ANZCTR search results

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

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33127 results sorted by trial registration date.
  • The effect of plant and insect proteins on satiety

    High protein diets are effective at helping individuals maintain a healthy weight due to being highly satiating compared to other macronutrients. Supplementing protein into staple foods that are easily affordable, such as bread, is an easy way to incorporate added protein into a diet. However, it is difficult to recommend increasing protein intake at a population level because current farming practises that produce high-protein products from livestock are not sustainable, especially when considering climate change and increasing populations worldwide. Due to this, high-protein products made from livestock are becoming more expensive and less attainable. Proteins produced from sources other than livestock, such as plants and insects, are becoming more favourable as their production has a lower ecological footprint. However, the satiating effects of proteins are not necessarily equal, and it is unclear whether proteins from plants and insects are able to add a significant satiating effect when supplemented into staple foods. This study will assess the satiating effects plant and insect proteins within a staple food product compared to proteins derived from livestock. Participation in this study will involve attending four 30-minute morning sessions at the CASS Food Research Centre in Deakin University Burwood Campus. Before each session, participants will: • Need to fast for at least 10 hours (overnight). During each session, participants will: • Have their height and weight assessed (this will only occur during the first session). • Be provided with a moderate serving of bread which will be based on their estimated energy requirements which they will need to eat in its entirety. • Complete questionnaires about their liking of the bread and their appetite (approx. 2 minutes). After each session, participants will: • Complete additional appetite questionnaires every 30 minutes over the next 3 hours (approx. 2 minutes each). • Refrain from eating, drinking anything other than water, or doing any moderate to vigorous physical activity during this 3-hour period.

  • The effects of a vitamin and amino acid supplement on hangover symptom severity

    The aim of this study is to determine whether a natural product can improve hangover symptoms and several physiological changes that occur with hangover (i.e. liver function, inflammatory stress and stress hormone levels). A total of 44 participants aged 25-55 years old will complete this trial. The supplement contains a mix of vitamins and amino acid, which have been shown to improve the breakdown of alcohol-related toxins and/or improve hangover symptom severity. The combination of these ingredients has not been previously assessed in relation to hangover. Many biological changes occur with a hangover and contribute to hangover symptoms. We are particularly interested in the effects of hangover on liver function, inflammatory stress measured by cytokine levels, and stress according to cortisol levels. We will be measuring the effects of the supplement, compared to a placebo, using self-report assessments of hangover severity, anxiety, sleep quality and fatigue, cognitive functioning (e.g. response times, concentration, etc.) and physiological changes following an evening of alcohol intake to a quantity that would typically be consumed resulting in a hangover. We will also measure alcohol metabolism by asking participants to wear a wristband to measure alcohol in sweat, along with asking participants to undergo breathalyser and blood and urine tests for alcohol levels.. A subset of participants will be invited to participate in a brain imaging component using Magnetic Resonance Imaging (MRI).

  • Relationship between indocyanine green axillary reverse mapping related factors and lymphoedema in breast cancer

  • Investigating the effect of a smartphone-delivered wellbeing program on psychological stress.

    The aim of this study is to assess the effectives of a mindfulness-based and CBT-based mental health app on psychological stress in a sample of stressed (but otherwise healthy) individuals against an active control. The overall rationale for this study is to determine whether these apps can be used as a primary (prevention-focused) intervention for individuals who are are potentially at risk of developing a clinically significant psychological problem.

  • Physiotherapy Prehabilitation for cancer surgery patients.

    The purpose of this study is to determine whether a physiotherapist-led exercise prehabilitation program is effective in improving exercise tolerance, reducing hospital length of stay, and reducing post-operative complications in patients undergoing cancer surgery. Who is it for? You may be eligible for this study if you are aged 18 years or older, and are scheduled for complex surgery with a planned long anaesthetic time for upper gastrointestinal cancer, bowel cancer, or sarcoma. You will be included if you are receiving additional chemo radiation treatment or not. Study details All participants will receive a 6-week exercise program prior to surgery consisting of 2 sessions per week supervised by a physiotherapist. Sessions will be one hour in duration, and involve a walking program and resistance exercises using gymnasium equipment. The prescribed exercises will be tailored to each participant based on fitness levels assessed prior to the exercise program. Participants will complete a number of tests/questionnaires to assess exercise tolerance, frailty, strength, and quality of life before and after the 6-week exercise program, and will be monitored post-surgery until your hospital discharge date to record the length of stay in intensive care, time to mobilise out of bed, post-operative complications, and length of hospital stay. It is hoped that this study may demonstrate that an exercise prehabilitation program is effective at improving physical fitness and post-operative outcomes in patients undergoing complex cancer surgery.

  • The impact of hamstring holds or lengthening exercises on strength, muscle architecture and morphology.

