ANZCTR search results

Protein-rich animal foods (cooked meat, dairy) are highly digestible - our bodies are able to utilise nearly all of the protein consumed, whereas the protein digestibility of plant based food products can vary considerably. Given the growing interest in alternative non-animal based sources of protein, it is important to establish the protein digestibility of these new foods and protein concentrates which has important health implications especially for vulnerable groups who have difficulty in consuming enough dietary protein. The gold standard method for measuring protein digestibility is the human ileostomy model, as it enables protein digestion to be quantified independent of protein degradation in the large intestine. The use of animal models involving rats and pigs has been preferred for determining the digestibility of dietary proteins over using people with an ileostomy due to the availability of study participants. However, to minimise the use of animals in research, a standardised in vitro method, INFOGEST, has been developed to simulate the digestion process. This method has undergone considerable validation which has included direct comparisons with protein digestibility measurements in humans. A majority of this validation work has focused on highly digestible animal meat and dairy products and the European COST INFOGEST consortium have identified the important need to further validate the model using non-animal based protein foods. Aim: To use the ileostomy model to determine the protein digestibility of three plant proteins and to validate an in vitro model of protein digestion (INFOGEST). Primary objective is to compare plant protein digestibility data obtained from the ileostomy model with that obtained from the INFOGEST model. Secondary Objective is to determine the protein digestibility of wheat-based food containing alternative plant-based high protein flours. Hypotheses: H0: That plant protein digestibility as measured by the INFOGEST method does not correlate with protein digestibility data obtained from the ileostomy model. H1: That plant protein digestibility as measured by the INFOGEST method correlates with protein digestibility data obtained from the ileostomy model

This trial evaluates the efficacy of two herbal medicines and a B-vitamin complex for improving stress and anxiety in adults who experienced elevated stress post-flooding natural disaster in the Northern Rivers Area of Australia. A total of 100 participants will be randomly allocated to one of four arms, and three out of these will receive the intervention for a total of 6 weeks each. The primary outcome is feasibility of study procedures and interventions. Perceived stress will be measured at the beginning and each 2 weeks until the end of the 6 weeks, and other mental health/quality of life measures will be included at baseline and 6 weeks.

This will be a Phase 1 first-in-human (FIH) study in 3 parts to evaluate the safety, tolerability, pharmacokinetics (PK), and pharmacodynamics (PD) of JNT-517 at various incremental doses administered as single and multiple doses in healthy volunteers. The study will begin with a single ascending dose portion (Part A) followed by the multiple ascending dose portion (Part B), and subsequently followed by high single ascending dose portion (Part F) in healthy volunteers in Australia to evaluate the safety, tolerability, PK, and PD of JNT-517 at various incremental doses.

Insomnia is a prevalent and debilitating disorder in Australia. The recommended treatment for insomnia is Cognitive Behavioural Therapy for insomnia (CBTi). However, there are very few clinicians in Australia with training in CBTi. Consequently, most patients with insomnia never access CBTi. Insomnia and sleep apnoea frequently co-occur. There is evidence that CBTi improves symptoms of insomnia, daytime function and quality of life in people with co-morbid insomnia and sleep apnoea. However, access to therapist-administered CBTi for people with co-morbid insomnia and sleep apnoea is very limited. Digital CBTi programs are an effective and potentially scalable intervention to manage insomnia in people with both insomnia and sleep apnoea. There are very few evidence-based digital CBTi programs available in Australia, and currently no publicly-available digital CBTi programs that provide personalised weekly behavioural therapy recommendations. This randomised controlled trial aims to investigate the effectiveness of a digital brief cognitive behavioural therpay for insomnia program, versus waitlist education control, on reducing insomnia symptoms in people with co-morbid insomnia and sleep apnoea. It is hyopthesised that the group who receive the brief CBTi program will report a greater reduction in insomnia symptoms, compared to the group that receive education (waitlist control).

Our First trial (ACTRN12615000898550) examined the immune responses to pertussis and other vaccine antigens following a modified infant vaccination schedule for DTPa-IPV-Hep B-Hib (Infanrix Hexa®) vaccine when given at 6 weeks, 12 weeks and 11-12 months of age. The immune responses in this study following this modified vaccine schedule will be compared to immune responses in a separate historical comparison study where Infanrix Hexa® vaccine was given at 6 weeks, 4 months, and 6 months of age), Continued study of the cohort enrolled onto ACTRN12615000898550 is a unique opportunity to examine the longer-term safety and immunogenicity at 18 to 36 months and again at 4 years old of children who followed the modified vaccine schedule and to compare their results with a historical cohort of infants who received pertussis-containing vaccines given according to the standard immunisation schedule. The key questions of prolonged immune tolerance to pertussis antigens, negative interference on concomitantly administered antigens and increased reactogenicity to booster doses following altered timing of Pa vaccination are only able to be answered by the long term follow up of our cohort. These are essential data to inform national vaccine policy and will be of considerable interest internationally. Antibody responses in the blood of children originally enrolled on ACTRN12615000898550, which are believed to correlate with protection, will be measured at (1) 18 to 36 months of age, at (2) 4 years of age pre-booster dose of DTPa-IPV vaccine and (3) 1 month after receipt of 4 year old DTPa-IPV booster vaccine. In addition, differences in immune and safety responses in the study cohort after receipt of the 4 year old booster dose of DTPa-IPV compared to historical controls who have received the existing vaccine schedule (at 6 weeks, 4 months and 6 months of age).

