ANZCTR search results

These search results are from the Australian New Zealand Clinical Trials Registry (ANZCTR).

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31604 results sorted by trial registration date.
  • The effect of a short-term potato-enriched diet on muscle protein synthesis in recreationally active men

    The World Health Organization (WHO) recommends performing both strength/power (resistance-based exercise) and endurance activities (walking, running, cycling, swimming) for wellbeing. Appropriate nutritional support is essential to maximize the beneficial effects of any training program. In this regard, it is well accepted that the ingestion of high quality animal protein (meat and dairy products) as well as specially formulated high-protein bars and drinks have an additive effect in optimizing training-induced increases in muscle growth and strength following resistance-based exercise. In contrast, endurance-based training adaptations are amplified by the ingestion of carbohydrate-rich foods/supplements that rapidly restore muscle and liver glycogen stores and support skeletal muscle remodelling (i.e., mitochondrial biogenesis). Despite their benefits, current trends in consumer preferences driven by environmental factors, health benefits and/ or ethical reasons have brought to the forefront a need to advance knowledge of alternate food and beverage sources beyond conventional products. Vegan dietary practices are characterized by the avoidance of animal-based food ingredients, including dairy products and eggs. Such diets have been associated with a reduced risk of cardiovascular disease and type 2 diabetes. The proportion of individuals choosing to follow a vegan diet has increased in many industrialized nations and trend analysis predicts that their influence on the food sector will continue to grow. While numerous studies have investigated the postprandial muscle protein synthesis response to the ingestion of animal-based (dairy and meat) protein sources, little is known about the muscle protein synthesis response to plant-based proteins. To date, the anabolic properties of such plant-based proteins have only been investigated in limited protein sources. The primary aim of this project is to determine the effect of a non-animal protein diet on rates of muscle protein synthesis consumed during a short-term combined (‘concurrent’) resistance and endurance training program in healthy young males. It is hypothesized that a short-term, non-animal diet in combination with concurrent exercise will increase the synthesis and abundance of individual muscle proteins involved in the responses to both strength- and endurance-based exercise.

  • A pilot trial of a mental health app for Emergency Service Workers: the Build Back Better app

    Our research team has been funded by the Australian Government Department of Home Affairs to provide a suite of integrated mental health resources for individuals affected by the 2019/2020 bushfires (emergency service workers and their families), including an app-based prevention intervention tailored to the needs of this population. This pilot study aims to examine the feasibility of a smartphone application: Build Back Better; in providing evidence-based prevention strategies for anxiety, depression and PTSD for Emergency Service Workers and their adult family. The preliminary effectiveness for whether the intervention leads to any improvement in outcomes such as distress, wellbeing and common mental disorders will furthermore be explored. Participants will complete assessments at baseline and 1 month post- baseline. The smartphone application is intended to be used in a larger scale study aimed at promoting mental health and wellbeing within Emergency Service Workers and their families. The research questions/hypothesis that this study seeks to address are: 1. Explore the engagement with the components the app? 2. Explore the level of satisfaction with the app? 3. Explore the preferences of these individuals in terms of app content, format and design? 4. Explore the preliminary effectiveness in terms of improvements in wellbeing and symptom reduction? These include changes in alcohol and other drug use; self-reported recovery; health-related quality of life and mental health symptoms.

  • Peer Support as an Adjunct Treatment for Eating Disorder Patients Waitlisted for Clinical Treatment

    This study seeks to examine the feasibility and effectiveness of using peer support workers with lived experience of an eating disorder (ED) in the provision of treatment for EDs. While peer support and mentorship programs have been used in general mental health, there is little research to support their use in the field of EDs. However, there is some evidence to suggest that peer-led interventions might help overcome implementation barriers to clinician-led interventions and may increase feelings of hope and empowerment and decrease ED risk factors. For individuals waitlisted for treatment with the Statewide Eating Disorder Service, we hypothesize that peer support workers with lived experience of an ED offering 8 sessions of online guided self-help using the book “Eight Keys to Recovery from an Eating Disorder” will produce larger effect size decreases in eating disorder symptoms than guided self-help using a trainee health worker or wait-list alone.

