Clinical Research Directory

Smartwatch-based Intervention for Cardiovascular Health (SWITCH)

This study aims to employ a cluster randomized controlled trial to evaluate the effectiveness of an mHealth-Based Multi-faceted Cardiovascular Health Intervention Model among Overweight/Obese Individuals with Cardiometabolic Preconditions, thereby providing theoretical foundations and practical guidance for the prevention and management of this population.

Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents: a Randomized Controlled Trial With Long-term Follow-up

The main purpose is to investigate the effectiveness of a 10-week multicomponent camp intervention to reduce BE behavior in children and adolescents and explore in a randomized controlled setting if a parent-based BED-intervention has any add-on effect, attenuating the development of BE behavior in this sample. The study will include an initial follow-up assessment scheduled 10-12 weeks after camp completion and plans for long-term follow-up assessments one, three and five years after inclusion. Overall, we hypothesize that the multicomponent camp intervention will effectively reduce BE behavior in children and adolescents. Furthermore, we hypothesize that participants whose parents are randomized to receive the parental BED intervention will show a lower prevalence of BE behavior one year after the camp intervention compared with children whose parents receive standard care.

Real-world Effectiveness and Dosing Patterns of Tirzepatide in People With Obesity

Tirzepatide is one of the new medications for the treatment of obesity. In clinical research people treated with Tirzepatide have weight loss up to 21%. But there is only a little bit of research showing the effect of Tirzepatide in clinical practice. In this retrospective observational study the investigators will evaluate the effectiveness of tirzepatide in routine clinical practice among adults with obesity in the Netherlands.The main questions it aims to answer are: * How much weight do patients lose after six months of treatment with tirzepatide combined with lifestyle coaching? * How is the medication dosed in daily practice? Researchers will use data from electronic health records of patients in multiple outpatient locations of the Dutch Obesity Clinic (NOK, Nederlandse Obesitas Kliniek).

Comparing Outcomes Among Children With Obesity in a Community Healthy Lifestyle Program

This study aims to evaluate the outcomes of an existing clinical program that teaches families of children with overweight and obesity healthy lifestyle. The design will be unblinded, randomized, waitlist control.

Efficacy and Safety of ZT006 in Overweight and Obese Participants

This study is being conducted to evaluate the efficacy and safety of ZT006 tablet in participants with overweight and obesity. In addition to dietary caloric restriction and increased physical activity, study participants will receive either ZT006 tablets or placebo tablets once every morning (placebo looks like ZT006 tablets but has no active pharmaceutical ingredients). For a fair comparison, study participants are assigned to ZT006 or placebo randomly by a computer. The treatment will last for 28 weeks. ZT006 tablets will be administered in an up-titration fashion, i.e. the dose of ZT006 will be gradually increased to reach three target doses so that the participants can tolerate its effect. Participants will have 17 clinic visits including one screening visit and one follow-up visit. Female participants who are pregnant, breast-feeding or who plan to become pregnant during the study are not allowed to participate in the study. Pregnancy will be checked by blood or urine tests during the study.

Metformin Combined With Secukinumab for Moderate-to-Severe Plaque Psoriasis in Overweight or Obese Chinese Patients

This is a randomized, double-blind, placebo-controlled, multicenter clinical trial conducted in China. The study aims to evaluate the efficacy and safety of metformin combined with secukinumab in the treatment of moderate-to-severe plaque psoriasis in overweight or obese Chinese patients. A total of approximately 186 participants will be enrolled and randomly assigned in a 1:1 ratio to receive either secukinumab plus metformin or secukinumab plus placebo. The study consists of a screening period, an induction period, a maintenance period, and a follow-up period, with a total duration of 60 weeks. The primary endpoints are the proportions of participants achieving PASI75 (≥75% improvement in Psoriasis Area and Severity Index) and an IGA score of 0 or 1 (clear or almost clear) at Week 24. Secondary endpoints include PASI90, quality of life (DLQI), pruritus NRS score, metabolic parameters, and safety assessments. This study aims to provide a more effective combination therapy for psoriasis patients with overweight or obesity.

A Study to Evaluate the Safety, Tolerability, Pharmacokinetics, and Pharmacodynamics of a Single Dose of IBIO-600 in Overweight or Obese Adults

The goal of this clinical trial is to learn which dose of study drug IBIO-600 has the right balance of safety, tolerability and impact on body composition in overweight and obese adult participants.

