ANZCTR search results

In some people, blood glucose levels become low (‘hypoglycaemic’) after a meal and cause symptoms such as shakiness, sweatiness and difficulty concentrating. These symptoms can be bothersome and may be severe. Current approaches to manage this condition, so-called ‘idiopathic reactive hypoglycaemia’, are limited as we do not know what is causing the blood glucose level to drop. When food passes through the intestine, various ‘hormones’ that influence blood glucose levels enter bloodstream. While this is a useful to prevent an abnormal elevation in blood glucose after a meal, we think individuals who have low blood glucose levels after eating may have abnormally fast movement of food through the stomach and intestine leading to increased release of these ‘hormones’. This study is designed to investigate this possibility and if shown to be the case, this would provide a basis for logical, and hopefully, more effective treatment for ‘idiopathic reactive hypoglycaemia’.

Non-alcoholic steatohepatitis (NASH) is an advanced form of non-alcoholic fatty liver disease (NAFLD). NAFLD is caused by a build-up of fat in the liver. This build-up causes inflammation and damage, known as NASH, leading to scarring of the liver and developing the life-threatening condition of cirrhosis. There are no medicines currently approved for the treatment of NASH. Current treatments include dietary changes, weight loss, increased exercise and treatment of associated dyslipidaemia and metabolic syndrome. Recent studies suggest that lifestyle changes (nutritional counselling and exercise) with or without 100mg per day of a mixed tocotrienol product for 3 months showed a decrease in liver stiffness. 79% of those who improved were from the tocotrienol group and 21% from the lifestyle only group. This study will compare treatment with the tocotrienol, TransT3-60, a sublingual powder, to matching placebo, to compare the effects on liver structure measured by ultrasound and magnetic resonance imaging. Safety assessments will be conducted at baseline and 4 weekly intervals. A total of 80 participants will be randomly allocated (1:1) to either the tocotrienol treatment (TransT3-60) or to the placebo group for 24 weeks.

Sleep is important for the optimal health and performance of an athlete. Data suggests that as sleep debt accumulates, sports-related performance is further reduced. Athletes with sleep difficulties are prone to accumulating sleep debt and are therefore of greater risk of impaired performance. This athlete cohort need sleep intervention, with recent research indicating diet influences an athlete’s sleep. Protein supplements high in the amino acid tryptophan may promote sleep through increases in melatonin, with individuals experiencing sleep difficulties believed to be more receptive to the sleep-promoting benefits of tryptophan. Therefore, this study aims to investigate the effect of a potentially sleep-promoting protein supplement (alpha-lactalbumin) on the sleep and performance of athletes with sleep difficulties.

We will evaluate, in a proof-of-concept trial, whether exclusion of FEW-containing foods which are commonly reported as triggers in CD is efficacious in maintaining remission in patients. The study design will be a randomised controlled trial of the FEW foods exclusion diet compared to standard IBD dietary management. The primary outcome for this study is the composite intestinal ultrasound and faecal calprotectin. We predict that the diet low in fats, emulsifiers and wheat will maintain IBD remission for longer than the enhanced standard care diet

We hypothesize that concussion will alter the amplitude and frequency characteristics of measured head movements induced by cerebral blood flow during a cardiac cycle, and that it will be feasible to measure these changes using a non invasive, external device at various timepoints after concussion. We will evaluate the feasibility of using a novel, external cranial accelerometry device for individuals with concussion. Specifically we will determine the practicality of obtaining head pulse recordings at various time points after injury and during recovery from concussion.

