ANZCTR search results

Whilst the importance of diet on health and well-being has long been established, there has been a recent interest in the effects of nutritional status on mood and memory. For instance, deficiencies in a number of nutrients have been associated with poorer mood. For this reason researchers have focused on the role of vitamins and minerals including folate, vitamins B12, B6 and zinc in the treatment of mood and stress disorders, as well as a way to improve cognition (i.e. memory, attention, mental function), general well-being and quality of life. Previous research studies have shown that taking a multivitamin for at least one month may improve the mood, general well-being and cognition of middle aged and older adults. This study will investigate the effects of a Women’s 50+ multivitamin supplement on mood, cognition and well-being.

Diabetes Mellitus is a global health concern and a national health priority area in Australia. In particular, type 2 diabetes mellitus (T2DM) is emerging as one of the greatest health threats in Australia, with approximately 90% of all individuals living with diabetes mellitus having T2DM. Being overweight or obese greatly increases the risk of progressing to T2DM (increasing the risk by four-fold). The link between obesity and progression to T2DM is attributed to changes in the immune system, specifically the inflammatory changes seen in individuals who are overweight or obese. Being inactive has also been shown to increase the risk of developing T2DM by two-fold. Although we know that the intensity of exercise can change the level of improvement seen in insulin sensitivity (higher intensity having greater effect), there is limited research investigating the role of high-intensity intermittent exercise (HIT) on insulin sensitivity. HIT uses alternating bouts of high-intensity and low-intensity exercise over the duration of the exercise bout and has recently demonstrated significant beneficial effects on health measures including body mass index (BMI). Therefore, the purpose of this study is to determine how insulin sensitivity and the immune system can be affected by exercise intensity. We hypothesise that the high-intensity intermittent exercise will be more effective in regulating glucose.

The primary objective of the current study is to replicate a recent study conducted in our centre (Benson et al., 2013) in order to confirm these results and to provide further data on the acute cognitive effects of an extract of Bacopa (KeenMind). The secondary objective of the study is to extend upon the study by Benson et al. (2013) by examining a wider range of doses to ascertain whether there is a dose-response relationship between KeenMind and cognition. The study will be an acute, 4-arm, randomised, double-blind, placebo-controlled crossover design. Participants will attend 4 testing sessions (and 1 practice session) where they will complete cognitive, mood and stress assessments, prior to and 1, 2 and 4 hours post supplementation. The participant group will be healthy adults aged between 18-55yrs, who are able to commit to five visits to Swinburne University to attend testing sessions. Participants will not be taking any supplements or medications and have no current medical or psychiatric diagnosis. Participants will orally consume each treatment one occasion, directly after a light meal. Each treatment will be administered after a 1 week wash out period. Treatment 1 – Placebo Treatment 2 – 320mg KeenMind Treatment 3 – 640mg KeenMind Treatment 4 – 960mg KeenMind

This study aims to test whether an internet-based workplace mental health induction program is effective in increasing mental health literacy, decreasing stigma and improving help-seeking attitudes and intentions for depression and anxiety when compared to a wait-list control group.

This study aims to test the efficacy of a decision-making tool, called a Decision Aid, for women with epilepsy who are in the process of deciding whether or not to have a child. It is hypothesised that women with epilepsy who receive the Decision Aid will report increased knowledge about pregnancy; reduced decisional conflict and increased decisional self-efficacy regarding their decision compared to women who do not receive the Decision Aid. In accordance with previous research, the Decision Aid is not expected to affect depression, anxiety or the direction of a woman's decision.