A Randomized, Double-Blind, Placebo-Controlled Study Evaluating the Impact of CLB101TM️ on Gut Health in Healthy, Overweight Individuals

Anaerostipes caccae CLB101TM️ is a next-generation probiotic isolated from healthy humans. It was shown to be in decreased abundance in people with protein-based food sensitivities/allergies. CLB101TM️ is different from most commercially available probiotics in that it directly produces butyrate. Butyrate is a naturally occurring small molecule found in the gut of healthy individuals, and it has been shown to provide clinical benefits including strengthening the gut lining, providing immune health, and supporting a balanced microbiome. The rationale for developing CLB101TM️ is to provide a probiotic that generates butyrate in the targeted intestinal locations where it can optimally benefit cells that line the gut.

BfedBwell INSPIRE Pilot

This single-arm pilot study will evaluate the feasibility and acceptability of a comprehensive survivorship lifestyle intervention addressing nutrition, exercise, sleep health, and stress management. The intervention integrates the BfedBwell survivorship nutrition program with the BfitBwell clinical exercise oncology program. The augmented BfedBwell program includes: (1) a core education curriculum, (2) 1:1 counseling with a registered dietitian, (3) behavioral skills development, (4) group support, and (5) commercially available wearable technology and smart scales for self-monitoring of physical activity, sleep, and body weight.

Study on the Efficacy of Probiotics in the Treatment of Childhood Obesity and Their Effects on Gut Microbiota

This interventional study aims to evaluate the efficacy of a probiotics supplementation (Bifidobacterium longum subsp. longum Dipro-O and Bifidobacterium longum subsp. longum Dipro-X; dipro Gracfor PROBIOTICS FAST MELT) in treating childhood obesity and its impact on gut microbiota. The study will enroll 60 overweight or obese children aged 3 to 14 years. Participants will be randomly assigned to either a treatment group receiving lifestyle intervention combined with an oral Bifidobacterium preparations for 8 weeks, or a control group receiving lifestyle intervention alone. The primary outcome is the change in sex-specific BMI-for-age percentiles. Secondary outcomes include changes in height, weight, waist circumference, quality of life satisfaction, and alterations in gut microbiota composition analyzed via 16S rRNA gene sequencing.

High Phenolic Olive Oil for Enhancing Metabolic Health: a Randomized-controlled Trial in Patients With cEntral Obesity (HOPE)

Olive oil is a fundamental component of the Mediterranean diet and a major source of monounsaturated fatty acids with well-established cardioprotective properties. When rich in phenolic compounds-such as hydroxytyrosol, tyrosol, oleuropein, oleocanthal, oleacein, and ligstroside aglycone-it is considered a functional food with antioxidant, anti-inflammatory, cardioprotective, chemoprotective, and neuroprotective effects. According to EU Regulation 432/2012, daily consumption of 20 g of extra virgin olive oil containing at least 5 mg of hydroxytyrosol and tyrosol derivatives (250 mg/kg) contributes to the protection of blood lipids from oxidative stress and qualifies for a health claim. Overweight/obesity, characterized by excessive fat accumulation, is strongly associated with non-communicable diseases, including cardiovascular disease, type 2 diabetes, hypertension, certain cancers, and neurodegenerative disorders. Chronic low-grade inflammation and oxidative stress are key mechanisms underlying obesity-related metabolic disorders. Although dietary energy restriction remains the primary approach for weight management, growing research interest focuses on natural products rich in phenolic compounds as potential modulators of molecular pathways involved in central obesity. However, robust clinical evidence in humans with central obesity and metabolic abnormalities remains limited. Therefore, this double-blind, randomized, controlled trial aims to investigate the effects of extra virgin, high-phenolic olive oil (HPOO) compared with low-phenolic olive oil (LPOO) in adults with overweight/obesity with metabolic abnormalities. Participants will consume the assigned olive oil type (HPOO or LPOO) for eight weeks. At baseline and trial endpoint (8 weeks), data collection will include anthropometric measurements, dietary intake, biochemical indices, inflammatory and oxidative stress markers in blood samples, hormones, bioavailability of phenolic compounds, as well as lifestyle parameters i.e., health-related quality of life, physical activity levels, sleep quality. Ethical approval, informed consent, and data protection procedures will be strictly followed. Statistical analyses will be conducted using SPSS software (SPSS Inc, ΙΒΜ, Chicago, IL, USA). The study is anticipated to explore whether consumption of high-phenolic olive oil favorably modulates markers related to obesity and metabolic abnormalities, while also improving nutritional status and quality-of-life parameters.