  • The SerOzNET study seeks to better understand the safety and efficacy of the COVID-19 vaccines in people with cancer.

    This study will investigate the serological and immune response of cancer patients to the COVID-19 vaccine Who is it for? You may be eligible to join this study if you are aged 5 and above, have not received COVID-19 vaccination, with one or more of the following criteria: • Currently on chemotherapy • Currently on immunotherapy • Currently on hormonal therapy • Received chemotherapy 6-12 months ago • Have an allergy to either a vaccine or an anticancer treatment • Have a diagnosis of multiple myeloma, CLL, or low grade lymphoma, are eligible for government COVID-19 vaccination program and willing to receive the vaccine Study details All participants in this study will have serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting) at baseline, day 7 post initial vaccination, at booster appointment, 7 days post booster and at 3 months after booster vaccination. Administration of the vaccine itself and real-time collection/assessment/management of toxicities will not form part of the SerOzNET study. Patients will receive vaccination at their usual GP clinic or at one of the government vaccination centres, and then report adverse events and continue cancer care as per standard practice. It is hoped this research will contribute to the cancer immunology field in order to assist oncologist improve health outcomes for patients with cancer. The study involves serial sampling of blood and collection of data from “qualitative studies” (patient-reported adverse events, quality of life, common data elements (CDE), and vaccine hesitancy; together with post-hoc toxicity reporting).

  • Early Peanut Immunotherapy in Children (EPIC) - a trial of peanut oral immunotherapy to induce desensitisation in preschool aged children with a peanut allergy.

    The EPIC study is a randomised controlled trial (RCT) to establish the efficacy, safety and tolerability of a pragmatic peanut oral immunotherapy (OIT) protocol in children under 5 years of age in WA. We hypothesise that low dose peanut OIT in young preschool aged children will be effective and tolerable. Participants with peanut allergy will be randomised 1:1 to receive either peanut OIT or standard care (peanut avoidance) for 12 months. The OIT program consists of a daily dose of peanut flour incrementally increased under medical supervision every 2 weeks until a maintenance peanut protein dose of equivalent to approximately 1.5 peanuts is reached. After 12 months, all participants will have an oral food challenge (OFC) to establish their peanut eliciting dose, which will be defined as the amount of peanut they can consume before having an allergic reaction. We will compare the eliciting dose between participants receiving OIT and controls to determine the efficacy of peanut OIT. We will also collect and report quality of life and adverse event data to assess efficacy, safety and tolerability of this treatment. With this project, we are responding to an area of unmet need and consumer demand to provide access to food allergy treatments in Australia that are currently available overseas, using a translatable approach that could be applied to other foods and underpin a future national approach to food OIT.

  • Integrating the Choosing Wisely five questions into family meetings in the Intensive Care Unit: a randomised controlled trial.

    This study was approved as a quality improvement project by the Quality Improvement Head of Department at the North Metropolitan Area Health Service (GEKO #32792). This committee provided ethical approval for the investigators to consent and enrol participants into this interventional study. Summary of research project: Families presenting to the Intensive Care Unit (ICU) will be randomly allocated to either the control or intervention group. The intervention group will receive the Choosing Wisely five questions as pre-reading. The control group will not participate in any pre-reading. The family will then undergo a family meeting with the ICU doctor and nurse as planned. Post-family meeting the family member/s, doctor and nurse will complete a survey. The goal of this study is to investigate whether the pre-reading improves families' perceived involvement in decision making on behalf of their family member who is a patient in the ICU.

  • Cognitive Behaviour Therapy Versus Mindfulness for People with Rheumatoid Arthritis

    The current study aims to assess the efficacy of online CBT and MBSR interventions for people with Rheumatoid Arthritis and to see whether the effectiveness of these interventions is moderated by recurrent depression. It is expected that both CBT and MBSR will reduce pain interference, depression and anxiety relative to a waitlist control, but that MBSR will be more effective than CBT amongst those who also have recurrent depression.

