Clinical Research Directory

Testing the Efficacy, Safety, and PK of 20E in Patients With Obesity Who Are Starting Treatment With the GLP-1 Agonist Semaglutide for Weight Loss.

The goal of this clinical trial is to learn if BIO101 treatment can improve the muscle strength of participants males and females, aged 18 to 84 years old, suffering from obesity (BMI≥30) or overweight (BMI ≥ 27) with one or more sequelae (e.g., hypertension, dyslipidemia, obstructive sleep apnea or cardiovascular disease, but excluding diabetes), and treated with semaglutide, a GLP1 agonist for 21 weeks. The main questions it aims to answer are: * Is BIO101 administered orally improving muscle strength, as measured with knee extension strength (using isokinetic dynamometry)? * Is BIO101 administration leading to additional medical problems for patients suffering from obesity or overweight with sequelae and treated with semaglutide? After the end of the study (after last patient did the last visit at the clinic), researchers will compare the BIO101-treated arm to the placebo control arm to see if the candidate drug has an effect on muscle strength, physical function, lean body mass and health related quality of life compared to placebo. BIO101 is the candidate drug and placebo is a look-alike substance that does not contain any active drug Participants will be asked to: * Take 2 pills every morning and every evening of BIO101 or placebo orally for 21 weeks. * Simultaneously, take semaglutide for 21 weeks while being on caloric restriction, following the doctor recommendation and approved prescribing information for semaglutide, with dose increasing up to at least a dose level of 1.7 mg and a maximum dose level of 2.4 mg. * Come to investigational site at screening, baseline, week 6, 13, 21 and week 33 (12 weeks after the end of treatment) for checkups and tests. * Answer to phone calls at week 25 and 29 as well (4 and 8 weeks after the end of treatment) on global health status and quality of life.

The Effect of Repeated Whole-body NMES Sessions With or Without Protein Intake on Muscle Protein Synthesis During 3 Days of Bed Rest in Healthy Young Volunteers

The goal of this clinical trial is to examine the effect of whole-body electrostimulation with protein intake on muscle protein synthesis, muscle mass and function during bed rest in healthy young adults (18-35 years). The main questions to answer are: * Does whole-body NMES followed by protein intake improve muscle protein synthesis rates during 3 days of bed rest? * Does repeated NMES sessions offer protective effects on muscle mass and function during extended periods of inactivity? Researchers will compare sham electrical electrostimulation, electrical stimulation and electrical stimulation + protein groups to see if whole-body electrostimulation combined with protein intake offers the greatest improvement in muscle protein metabolism and muscle preservation. Participants will: * Undergo 3 days of bed rest while receiving one of the following interventions: * Sham-NMES followed by standard nutrition (CON) * Whole-body NMES followed by standard nutrition(NMES) * Whole-body NMES followed by a bolus of 20g protein (NMES+PRO) * Receive heavy water (D2O) to assess body water turnover. * Undergo leg extension exercises to assess muscle function. * Have quadriceps muscle thickness measured via ultrasound. * Provide saliva samples for analysis. * Have calf circumference measured to monitor changes in muscle mass.

Indicator Amino Acid Oxidation in ICU Patients

This study will use the indicator amino acid oxidation technique (IAAO) to determine protein oxidation of ICU patients at two protein intakes: 1.3 g/kg/d versus 2.0 g/kg/d.

Muscle and Subcutaneous Tissue Variation by Ultrasound and Impedance Linked to Fluid Balance in ICU Patients

This cross-sectional study aims to investigate the relationship between variations in muscle thickness and subcutaneous tissue, measured by ultrasound, and fluid compartments, evaluated using bioelectrical impedance analysis (BIA), in critically ill patients in the intensive care unit (ICU). Critically ill patients frequently experience muscle wasting and tissue edema due to a combination of inflammation, immobilization, and aggressive fluid resuscitation protocols designed to counteract hemodynamic instability. Ultrasound is widely used to monitor muscle thickness because it is fast, non-invasive, and repeatable. However, muscle thickness measurements during the first days of ICU admission may be influenced by fluid overload, which causes edema and might lead to an overestimation of actual muscle mass. Bioelectrical impedance analysis (BIA) is a complementary tool that assesses both intra- and extracellular fluid compartments. This study aims to correlate daily fluid balance with changes in muscle thickness and subcutaneous tissue measured by ultrasound, and to determine if BIA can accurately reflect fluid status and potentially identify edema in these patients. Furthermore, at ICU discharge, patients' muscle strength will be assessed using both the MRC-sum score (0-60) and handgrip strength (using a Jamar dynamometer), to investigate whether the presence of edema at discharge correlates with muscle strength deficits. Data collection will occur daily, tracking fluid balance, clinical parameters, and body weight, alongside ultrasound and BIA measurements in a standardized position. The study will help clarify the interactions between fluid management, muscle mass changes, and clinical outcomes in critically ill patients, providing valuable insight into early rehabilitation strategies.