A Study of Zovaglutide (ZT002 Injection) in Participants With Impaired Kidney Function and Healthy Participants

This study is a single-dose, open-label, parallel design phase I clinical study to evaluate the PK characteristics and safety of single subcutaneous injection of ZT002 Injection in participants with different degrees of renal insufficiency and matched participants with normal renal function.

Mapping Metabolic Organ Plasticity in Energy Adaptation

Brief Summary (Plain Language) Many people who lose weight experience a slowdown in their metabolism that is greater than expected. This response, called metabolic adaptation, makes it harder to continue losing weight or to keep weight off over time. The biological reasons for this slowdown are not fully understood. Some organs in the body, especially the liver and kidneys, use a large amount of energy even when the body is at rest. Although these organs make up only a small portion of body weight, they account for a large share of daily energy use. Changes in the size or function of these organs may play an important role in metabolic adaptation, but this has not been well studied in humans. The purpose of this study is to understand how different lifestyle approaches affect metabolic adaptation and the size of key metabolic organs. Specifically, the study compares three common strategies: * resistance training without calorie restriction, * a calorie-restricted diet, and * time-restricted eating (eating all daily food within a limited time window). Adults with overweight will take part in one of these approaches for 10 weeks. Before and after the study period, participants will undergo advanced measurements, including magnetic resonance imaging (MRI) scans to measure liver and kidney size, tests to measure resting metabolism, and assessments of body composition. Some participants will also undergo additional testing to measure daily energy use. By understanding how different lifestyle strategies influence metabolism and organ size, this study aims to improve knowledge about why weight loss is difficult to maintain and to support the development of more personalized approaches to long-term weight management.

Improving Weight Loss in Healthy Adults With Overweight and Obesity: An Artificial Intelligence-assisted Dietary Prediction and Prevention System With Continuous Glucose Monitoring

This study aims to examine the effectiveness of a novel dietary lapse prediction and prevention self-regulation app called the eating behaviour trigger-response inhibition program (eTRIP), and the addition of continuous glucose monitoring (CGM), on healthy eating and weight loss in people with overweight and obesity.

Community Physical Exercise Program in Chronic Disease

This study focuses on promoting physical activity (PA) through the implementation of a Community Physical Exercise Program for Chronic Diseases (CPEP-CD), targeting individuals aged 50 years and older with at least two of the following conditions: cardiovascular and/or cerebrovascular disease or risk (CVD), overweight, diabetes mellitus (DM), and musculoskeletal diseases. The primary objective is to improve muscle and cardiorespiratory health and well-being, while also contributing to a more objective and evidence-based exercise prescription for these pathological conditions. Population ageing is a global challenge associated with an increased prevalence of chronic diseases that compromise quality of life (QoL). A sedentary lifestyle is linked to declines in muscle function and cardiorespiratory fitness and is considered a major risk factor for morbidity and mortality. Consequently, physical exercise is widely recommended as a key non-pharmacological intervention across multiple chronic diseases. According to World Health Organization (WHO) guidelines, regular PA is a protective factor in the prevention and management of non-communicable diseases, including cardiovascular and cerebrovascular diseases and DM. In addition, PA provides mental health benefits, supports healthy weight maintenance, and enhances overall well-being. In adults, regular PA is associated with reductions in all-cause mortality, cardiovascular mortality, and the incidence of hypertension. Within this context, the aim of this project is to implement a community-based physical exercise program for individuals with chronic disease and multimorbidity, focusing on CVD and cerebrovascular disease or risk, DM, and OA. The program integrates existing exercise prescription guidelines while personalizing exercise progression according to both disease-specific and multimorbidity profiles. The primary outcomes include improvements in cardiorespiratory fitness, muscular strength, bone health, functional capacity, and QoL. Additionally, through individualized training monitoring, this study seeks to establish an exercise prescription tailored to the most prevalent combinations of chronic diseases, thereby providing more objective and practical guidance for family physicians, exercise professionals, and rehabilitation specialists, and supporting more personalized and targeted exercise-based strategies for chronic disease prevention and management.

