ANZCTR search results

The aim is to determine whether an insulin regimen specific for prednisolone-induced hyperglycaemia is safer and more efficacious than basal bolus insulin, the current regimen commonly used in many hospitals. As we have previously showm that prednisolone predominantly increases blood glucose between midday and midnight, we hypothesize that delivering the majority of insulin during this time period and less insulin between midnight and breakfast will reduce nocturnal hypoglycaemia and better treat postprandial hyperglycaemia.

This is a single-center study using a blood stage Plasmodium falcipaurm challenge (BSPC) inoculum to characterize the effectiveness of OZ439 against early Plasmodium falciparum blood stage infection. The study will be conducted in up to 3 cohorts using different doses of OZ439.

This study evaluates the sleep, stress and attachment outcomes for infants and parents undergoing behavioural interventions using a randomised controlled design.

Regulation of the factors that control food intake, the function of the stomach and small intestine and release of gut hormones is complex, and our understanding of this field is far from complete. There is increasing evidence that nutrient stimuli in the gut, especially in the small intestine, induce changes in gut motor and hormonal functions that play a central role in the control of energy intake and blood glucose. In particular high-protein diets have been found to be very effective for weight loss and for improving blood glucose in obese with and without type 2 diabetes. This study aims to investigate the effects of the amino acid, L-tryptophan, on gut motility, gut hormone release, blood glucose control and energy intake in humans. We hypothesise that L-tryptophan as building block of proteins, may substantially contribute to the beneficial effects of whole protein on gut functions and energy intake regulation. This has not been evaluated in detail and will be important in order to enhance our understanding of the mechanisms underlying the effects of dietary protein on eating control.

This research project is aiming to determine the effects of Bacopa on cognitive function, cardiovascular function and stress. Bacopa is a herb found in wetlands and muddy shore lines that has been used in traditional Indian medicine as a treatment for epilepsy and asthma. Russo & Borrelli (2005) claim that it has been used for over 3000 years as a memory and intellect enhancer. There is also evidence to suggest that Bacopa is an antioxidant, playing an important role in reducing the oxidation of fats in the bloodstream. This study will investigate the cognitive, cardiovascular and stress effects of a two doses of bacopa compared to placebo. Participants will be required to consume one of three treatments on each testing day, and will consume the other treatments on the other two days of testing. After the first battery of tests, each participant will be administered their treatment and have a two hour wait period. At the end of this period the participant will complete the second series of battery tests. There will be a seven day washout period and the process will be repeated again. (1) Bacopa – 320mg (2) Bacopa – 640mg (3) Placebo

We have previously demonstrated the effectiveness of a multidimensional assessment and individualised management approach in older people with obstructive airways disease, showing that such a programme leads to significant improvement in health outcomes. The current study aims to continue this new model of management in a different population of people with severe persistent asthma. People with severe persistent asthma continue to suffer a significantly high burden of disease despite maximal pharmacotherapy. Despite this, few trials seeking to improve management of severe asthma, have been performed. The current study aims to improve the management and outcomes for people severe persistent asthma, with the goal of reducing morbidity, improving health status and informing clinical guidelines. This study will aim to test a novel model of management in severe asthma using multidimensional assessment and individualised management (MDAIM) including inflammometry and case management. We hypothesize that treatment of severe asthma that is targeted to co-morbidities, inflammatory and other immunological biomarkers delivered using a case management approach will improve severe asthma outcomes specifically asthma control, exacerbations, medication use and health related quality of life.

