ANZCTR search results

Objective: To determine whether 8-week administration of dietary prebiotic foods and/or probiotic supplements reduces symptoms of psychological distress in non-clinical adults with low mood and poor diet quality, relative to placebo. Secondary aims are to measure the relationship between treatment response and changes in cognition, well-being, health-related quality of life, sleep, and bowel health, and to determine whether treatment response is mediated by changes in gut microbiota. Hypotheses: It is hypothesised that both probiotic and prebiotic treatments will be superior to placebo, while the synbiotic treatment will potentially be superior to all others, in the reduction of psychological distress. It is also predicted that this pattern will remain consistent for measures of cognition, well-being, quality of life, bowel health and sleep. Finally, we hypothesise that treatment response will be mediated by changes in gut microbiota (showing lower levels of psychological distress versus higher levels of psychological distress in placebo). Design: An 8-week randomised controlled trial comparing the efficacy of a probiotic supplement versus a high-prebiotic diet versus a synbiotic treatment (probiotic + high-prebiotic diet) versus placebo in 128 healthy adults with poor mood and low dietary quality. The probiotic supplementation component will be double-blinded. Participants are community-dwelling adults aged 18-65 years who meet eligibility requirements for poor mood and low dietary quality.

Patients after cardiac surgery often develop a low blood pressure because of the inflammation associated with surgery and bypass. This low blood pressure is mostly due to the small blood vessels losing their normal tightness. This condition is called “vasoplegia”. When vasoplegia occurs after cardiac surgery, it can lower the blood pressure to dangerous levels, which can lead to organ malfunction and may even be life-threatening. In order to maintain safety under such a situation, intensive care doctors administer drugs that tighten blood vessels. These drugs are called vasopressors. Such vasopressors can restore safe levels of blood pressure. However, they have significant side effects. Thus, it would be desirable to restore a safe blood pressure without the use of such vasopressor drugs. Over the last few years, evidence has emerged that high dose vitamin C injected into the blood stream can restore the normal tightness of blood vessels and is free of side effects. This makes treatment with vitamin C potentially desirable in cardiac surgery patients with vasoplegia. However, no studies have assessed whether vitamin C at high dose is effective in this setting. Thus, we propose to conduct a pilot study to test whether vitamin C at high dose can improve blood pressure and decrease the need for vasopressor drugs in patients with vasoplegia after cardiac surgery.

The Body, Brain, Life Program for Mild Cognitive Impairment (BBL-MCI) is an online lifestyle modification program for people with Mild Cognitive Impairment (MCI) and subjective cognitive decline (SCD). MCI is a condition in which there are cognitive deficits in memory and other areas of thought, but these deficits are not sufficient to meet the criteria of a dementia diagnosis. SCD is condition where people are aware of and are concerned about minor cognitive deficits in day to day life, most often memory. People with MCI and SCD are at increased risk of dementia and there is some overlap in these groups, both are being included in this project. The aim of the study is to reduce dementia risk in these high risk groups and prevent further cognitive decline. The project will involve 4 online informational modules and 3 practical components. The online modules will be comprised of: A module on dementia literacy and risk factors; physical activity; diet and cognitive engagement. The practical components will enable participants to integrate physical activity, diet and cognitive engagement into their everyday lives. There are two research aims in this project: (i) Evaluate the effectiveness of BBL-MCI in the prevention of cognitive decline in individuals with MCI/SCD (ii) Evaluate the effectiveness of BBL-MCI to reduce overall risk for Alzheimer's disease and dementia as measured on the ANU-ADRI.

Shift workers face a 40% higher risk of heart disease and type-2 diabetes compared to day workers. Night shift workers are likely to change their sleeping and eating patterns to suit their work schedule. Therefore, the purpose of this study is to look at the effects of changing meal times at night on the heart health of shift workers. Briefly, the study involves two periods: 1) where participants are asked to avoid eating during a specified time period of the night and 2) where participants are asked to maintain their usual eating habits. We will then test to see the difference in participants’ blood fats, sugars, and other cardiovascular risk markers between these two periods.

This study will compare two brief interventions to see whether attention training or a mindfulness-based task is more efficacious in improving pain outcomes in healthy control participants.

In the majority of people with newly-diagnosed type 2 diabetes, the standard medical treatment starts with metformin, followed by the addition of other medications if blood glucose levels remain elevated. The purpose of this study is to evaluate the possible risks and the effectiveness of using three different tablets together to normalise blood glucose levels in adults with newly-diagnosed type 2 diabetes, compared with starting treatment with one tablet, and adding the other two tablets sequentially if blood glucose levels remain above normal. All of the tablets are already available for the treatment of type 2 diabetes, but the use of all 3 together in newly diagnosed diabetes has not been studied. Participants will be randomly assigned by a computer to receive treatment with metformin, saxagliptin and dapagliflozin together at the onset of the study, or to commence treatment with metformin, and add saxagliptin and dapagliflozin sequentially if their blood glucose levels remain above normal. Approximately 20 volunteers will be recruited to participate in the study. Participants’ involvement in the study will last 12 months, and include 5 study visits at the research site. Participants will have an initial medical assessment, and receive information about blood glucose self-monitoring, diet and lifestyle habits. They will then be randomly assigned to receive metformin 2000mg daily, saxagliptin 5mg daily and dapagliflozin 10mg daily either concurrently, or sequentially over 12 months. Participants will visit the research site every 4 months during the treatment period for monitoring. During these visits, participants will be weighed, have their blood pressure checked and blood glucose readings reviewed, and have a fasting blood and a urine test. At the beginning and end of the 12 month treatment period, participants will be also be asked to undergo testing of their blood glucose levels in response to a meal. Once all participants have completed the study, the study results will be analysed and released.

