Trowbridge

Researchers are investigating whether the medicine vicadrostat, when taken together with empagliflozin, can lower the risk of heart-related problems in adults who have type 2 diabetes, high blood pressure, and cardiovascular disease but no history of heart failure. This study is a Phase III trial that compares the effects of vicadrostat plus empagliflozin to a placebo plus empagliflozin in people with these conditions. Participants are randomly assigned to one of two groups: one group takes vicadrostat and empagliflozin tablets, and the other group takes placebo tablets that look like vicadrostat along with empagliflozin. All participants take one tablet daily for a period ranging from two and a half years up to four years and three months. Throughout the study, participants continue their usual medications for diabetes, high blood pressure, and cardiovascular disease. During up to 51 months of participation, participants visit the study site regularly where doctors collect health information and blood samples. Researchers track when participants experience cardiovascular events such as heart-related deaths or heart failure events. The study also monitors participants’ overall health and any side effects they may experience to assess the safety and effects of the treatments.

This research investigates the acceptability, compliance, and gastrointestinal tolerance of an upgraded formulation of Elemental 028 Extra, a nutritionally complete amino acid-based feed. It is designed for patients with severe impairment of the gastrointestinal tract, including those with inflammatory bowel disease, short bowel syndrome, malabsorption, allergic diseases, and neurodegenerative disorders. The study involves both adult and pediatric patients who require an elemental diet due to their medical conditions. Participants will receive the upgraded Elemental 028 Extra in either powder or liquid form. The case study lasts 29 days, starting with a 1-day baseline period followed by a 28-day intervention period during which the nutritional supplement is used as the sole source of nutrition to meet daily macronutrient and micronutrient needs. This study is conducted across multiple centers in the UK to meet UK ACBS and GMS requirements. During the study, researchers will record gastrointestinal tolerance at the start and end of the intervention. Participants' compliance and acceptability of the nutritional supplement will also be evaluated. The study aims to provide detailed observations on how well patients tolerate and adhere to the upgraded feed, helping to support dietary management for those with significant gastrointestinal impairment.

Researchers are evaluating whether a new plant-protein dominant blend in enteral tube feeds works as well as traditional animal-protein dominant feeds for adults who are tube fed at home. This exploratory randomized controlled trial includes a 3-day baseline period before starting the intervention. The study focuses on outcomes such as gastrointestinal tolerance, compliance, acceptability, body measurements, nutrient intake, and physical function over time. Participants will be randomly assigned to receive either one or a combination of four plant-protein dominant tube feeds or four animal-protein dominant control feeds. Both groups continue their current tube feed for 3 days during baseline, then switch to their assigned feed for 3 months. The feeds come in variations of 1kcal/ml or 1.5kcal/ml, with or without fiber. After the 3-month intervention, participants can join a 12-month follow-up with data collected at 6 and 12 months. A dietitian will determine each participant's feed prescription, ensuring a minimum of 500ml (500 kcal) daily. Throughout the study and follow-up, researchers will assess changes in gastrointestinal tolerance, acceptability, compliance, nutrient intake, body weight, height, calf circumference, and physical function tests like the 30-second chair stand and handgrip strength. Measurements will be compared from baseline through the end of intervention and after 12 months. This long-term monitoring aims to understand the effects of plant-protein dominant feeds on health and physical function in adults receiving enteral nutrition at home.