  • A randomised controlled trial in cadavers investigating methods for intubation via a supraglottic airway device: comparison of fibre-optic-guided versus a modified retrograde technique performed by emergency physicians

    In this study we have chosen to compare two options for intubation via a supraglottic airway device (SGA). We feel this is a scenario likely to be encountered by emergency physicians as these devices are commonly used in this setting as a ‘rescue device’, which can temporarily allow ventilation when traditional laryngoscopy has failed to secure a definitive airway. The first method is a novel retrograde technique where the guidewire is passed via the SGA; this second method is a fibre-optic guided approach, also via the SGA. Our theory is that intubation via an SGA will allow an emergency physician to reliably achieve a secure airway as these devices are designed to open directly at the laryngeal inlet and so may be an ideal conduit for either retrograde or fibre-optic intubation of the trachea. The null hypothesis is that there is no difference in the time taken to secure an endotracheal tube by these two methods.

  • The effectiveness of a Mediterranean diet on hormonal, metabolic and body composition in overweight and obese women with Polycystic Ovary Syndrome.

    The purpose of this research project is to investigate the effectiveness of a Mediterranean diet on hormonal, metabolic, body weight and body composition without the need to reduce total calorie intake in overweight and obese women with diagnosed Polycystic Ovary Syndrome. This will be compared against a standard low-fat diet that is aligned with the Australian Dietary Guidelines. We are also interested in finding out participants' opinions on the Mediterranean diet and how well it can be followed. The Mediterranean diet is a type of dietary pattern high in vegetables, legumes, fruit, wholegrains and extra-virgin olive oil; moderate in nuts and seeds, fermented dairy, eggs, fish and seafood and red wine. We know that insulin resistance and risk for type 2 diabetes is a common metabolic consequence in reproductive-aged women with Polycystic Ovary Syndrome. In addition, many women with Polycystic Ovary Syndrome also have difficulty achieving a healthy weight, which further worsens insulin resistance. The current guidelines for the management of Polycystic Ovary Syndrome emphasise achieving and maintaining a healthy weight and lifestyle (diet and physical activity). However, there is no high-quality evidence supporting specific dietary recommendations for reproductive-aged women with Polycystic Ovary Syndrome. The Mediterranean diet is a type of dietary pattern consistent with good health and has shown to be effective at improving insulin resistance, even without the need to reduce total calories. Therefore, this study will provide a valuable contribution to the scientific knowledge in this field.

  • Investigating the ability of topical probiotics to change the bacterial profile of actinic keratosis from a detrimental to healthy composition

    Sun damaged skin can attract harmful bacteria that may secrete toxins that promote further damage and progression to skin cancer. This study aims to assess whether application of different skin creams including a probiotic and sunscreen has any effect on the type of bacteria that grow on sun damaged skin. Who is it for? You may be eligible for this study if you are aged 40 or older and you have known areas of sun damaged skin, which may or may not have lesions called 'actinic keratosis'. Please note that this study will *not* be enrolling patients with a diagnosis of skin cancer, melanoma or otherwise. Study details All participants who choose to enroll in this study will be randomly allocated by chance (similar to flipping a coin) to one of four different skin creams. You will be asked to apply your allocated skin cream directly to sun damaged skin on one side of your body, and nothing to the other side of your body for comparison. Application of the creams will occur 2x daily for 14 days. After 2 weeks of applying the creams, we will take samples (swabs) of your skin bacteria and determine the types of bacteria that have been growing. We will also take additional swabs at 3 weeks, 3 months and 6 months to determine any long terms changes in your skin bacteria. It is hoped this research will determine whether it is possible to change the bacteria that grow on your sun damaged skin to other (less harmful) bacteria that are found on normal skin. In the long term, this research might lead to a treatment for sun damaged skin, which may reduce the risk of skin cancer.

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