The aim of this study is to evaluate efficacy of a personalised pelvic floor muscle training program on urinary incontinence after radical prostatectomy. Who is it for? Individuals may be eligible to join this study if you aged 30-70 years and are scheduled to undergo radical prostatectomy (open or robotic) for prostate cancer. Study details Study participants will be allocated by chance to one of the three groups, Urethral muscle training, Conventional training or No training. Urethral muscle training will involve an individualised program of pelvic floor muscle training that relies on the principles of motor skill training of the striated muscles that control urethral pressure with ultrasound imaging used for assessment and biofeedback. Participants in both treatment groups will attend up to 10 sessions of pelvic floor muscle training supervised by a physiotherapist, and participants in the No treatment group will not receive treatment. Participants in the treatment groups will attend a session 1-2 weeks prior to surgery and will commence training before surgery. They will attend up to 9 sessions post-surgery, 1 week apart, commencing on catheter removal (~2 weeks post-surgery). This study will provide new insight into whether individualised pelvic floor muscle training is more effective than current treatments or no treatment for management of post-prostatectomy incontinence.

Both alone and in combination, the effects of Ketamine, Fentanyl and Dexmedetomidine are effective at providing analgesia to patients in the ICU. However, these drug combinations can potentially also have very important consequences for tasks involving complex cognitive and behavioural ability, which includes making important clinical decisions (in a clinical setting both during and post-treatment), and driving a car (post treatment discharge). Currently, it is unclear which clinically indicated drug combination (either KET/DEX or KET/FENT) has more favourable effects on sedation, alertness and cognitive/neurobehavioral outcomes. We therefore seek to test whether sub-anaesthetic KET/DEX combination will yield in better analgesic and alertness level when compared to KET/FENT, and if there are any differences in cognitive and neurobehavioral abilities between these drug conditions.

The aim of this research is to determine how effective real-time continuous glucose monitoring (RT-CGMS) compared with standard care self-management blood glucose (SMBG) is for improving glycaemic control, and enhancing quality of life in response to the prescription of a lifestyle modification program in overweight and obese individuals with type 2 diabetes (T2D) If shown to be effective, this innovative public health, clinical service delivery model can be used in a cost effective manner to enhance current self-management approaches for diabetes and be incorporated by health professionals as part of mainstream diabetes management practice that will improve cardiovascular health on a wide-scale community level.

Aim: To determine if hybrid exercise can improve fitness in persons with advanced MS. The primary outcome measures are the peak oxygen consumption achieved during the arm cranking and hybrid exercise trials. Secondary outcome measures will include the participant fatigue (Likert scale) and Fatigue Impact Scale, heart rate (Polar monitor) during arm cranking and hybrid exercise, Cardiopulmonary measures will be taken before exercise, during each workload, and after exercise. Intervention: Ten persons with advanced multiple sclerosis will undertake 12 weeks (2 days/weeks) of aerobic hybrid exercise training at the Faculty of Health Science, University of Sydney. Prior to commencement, 3 exercises tests will be conducted and repeated at the conclusion of the intervention. An incremental arm crank test will be conducted at the midpoint (6 weeks). The exercises tests include a maximum arm crank, incremental arm crank and hybrid FES cycling tests. Each test will be separated by between 2 days to a week. During the incremental arm crank and hybrid FES cycling test routine non-invasive measures of cardiorespiratory metabolism will be performed. Oxygen consumption and other cardiorespiratory metabolism will be measured by a metabolic cart. Heart rate will be monitored with a standard chest strap heart rate monitor. At the end of each exercise trial participants will be asked how hard the exercise felt and how fatigued they feel on a visual analogue scale. Training involves two sessions a week of hybrid FES cycling (total session duration including setup and debrief will be 60min). Arm cranking will be at 30:30 second intervals at 60% of maxPO and continuous FES cycling at maximum tolerable intensity (increased to this point over the first 20 minutes). During training perceived exertion will be taken every 5 minutes to ensure the participant is working at a rating of 14 (“somewhat hard”) on the 15-point BORG scale. Hypothesis: It is predicted the 12 weeks of hybrid FES cycling will be sufficient to illicit improvements in aerobic fitness. Therefore, the primary hypothesis tested is that hybrid FES exercise training will enhance the peak aerobic capacity elicited during arm crank exercise testing. Additional hypotheses will test other health related variables to determine if a program of Hybrid FES cycling has made any other impact on aerobic fitness and life in persons with advanced MS. The additional hypotheses are that: 1) Hybrid FES exercise training enhances the VO2Peak that can be produced during hybrid FES exercise testing and 2) Hybrid FES exercise training reduces the daily fatigue experienced (as measured by the fatigue impact scale [FIS]).