Low muscle mass (sarcopenia) is emerging as a significant risk factor for non-alcoholic fatty liver disease (NAFLD) and there is evidence to suggest this risk may be even higher in those with obesity. While weight loss, through hypocaloric diets and aerobic exercise is currently the mainstay of NAFLD prevention and management a concurrent loss of muscle (lean) mass often occurs with this approach. Studies conducted in non-NAFLD participants have indicated weight loss in conjunction with a higher protein intake and/or progressive resistance training (PRT) may improve or attenuate the associated loss of muscle (lean) mass during weight loss interventions. Yet, no study to date has assessed the feasibility of a higher protein intake from predominately plant-based sources in conjunction with exercise incorporating AT plus PRT in a NAFLD cohort. Uptake and adherence to community and clinic-based exercise programs is typically poor. Telehealth has emerged as an encouraging intervention delivery method to expand participant reach and accessibility by shifting treatment from clinics and hospitals to patients’ homes for people with chronic disease such as NAFLD and T2D. For example, telehealth facilitates contact to and overcomes several barriers to traditional exercise and nutrition interventions, including access to evidence-based programs anytime and anywhere, cost, transport and issues related to geographical location. Furthermore, telehealth allows regular follow-ups with healthcare professionals and can be individualised according to each patient’s needs. However, few lifestyle focused telehealth programs have been conducted in NAFLD cohorts, and before they can be widely implemented further research is required required to assess the feasibility, adherence, and effectiveness of telehealth as a model of healthcare delivery for people with NAFLD . Therefore the aim of this 12-week randomsied controlled trial is to evaluate whether a telehealth intervention focused on increasing daily protein intake (predominately from plant-based sources) combined with a smart device exercise app to promote regular muscle strengthening exercise is safe and feasible for middle aged and older adults with NAFLD. Secondly, whether the above mentioned telehealth lifestyle intervention can improve lifestyle behaviours related to overall physical activity and diet quality and functional muscle strength.

This study aims to develop, implement and pilot a parent-based intervention called Parents in Play (PiP) for enhancing pre-school children’s self-regulation. PiP is designed to support parent-child play to foster children’s self-regulation. This randomised control trial (RCT) pilot evaluation seeks to investigate the effects of PiP on parents’ autonomy supportive guiding behaviours, as well as on children’s self-regulation during everyday play activities.

This is a single arm prospective trial that will evaluate the ability of a novel imaging agent (68Ga-NTA-14) to detect metastatic castration resistant prostate cancer cells within the prostate and other tissues. Who is it for? You may be eligible for this study if you are a male aged 18 years or older and you have been diagnosed with prostate cancer that is metastatic and castration resistant (has not responded to surgical removal). Study details Participants who choose to enrol in this study will receive a single administration of 68Ga-NTA-14 (into a vein) 1 hour prior to Positron Emission Tomography (PET)/Computed Tomography (CT) imaging on Day 1. Between Day 3-8, a single administration of 68Ga-PSMA I&T will be administered (into a vein) 1 hour prior to PET imaging. PET/CT scans will be performed at 1 hour and 3 hours after administration of NTA-14 imaging agent and 1 hour after 68Ga-PSMA imaging agent. Participants will undergo safety monitoring which will include assessment of any side effects at 4 hours after administration of 68Ga-NTA-14. Participation will require up to 8 days including screening (Day -30 to 0), imaging with 68Ga-NTA-14 (Day 1), and imaging with 68Ga-PSMA I&T (Day 3-8). Participants will be followed up 1 hr post 68Ga-NTA-14 administration for evaluation of side effects. It is hoped this research will demonstrate that 68Ga-NTA-14 can be administered to patients without serious side effects, and that the images produced by this agent will be similar to or of better able to detect metastatic castration resistant prostate cancer cells compared to 68Ga-PSMA I&T images.

Acute-on-chronic-liver failure has a rising global healthcare burden with both 28-day mortality and 30-day readmission rates greater than 30%. Compared to other chronic conditions, those with ACLF have reduced access to coordinated ambulatory care. LivR Well is a multidisciplinary, home-based liver optimisation program implemented in the first 28 days after an ACLF admission. Components will include pharmacy, dietetics, physiotherapy, neuropsychiatry and social work in addition to medical and nursing input. This randomised controlled trial aims to demonstrate an improvement in mortality and readmission through early intervention in this cohort.

This is first in human, study of Clofazimine (CFZ) inhalation suspension (MNKD-101) in healthy adult participants The study is comprised of two parts (Part A and Part B) to investigate the safety, tolerability, and pharmacokinetic of MNKD-101 Part A (Single Ascending Dose): There are total 3 cohorts in Part A of the study and each cohort will enroll approximately 8 participants Part B (Multiple Ascending Dose): There are total 2 cohorts in Part B of the study and each cohort will enroll approximately 8 participants Oversight of the study will be provided by a Safety Monitoring Committee (SMC) comprising the Investigator, the local Medical Monitor (MM), and the Sponsor’s Chief Scientific Officer (CSO). The total duration of participation in the study for each participant in Part A is up to 43 days, and up to 57 days for Part B, both inclusive of a Screening period of up to 28 days.