    Hamstring strain injuries (HSI) represent the most common cause of time lost from competition within various running based sports. Persistent deficits in BFlh muscle volume has been found in athletes up to two years following HSI rehabilitation. Deficits in BFlh muscle volume likely impact on hamstring strength, which may contribute to persistent shortfalls in athletic performance seen after return to sport following HSI. In pennate muscles like the BFlh, most of the force produced during contraction is transmitted through the aponeurosis to the tendon and onto the bone. Theoretically, a stronger and bigger muscle would have a larger aponeurosis than smaller muscles to safely transmit the force produced during contractions. However, this isn’t the case in the BFlh. As such, understanding the adaptability of the aponeurosis is also important for HSI prevention and rehabilitation. Exercises that eccentrically load the hamstrings are effective at improving eccentric knee flexor strength, hamstring muscle volume and BFlh fascicle length, however the majority of interventions have focussed on knee-based exercises. There is potential that performing an eccentric only hip extension may lead to even greater adaptations, however, such an exercise has not been investigated nor has an isometric variation. The purpose of this study is to investigate the impact of an eccentric or isometric hip-extension exercise on hamstring strength, BFlh fascicle length, muscle volume and aponeurosis size. It is hypothesized that the eccentric training group will see greater improvements in strength, fascicle length, muscle volume and aponeurosis size than the isometric group following the intervention.

  • Does vitamin C decrease post-operative pain in surgery to the foot and ankle?

    We propose a randomised, controlled, feasibility study to determine the effectiveness of Vitamin C in the prevention of Complex Regional Pain Syndrome (CRPS) following lower limb surgery. This feasibility study will observe whether the proposed protocol is practical and replicable, and determine whether further study in this area needs to be adapted. We also expect to find a decrease in incidence of CRPS following administration of Vitamin C after surgery.

  • Cancer Molecular Screening and Therapeutics (MoST) Program Addendum 17 - substudies 38-39: Tepotinib

    This is a substudy of the Cancer Molecular Screening and Therapeutics (MoST) Program, which is registered on ANZCTR with ID ACTRN12616000908437. This substudy will evaluate the activity of tepotinib in a population of participants with metastatic non-small cell lung cancers (NSCLC) harbouring METex14 skipping mutations identified using comprehensive genomic profiling (CGP). Who is it for? You may be eligible to join the study if you are aged 18 years and older, with pathologically confirmed metastatic NSCLC. Your tumour will need to harbour METex14 skipping mutations identified using CGP. Study details: Participants will receive tepotinib treatment. The tepotinib is to be taken orally, at 500mg once daily (days 1 to 21 in a 21-day treatment cycle). Tepotinib will be given to participants continuously as long as they and their doctor agree there is a benefit from treatment. Participants will undergo imaging assessments at 6 weekly intervals from first treatment until 18 weeks, and then 12 weekly intervals until progression. Safety and tolerability of treatment will be assessed at 3 weekly intervals. Health related quality of life during treatment will be assessed at 3 weekly intervals and then every 9 weeks after end of treatment for 12 months, and then every 12 weeks until progression. We cannot guarantee that participants will receive any benefits from this study. This study is being carried out to improve the way we treat cancer patients who may have limited treatment options available to them. It is hoped that tepotinib will be well tolerated and will improve outcomes for future patients, however, there may be no clear benefit from participation in this study.

  • The effects of probiotics on bone loss/bone mineral density in early postemenopausal women

    Osteoporosis is a degenerative disease of the bone, which although occurs in older ages, has its roots in earlier life stages. Women are in general more susceptible to osteoporosis-related bone fractures than men, especially during the perimenopausal period, when the decrease in their oestrogen levels accelerates bone loss. Nevertheless, the increase of life expectancy in developed countries puts older men in a high risk of bone fractures too, especially after the age of 65 years. The adequate intake of certain nutrients that are essential for bone metabolism, such as calcium and vitamin D, plays an important role in maintaining bone mass. As such, supplementation with calcium and/or vitamin D has been reported to exert a significant favourable effect on bone metabolism and bone mineral density (BMD). Nevertheless, the low-grade inflammation induced by a shift in the balance of gut bacterial composition has been reported to impair the absorption of dietary calcium and other important nutrients, while at the same time it seems to stimulate bone resorption through an accelerated activity of osteoclasts. In this regard, it is now clear that the gut microbiome modulates bone haemostasis in mice, by regulating the immune system and osteoclast formation. The implication of this observation is that the modulation of the microbiome and/or inflammation may provide a new approach in the inhibition of age- and menopause-related bone loss and the prevention of osteoporosis. Aim: The aim of the proposed study is to examine the effect of a 12-month supplementation with a probiotic supplement that combines three strains of Lactobacillus on bone metabolism as well as on volumetric and areal BMD in Australian early postmenopausal females, aged 45-65 years, with an increased risk for osteoporosis.

  • An Open Label Extension on the Examination of the Combination of Dronabinol and Acetazolamide for Treatment of Obstructive Sleep Apnoea (OSA)

    Participants that have completed all study visits on Linked study: ACTRN 12620000916943, (Dose finding crossover trial investigating the effect of dronabinol combined with acetazolamide on Apnoea Hypopnea Index (AHI) in adults with obstructive sleep apnoea (OSA)) AND have an overall reduction in the Apnoea Hypopnoea Index (AHI) will be granted the option to participate in the IHLOSAOLE1 study. This will enable participants who had an overall reduction in OSA to continue to take the investigational product for a further 6 months (24 weeks). The participants will complete PSGs at the sleep clinic, Sleepiness, mood and quality of life questionnaires AHI, daytime somnolence, mood and quality of life scores will be compared to baseline to observe if efficacy is maintained over the 6 month period.

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