Exercise, Chronotype, and Prediabetes

The goal of this clinical trial is to find out whether exercising at the right time of day, based on a person's natural body clock, leads to greater health benefits in people living with prediabetes. The main question it aims to answer is whether doing a single session of exercise in the morning or in the evening affects how the body handles sugar differently in adults with prediabetes who have an extreme natural body clock. This will be done by comparing three conditions (no-exercise, morning exercise, and evening exercise) within the same participant. Each condition will be tested on a different day, with at least 14 days between the test days. During the no-exercise test days, participants will come to the study centre and will only be allowed to do sedentary activities (e.g. office work, reading, or screen time). During the morning exercise test days, participants will perform an exercise session at 9:00 am that involves short periods of very hard effort followed by short rest periods. Whereas for the evening exercise test days, the same type of exercise will be performed at 5:00 pm.

Efficacy and Safety of Akkermansia Muciniphila AKM Lab-01 for Overweight and Obesity

This study is designed as a preliminary investigation to evaluate the weight-loss efficacy and safety of AKM Lab-01 in an overweight or obese population. It is an interventional, radomized, double-blind, placebo-controlled clinical trial. Participants who meet the eligibility criteria will be randomly assigned to receive AKM Lab-01 or a matching placebo. The intervention will be administered once daily for 3 months. Baseline metrics, along with blood, urine, and stool samples, will be collected from participants, before and after the AKM Lab-01 intervention. The analysis will focus on changes in body weight, blood lipids, blood glucose, and gut metagenomic profiles (from stool samples). Furthermore, metabolomic analysis of blood and stool samples will be conducted to explore the potential machanisms through which AMK Lab-01 influences body weight.

Asiaticoside for Treating Overweight/Obesity

Centella asiatica is a traditional herbal medicine widely used in China and Southeast Asia for treating various conditions. Preclinical studies have shown that madecassic acid glycosides, including asiaticoside and madecassoside, can significantly reduce body weight gain, adipose tissue mass, and serum triglyceride levels in high-fat diet-induced obese mice. These compounds also improve hepatic steatosis and insulin resistance. This exploratory, interventional study aims to evaluate the clinical efficacy of orally administered asiaticoside tablets in adults with overweight or obesity.

A Study of Zovaglutide in Subjects With Overweight or Obesity (HORIZON-1)

This study will evaluate the percentage change in body weight from baseline and proportion of subjects achieving ≥ 5% weight loss from baseline after 52 weeks of treatment with Zovaglutide in subjects with overweight/obesity.

Immediate Effect of Whole-Body Vibration on Cardiovascular Response and Functional Capacity in Overweight/Obese Young Women

Obesity has become a major global public health issue, defined by an excessive accumulation of body fat that presents substantial health risks. Over 650 million adults worldwide suffer from obesity, which is defined as having a Body Mass Index (BMI) of 30 or higher. Obesity is becoming more common in both developed and developing countries. Sedentary lifestyles, unhealthy eating habits that include processed foods and sugars, and genetic factors are the main causes of the rising prevalence of obesity. Obesity is a multifactorial condition that affects physical appearance and self-esteem, while also having significant implications for long-term health, leading to decreased life expectancy and lower quality of life.

Dietary Guidelines for Americans-Ultra Processed Study

The purpose of this research is to test how processing food can affect how one's body responds to it.

A Study on the Effectiveness of Comprehensive Intervention Based on Specialized Physical Education Courses in the Prevention of Comorbidity Among Junior Middle School Students

Junior high school students are in a critical period of physical and mental development, currently facing two major health challenges: first, persistently high rates of myopia with a noticeable trend toward younger onset; second, the overlapping occurrence of common conditions such as overweight/obesity, spinal deformities, and psychological anxiety.Traditional physical education classes, characterized by limited content and insufficient targeting, struggle to address these issues. Multimorbidity of common diseases in children and adolescents refers to the coexistence of two or more common diseases or chronic health problems in the same individual. Therefore, this study innovatively designed a specialized physical education curriculum integrating "exercise + health education," aiming to fill the gap in comprehensive prevention and control of common adolescent health conditions through traditional physical interventions. This study systematically investigated the effects of a specialized physical education intervention program on myopia prevention and control, as well as the simultaneous prevention of multiple common health conditions (overweight/obesity, abnormal blood pressure, insufficient cardiorespiratory fitness, abnormal spinal curvature, anxiety symptoms, and depression symptoms) among junior high school students in China. The program was designed and implemented for students at a Chinese secondary school, ultimately aiming to provide a replicable school-based physical education intervention model for adolescent health promotion. The study strictly adhered to a randomized controlled design, employing multidimensional evaluation, long-term follow-up, and rigorous quality control to ensure scientific validity and reliability of the findings.