ANZCTR search results

Recent studies have demonstrated that calcium, in the doses of 500 mg and 1000 mg, stimulates gut hormones and pyloric pressures and suppresses energy intake. Given the key role of these GI hormones and pyloric pressures in the regulation of gastric emptying, which in turn is a key determinant of the lowering of blood glucose after a meal, we propose to investigate the dose-related effects of intraduodenal calcium infusion on gastric emptying, glucoregulatory hormones, and blood glucose in response to a mixed-nutrient drink in healthy participants.

The objective of this study is to determine if the use of Mastisol Liquid Adhesive in conjunction with standard care reduces dressing disruption prior to scheduled weekly dressing change and is associated with fewer CVAD complications in children receiving in-home care.

Chronic kidney disease (CKD) is a progressive condition associated with reduced quality of life, high mortality, and healthcare costs. The chronicity of this disease necessitates individuals actively self-manage their health care to maximise health outcomes. The term ‘patient activation’ explicitly identifies the skills, knowledge and confidence that underpin a person’s willingness and ability to self-manage their health Our recent survey of South Australian people with CKD stage 5 not receiving dialysis showed that most (73%) patients had low patient activation levels. Low patient activation levels were associated with more hospital emergency department visits and poor medication adherence. Given the current low patient activation levels, we co-designed with renal consumers and clinicians a Self-Management of Kidney Disease Program (S-Manage KD) that will be tested for feasibility and acceptability in this study. This SManage-KD program could significantly increase engagement in positive health behaviours for a more active role in self-management in the CKD population. It is hoped that this newly developed SManage-KD Program will increase patients' ownership of care required to reduce the burden in the transition to dialysis initiation, improve treatment adherence, reduce hospital admissions rate, and ultimately, costs downstream in the CKD population. To assess these outcomes a new study to assess the effectiveness of this program is required.

Transcendental Meditation (TM) may help prevent psychological distress while promoting mental and cardiometabolic health, but its effects remain underexplored among university staff in Australia. This two-arm, parallel-group randomised controlled trial at RMIT University will compare the effects of TM with access to the university's wellbeing program on psychological and cardiometabolic outcomes. Over 12 months, data will be collected three to four times through surveys, physical measurements (e.g., blood pressure, anthropometry), tracking using Biostrap Kairos watches (e.g. heart rate, sleep), biochemical assessments (e.g., lipid profiles, salivary cortisol, markers of insulin resistance and inflammation, telomere length), and interviews. The study aims to provide empirical evidence of TM's role in enhancing the mental and cardiometabolic health of university staff.

This research project will investigate the effects of daily almond protein supplementation on muscle mass, strength, body composition, and metabolic health in postmenopausal women (aged 50-65) undergoing a 10-week progressive resistance and high-intensity interval training (HIIT) program. The study aims to test the hypothesis that almond protein, a plant-based protein source, can enhance muscle hypertrophy, strength, and improve metabolic outcomes (e.g., glucose tolerance, blood lipids) when combined with resistance training.

People accessing alcohol and other drug (AOD) treatment experience high rates of loneliness. Groups for Belonging is a novel 6-session (2-hours per session) group-based loneliness intervention informed by cognitive and social identity theory, and shaped by lived experience consultation where the specific social needs of people with substance use disorders were identified. This includes the need to address stigma associated with substance use, and to target social anxiety and mistrust. The Building Belonging Project aims to determine the effectiveness of Groups for Belonging for people accessing residential and community-based treatment services for AOD use. If the intervention is effective and cost-effective, implementation efforts will focus on embedding the intervention into routine care in AOD treatment services across metropolitan and rural areas in Australia. This has significant potential to improve decrease loneliness and its associated effects on health and wellbeing for people accessing AOD treatment.

Many people with hypothyroidism do not feel well, even when their blood tests say their thyroid levels are normal. Apart from thyroxine, there are no other approved medications available to treat hypothyroidism. Naltrexone, a medication typically used to treat other conditions, may help people with hypothyroidism feel better when taken at a low dose. The purpose of this study is to determine whether naltrexone is beneficial when used in addition to thyroxine for the treatment of hypothyroidism. Our proposed study will test if naltrexone improves quality of life and other health related measures versus a placebo tablet. This will help us to understand whether this medication (naltrexone) should be studied further as a potential treatment for hypothyroidism. Medications must be approved for use by the Australian Federal Government. Naltrexone is currently approved in Australia to treat alcohol and opioid dependence. However, it is not approved to treat hypothyroidism. Therefore, it is an experimental medication for treatment of hypothyroidism secondary to Hashimoto’s thyroiditis. This means that it must be tested to see if it is effective for this indication.

The purpose of this study is to test the hypothesis that it is feasible and safe to use the Nutromics Sensor Device (investigational device; further called ‘Device’ in the protocol) to continuously monitor vancomycin concentrations in the interstitial fluid of intensive care unit (ICU) patients. This is a multi-site, mixed methods study consisting of a prospective observational study (Part 1) and survey with healthcare professionals (Part 2). The overall study duration is expected to be 18 months. Part 1 involves the application of two Devices over a period of 24 hours, and the comparison of the vancomycin concentrations measured by the device to those measured in plasma from blood samples. This 24 hour period of observation will be repeated on two occasions. These 24 hour periods of observation do not need to be sequential. In addition, assessment of Device safety will be determined. Associations between vancomycin concentrations measured by the Devices and treatment efficacy/safety up to 30 days post cessation of the course of therapy or post ICU discharge; whichever is sooner, will be determined from medical records. Part 2 involves the completion of a survey by stakeholders (physicians, pharmacists and nurses) involved in the use of the Device and thematic analysis of responses.

In this randomised, double-blind, placebo-controlled study, 60 generally healthy adults aged 18 to 65 experiencing high stress will be randomly assigned to receive an ashwagandha extract (NRAHG001) or a placebo for 28 days. Changes in self-reported stress, mood and fatigue will be measured over time. Moreover, changes in the stress response using subjective and physiological measures after exposure to an experimental stress procedure (Socially Evaluated Cold-Pressor Test) will be investigated. The effects of ashwagandha supplementation on metabolomic markers will also be investigated to help understand the mechanism of action associated with ashwagandha supplementation. It is hypothesised that ashwagandha will be associated with a reduction in self-reported stress, and improvments in overall mood and fatigue.

This is a double-blind, randomized, placebo-controlled study to assess XW10508 safety, tolerability and efficacy in patients with Major Depressive Disorder. Patients will be randomized to receive 200 mg once per week for 4 weeks. The hypothesis is that oral XW10508 tablets will rapidly improve and maintain the treatment of depression symptoms without significant adverse effects and with good patient tolerability.