity and calorie restriction, with a particular focus on women's health. We plan to conduct a diet study with 75 participants, encompassing both younger and older men and women, to monitor changes in energy expenditure and body composition using gold-standard techniques, such as doubly-labelled water. Blood and abdominal fat tissue samples will be collected to investigate how sex hormones might elucidate these differences. The aim of the study is to enhance our understanding of diet and women's health to combat obesity and promote healthy ageing.

Acute Effects of Isoenergetic HIIE Vs. MICE on Key Parameters of Fat Mass Loss in Young Females with Overweight or Obesity

Overweight and obesity, particularly increased total and/or abdominal fat mass (FM), are strongly linked to the development of cardiovascular diseases. Managing obesity effectively requires lifestyle and dietary modifications, including increased physical activity. Among the various exercise strategies, Moderate-Intensity Continuous Training (MICT) and High-Intensity Interval Training (HIIT) are widely recommended for reducing FM. Compared to MICT, HIIT is a time-efficient approach, often perceived as more enjoyable, and has been shown to promote greater total and abdominal fat loss in a shorter period. However, the precise mechanisms underlying this enhanced fat loss remain unclear. This study aims to compare the acute effects of two isoenergetic exercise sessions - MICE (Moderate-Intensity Continuous Exercise) and HIIE (High-Intensity Interval Exercise) - on key physiological responses involved in fat mass loss. Specifically, we will assess plasma catecholamine levels during exercise and recovery, as well as oxygen consumption, substrate oxidation, and appetite over the 2-hour post-exercise period in young females with overweight or obesity. By elucidating the role of catecholaminergic stimulation as a potential regulator of fat mass loss, this research could provide valuable insights for optimizing exercise strategies in weight management and metabolic health.

Effects of D-Chiro-Inositol Combined with Metformin on Insulin Resistance in People with Overweight or Obesity and T2DM

This study evaluates the efficacy of D-Chiro-Inositol (DCI) as an add-on therapy to metformin in improving insulin resistance, measured by the HOMA index, in people with overweight or obesity and type 2 diabetes mellitus (T2DM). Secondary outcomes include glycemic variability, indirect calorimetry, respiratory quotient, and other metabolic parameters.

Effect of Vegetables on Weight Status of University Population

Obesity rates have more than doubled globally since 1990, with 2.5 billion overweight adults by 2022, and 890 million of them living with obesity (WHO, 2023). In Pakistan, approximately 30% of adults are overweight or obese, with 21% overweight and 9% obese. Non-communicable diseases now account for 58% of deaths in the country. WHO recommends daily consumption of non-starchy vegetables to aid weight loss and reduce BMI and fat mass, especially for overweight and obese individuals. This randomized controlled trial (RCT) will be conducted at the University of Veterinary and Animal Sciences (UVAS) in Lahore, Pakistan, targeting the university population, including students, teaching, and non-teaching staff with BMI ≥23 kg/m². A total of 40 participants will be recruited, with 20 assigned to the intervention group (receiving 2-3 cups of non-starchy vegetables daily) and 20 to the control group (receiving only dietary guidelines). Weight, BMI, and fat mass will be measured before and after the trial using an InBody 270. The data will be analyzed using SPSS version 25, with paired and independent t-tests to compare changes within and between groups. Multiple logistic regression will examine the relationship between vegetable consumption and changes in weight, BMI, and fat mass. This study aims to assess the impact of daily non-starchy vegetable intake on the weight, BMI, and fat mass of the overweight and obese university population.

Screening for Malnutrition in Obese Patients

More than half of the Dutch population is overweight or obese, which is associated with an increased risk of COVID-19 and worse outcomes during a COVID-19 infection. In addition, malnutrition and loss of muscle mass are often reported with COVID-19, as well as with cancer and other diseases. Malnutrition and overweight or obesity can coexist, even within the same individual. It is still unclear which mechanisms contribute to the worse outcomes of COVID-19 and other diseases in case of overweight, malnutrition, and a combination of both. The aim of this study is to identify which parameters are associated with worse disease outcomes through literature research and database research (COVID-19 and cancer, more than 150.000 participants). In addition, a clinical study will be conducted aiming to develop a simple screening tool for the recognition of the coexistence of malnutrition and overweight or obesity in clinical practice.