Selenium (Se) - an essential trace micronutrient, and green tea - the most common beverage consumed worldwide, have numerous biological properties that may protect against various cancers, including colorectal cancer (CRC). Despite promising results in preclinical settings, current clinical trial data are not convincing enough to allow general recommendation for using Se or green tea as an effective agent for chemoprevention of cancer in humans. This is a pilot study on the possible effects of Selenium (Se) in preventing bowel cancer in healthy individuals. 3 or 4 of our staff members will take part in this trial, prior to the launch of a full study once results have been gathered from this pilot study. Who is it for? This pilot study on Brazil nuts will be performed on 3 or 4 of our staff. They will take 6 Brazil nuts daily (which will provide 48 micrograms Se/day) for 4 weeks. Their blood samples (on 2 occasions) will be collected at the baseline and after intervention. We believe this pilot study will provide important information as to how many Brazil nuts will be required per day to increase plasma Se levels, as we expand the research into an upcoming, full study. Background Information There is growing evidence that a combination of dietary agents may synergistically or additively improve the chemopreventive efficacy than any single dietary agent. Our previous studies in mouse CRC model have shown that Se activate apoptosis (Cancer Res. 2008 June 15;68(12):4938-44), whereas green tea up-regulates DNA repair enzyme. Our recent animal studies have further shown that combining Se and green tea is more effective in suppressing colorectal oncogenesis than either Se or green tea alone, and is associated with regulation of genetic and epigenetic biomarkers implicated in colonic carcinogenesis (submitted to Clinical Cancer Research). Se and green tea are particularly interesting as a combination not only because they can be co-administered in the diet but also because they have potentially complementary mechanisms of action. We now plan to expand our study to human subjects and determine if a combination dietary supplementation of Se and green tea provides greater health benefits than can be achieved from a single dietary agent of Se or green tea by regulating molecular biomarkers. We have used selenium-enriched milk protein as the Se source in our previous human trials (Br J Nutr 2011 Aug;106(4):572-82). It was our intention to continue using dairy Se product for our upcoming human trial. Unfortunately, the production and supply of selenium-enriched milk protein has been stopped by Tatura Milk Industries (VIC, Australia). We have to seek an alternative Se source from food, and have decided to use Brazil nuts because it is the richest known food source of Se. A previous randomized controlled human trial has shown that 2 Brazil nuts per day (provided 53micrograms Se/day) is as effective for increasing plasma Se status as 100 micrograms Seasselenomethionine during 12 weeks of intervention, reaching maximum plasma Se levels at 6 weeks (Am J ClinNutr 2008;87:379-3840). Se concentration in Brazil nuts (supplied from Charlesworth, Australia) has recently been analysed by National Measurement Institute (Australia Government, VIC), the average Se concentration in Brazil nuts is relatively low (2.7 micrograms Se/g) compared to that of the report by Thomson et al, where the Se concentration is 6.4 micrograms Se/g (Am J ClinNutr 2008;87:379-3840).

Cardiac resynchronization therapy pacemaker devices are now an established therapy for heart failure patients. However the optimal method to set up these devices is as yet uncertain. We aim to use echocardiography to optimize these devices on a patient specific basis. We will examine no optimization vs. resting optimization vs exercise optimization in a systematic manor to determine the superior method in terms of functional and cardiac improvment.

The aim of this clinical trial is to determine whether a novel starch (butyrylated high amylose maize starch, Starplus B) can protect against colorectal cancer. Butyrate is normally produced in the colon by the fermentation of dietary fibre, and Starplus B can increase the concentration of butyrate in the colon. Laboratory and animal experiments suggest butyrate from dietary Starplus B may reduce the risk of developing colon cancer. The study is a double blind, randomised controlled trial involving 120 volunteers likely to develop a genetic form of colon cancer (familial adenomatosis polyposis, FAP). FAP patients usually have most of their colon surgically removed by their early 20’s, and require regular follow-up colonoscopies to ensure they do not develop tumours in their residual rectum. After a baseline colonoscopy the FAP volunteers consume either Starplus B or placebo starch for 6 months, and then undergo a colonoscopy to assess the number and size of polyps and to sample the lining of the colon for analysis. The volunteers then consume the other starch for 6 months, and undergo a further colonoscopy. As the FAP gene mutation also occurs in the majority of sporadic (common) colorectal cancer, the study may identify a dietary chemo-preventative supplement which is likely to benefit the wider community who are at risk of developing sporadic colorectal cancer.

The CELSIUS Study is a prospective observational study of temperature measurement in critically ill patients with acute brain injury and sepsis in Australia and New Zealand. In these patients we are evaluating commonly used methods of temperature measurement (tympanic, axillary, nasopharyngeal) with assessment against a pragmatic gold standard of urinary bladder temperature (intravesical) measurement.