Clinical Research Directory

The Impact of Semaglutide Compared to Energy Restriction on Type 2 Diabetes

To evaluate the effects of subcutaneous injection of semaglutide for 12 weeks on patients with type 2 diabetes mellitus (T2DM), compared with concurrent energy-restricted management, on glycemic control, weight loss, inflammatory markers, liver fat content, and other parameters. The study also observed the subcutaneous and visceral fat of the participants and explored the molecular mechanisms of action, providing high-quality evidence-based support for the timing and targets of intervention in this population.

BRAHMS: Bed Rest And HypoMetabolism Study

The goal of this single arm, interventional monocentric clinical trial is to investigate the physiological effects of a combination of head-down bedrest and caloric restriction on the human body. A set of measurements will assess the changes in the musculoskeletal, cardiovascular, hematological, immune, neurological, cognitive and metabolic systems, in 10 healthy male volunteers. The main question it aims to answer is: what are the physiological responses to fasting in a microgravity environment? In an exploratory study such as this one, where many physiological systems are explored, it is difficult to select a single important endpoint. However, given the known effect of both caloric restriction and head-down bedrest on muscle loss, and its critical importance for the success of space missions, lean body mass, as assessed by DEXA, was chosen as the primary endpoint. The secondary endpoints are: * Cardiovascular, muscular, neuro-vestibular and neuropsychological functional performance * The onset of clinical symptoms and biological changes Participants will be exposed to a microgravity analog model (head down bed rest) and controled caloric restriction environment for 10 days, multiple physiological assessments will be performed during this period. Followed by a rehab period before leaving the study.

The Effect of Ketogenic-caloric Restricted Diet on Metabolic Endotoxemia in Prediabetic Obese Adults

Insulin resistance increases the risk of type 2 diabetes and cardiovascular disease, with gut dysbiosis emerging as a contributing factor. Metabolic endotoxemia, characterized by elevated serum lipopolysaccharides (LPS), disrupts insulin signaling via inflammatory pathways. While dietary interventions may lower LPS levels and improve insulin resistance, evidence on the effectiveness of ketogenic diet in this context remains limited. This randomized controlled trial aims to assess the effects of a ketogenic-caloric restricted diet on metabolic endotoxemia, measured by serum LPS levels, in prediabetic obese Jordanian adults aged 18-40 years in Amman over 12 weeks. Ninety participants will be randomly assigned to one of three groups (n=30 each): a ketogenic-caloric restricted diet, a normal-fat caloric restricted diet, or a control group (normal-fat without caloric restriction). Anthropometric parameters and dietary intake will be evaluated at baseline, week 6, and week 12. Blood samples will be collected at baseline and week 12 for measuring fasting glucose, insulin, LPS, inflammatory cytokines. Dietary adherence will be monitored through food records. This study aims to provide new insights into the role of dietary interventions in modifying metabolic endotoxemia and improving insulin resistance.

The Effect of Time Restricted Eating on Glycemic and Proinflammatory Biomarkers Among Prediabetic Obese Jordanian Adults Aged 18-40 Years Old

Obesity, a global epidemic, significantly contributes to prediabetes, cardiovascular diseases, and other chronic diseases due to its pro-inflammatory nature. This studyl investigates the effects of time-restricted eating (TRE) with calorie restriction (CR), TRE without CR, and CR without TRE on glycemic control and pro-inflammatory biomarkers among prediabetic obese Jordanian adults aged 18-40 years. The study assesses changes in pro-inflammatory biomarkers (IL-1β, TNF-α, IL-6), insulin resistance (HOMA-IR), and body composition over 12 weeks. Participants (n=120) will be randomized into four intervention arms: (1) TRE with CR, (2) TRE without CR, (3) CR without TRE, and (4) a control group with no dietary restrictions and no TRE. Biweekly anthropometric assessments will evaluate pro-inflammatory biomarkers and biochemical measures at baseline and the end of the study. The findings will provide insights into the comparative effectiveness of TRE and CR, potentially offering a safe, cost-effective intervention to prevent obesity-induced inflammation, prediabetes, and progression to type 2 diabetes mellitus.

Calorie Restriction in Multiple Sclerosis

There is a strong relationship between metabolic state and immune tolerance through a direct control exerted on immune cells by specific intracellular nutrient-energy sensors. An increased "metabolic work load" represents a novel issue linking metabolism with loss of self-immune tolerance. Several disease-modifying drugs have been approved for Relapsing-remitting Multiple Sclerosis (RR-MS) treatments and have shown to reduce relapse rates by modulating immune responses; however, their impact on long-term disease progression and accrual of irreversible neurological disability remains largely unclear, underlining the need for novel therapeutic strategies. In this context, both acute fasting (AF) and chronic caloric restriction (CR) have been shown to improve experimental autoimmune encephalomyelitis (EAE). Despite this evidence, no specific studies have been performed to dissect at the cellular level the mechanism of action of CR in the context of autoimmunity and MS. This study aims at investigating this specific point in order to pave the way for a wider utilization of a nutritional approach to alter MS progression and activity. The aim of this study is to improve the outcome of RR-MS and the efficacy of first line drug treatments (ie. Copaxone or Tecfidera) by altering the metabolic state of the host via calorie restriction with the aim to re-equilibrate immune/inflammatory responses of patients.