Malnutrition is a condition with negative implications affecting a substantial number of patients in healthcare facilities across Australia. It develops as a result of inadequate food intake, occurring due to factors associated with disease, illness and ageing and is often exacerbated by aspects of the hospital environment such as food provision. Preliminary data collected from subacute care inpatients (rehabilitation and Geriatric Evaluation and Management (GEM)) underpins this intervention trial. This research found that the 30% of patients were malnourished on admission and that overall, patients lost weight and muscle mass, demonstrating a decline in their nutritional status during inpatient stay. Additionally, less than 15% of patients consumed sufficient food or drink to provide 100% of their energy requirements and only half of all patients met 75% of their requirements. Well-nourished and malnourished patients alike experienced inadequate intake and nutritional decline. These data strongly suggest the need for more effective interventions to lower the risk of progression of malnutrition in healthcare facilities. Modifying or enhancing the nutritional value of food or drink or increasing the provision of items at meals and mid meals in hospital may be an approach that is more palatable and satisfying for patients and economically beneficial, compared to the provision of oral nutrition supplement drinks which are used widely in practice. There is some evidence from a handful of studies conducted across a range of healthcare settings that food based approaches result in greater dietary intake and patient centred outcomes, but there is a lack of evidence on clinical and functional benefits and cost. Additionally, previously high quality studies are lacking. The aim of this research is to implement a novel food service model to determine the effect of a nourishing menu compared to a usual menu on nutritional and clinical outcomes, patient satisfaction and cost among malnourished and well-nourished adult sub-acute care patients. This research will test the null hypotheses that there is no difference in weight change and cost of delivery between the intervention and the control. It is anticipated that the findings of this research, including data on cost of food service interventions, will have clinical relevance for the operation of the food service systems and dietetic practice.

To characterize the pharmacokinetics (PK) of three IPX233 formulations (C0001, C0002, T0001) compared with one IPX233 formulation (T0002).

This project will examine the effect of weight loss induced by the administration of the GLP-1 analogue, liraglutide, in combination with bariatric surgery or medical management on factors associated with metabolic and end-organ abnormalities. It is likely that liraglutide will improve the metabolic and neurohormonal profile of patients with obesity. Complications of obesity including cardiac pathology, neurocognitive dysfunction and sleep-disordered breathing may improve as a result of weight loss, with the use of a GLP-1 analogue.

Complications of ear disease, including hearing impairment and chronically infected ears, particularly chronic suppurative otitis media, can affect education, social circumstances and quality of life. Aboriginal and Torres Strait Islander children are known to have higher rates of otitis media than other children and to be more likely to develop complications. However, almost all of the research into prevalence, risk factors and treatment has been done in remote settings, despite the majority of Aboriginal and Torres Strait Islander peoples living in urban areas. In developed countries, immediate antibiotic treatment confers only a modestly decreased duration of pain and fever. Given the public health risks of antibiotic resistance, a “watchful waiting” approach to treatment is recommended for children at low risk of complications of AOM. Similarly, a recent change in national guidelines for treatment of AOM in Aboriginal and Torres Strait Islander children has recommended a shift from giving immediate antibiotic therapy for all such children, to using a “watchful waiting” approach in urban children presumed to be at low risk of complications. We will work with five Aboriginal Community Controlled Health Services and one Indigenous health service. With these services we will recruit approximately 500 children in order to provide randomised controlled trial (RCT) evidence to determine if watchful waiting is at least as effective as immediate antibiotic treatment for urban Aboriginal and Torres Strait Islander children with AOM. In addition, we will examine the cost effectiveness of the two treatment approaches from health services, societal and individual patient perspectives. We will also undertake qualitative research including process evaluation to document the implementation of the trial in each site, and the views and attitudes of the health care providers and study participants to the study and to the conduct of an RCT in Aboriginal and Torres Strait Islander communities. This is the first trial of antibiotics versus watchful waiting in urban Aboriginal and/or Torres Strait Islander children who present to a primary health care service with AOM. This research addresses two NHMRC priorities: Aboriginal health; and hearing. Our investigator team includes two Aboriginal researchers and staff from three Aboriginal health services who have contributed to this proposal from its early stages. Our research team is well placed to ensure translation of the research findings into policy and practice.

Colo-rectal cancer is increasing in the community and the most common site of spread is to the liver. Isolated liver deposits can be cured by surgery. For patients not fit or suitable for surgery other options need to be investigated. This clinical trial is investigating the use of stereotactic image guided radiotherapy for the treatment of colorectal liver metastases. Who is it for? This study will recruit participants that are aged 18 years or above and have up to 5 medically or surgically inoperable colorectal cancer liver metastases. Study details: All participants in this study will undergo stereotactic radiation therapy. This is a type of external radiation therapy that uses special equipment to more precisely deliver radiation to a tumour. Six radiotherapy sessions will be delivered over 2-3 weeks. Participants will be assessed for 3 years post treatment in order to evaluate treatment safety and disease response.