The proposed single-arm study will investigate the feasibility and utility of CLE and radial EBUS for the detection of lung parenchymal abnormalities in people with ILD. The study will establish the diagnostic yield of radial EBUS and CLE in detection of parenchymal abnormalities in patients with radiologic ILD, by comparing these techniques to the gold standard test of histology, as well as high-resolution CT chest imaging. Real-time assessment and recording of video imaging for later, de-identified review will also permit determination of intra-observer and inter-observer variability. Additional secondary outcomes include safety.

Some women have a caesarean section (abbreviated as CS) to have a baby. The safest anaesthetic for this is with an injection in the mother’s back to make her numb from her breasts down which is called epidural or spinal anaesthesia. CS can be categorised as elective (planned) or emergency (unplanned). Elective CS takes place before the onset of labour (uterine contraction), whereas most emergency CS occurs after labour has started. Hypothermia (a low body temperature) is a common problem during elective CS and consequently active warming is recommended. By contrast, hyperthermia (a high body temperature) is a side effect of epidural pain relief during labour and therefore it is possible that hyperthermia is the dominant problem during emergency CS. The temperature changes during emergency CS are not fully understood. It is important to study temperature changes during CS because hypothermia and hyperthermia can cause problems for her or the baby. Some mothers shiver during CS which is an unpleasant side effect that makes it difficult for mothers to hold their babies and breastfeed shortly after birth. What we know so far is shivering during elective CS is caused by hypothermia and is effectively treated with active warming. During emergency CS, however, shivering occurs at normal or increased body temperatures and therefore active warming is likely inappropriate. At present, body temperature is not routinely checked during CS and therefore it is not possible to tailor temperature regulation strategies to individuals’ needs. In this multicentre cohort study, we will investigate how patterns of body temperature change differ between elective and emergency CSs, and how this relates to shivering. We anticipate that this study will highlight the need to routinely measure body temperature during CS and will be a steppingstone towards personalised temperature management strategies during spinal and epidural anaesthesia.

Eggs provide an affordable, digestible and accessible source of many nutrients, including all eleven essential amino acids, vitamin A, E and B12, selenium, choline and iron, and unsaturated fatty acids including omega-3 (primarily DHA and ALA). Egg yolks are also high in cholesterol and are a major source of dietary cholesterol in Australia. There are current gaps in the research supporting egg intake and other associated health effects outside of plasma cholesterol levels, across different populations and age groups. Egg consumption microbiome studies in humans are extremely limited and have previously only focused on overweight postmenopausal women and/or effects on acute plasma choline levels and microbial taxa related to cardiovascular disease. The gut microbiome is thought to be a key component in Trimethylamine N-oxide (TMAO) metabolism, as trimethylamine is produced by gut bacteria from dietary choline, betaine, or L-carnitine, and then converted in the liver to TMAO, which in turn affects hepatic and intestinal lipid metabolism. Previous human studies have not shown egg consumption to affect plasma TMAO concentrations. However, inter-individual differences highlight the need for larger cohorts and more comprehensive assessment of the effects of egg consumption on gut microbiota. The overall aim is to examine the human gut microbiome in response to egg consumption (compared to no egg consumption) and explore other clinical outcomes (i.e., cognition) and potential mediating factors (i.e., inflammation regulation) in younger and older adults. Specifically, the aims are: 1. To assess effects of 6 weeks’ egg consumption on gut microbial composition and how consequent shifts in gut microbiome species and community function differ between age groups. 2. To explore how egg consumption may influence intuitive decision making, interoception, risk-taking and reaction-time 3. To explore how egg consumption may modulate intestinal immunity by altering levels of anti-inflammatory cytokines and other inflammatory markers such as C-reactive protein. 4. To explore the relationship between regular egg consumption, plasma choline, lipo-polysaccharide binding protein, and TMAO and how these levels may modulate or influence any of the above endpoints.

Patient outcomes following an ischaemic stroke are significantly improved by rescuing the ischaemic penumbra, the severely hypoperfused and hypoxic, electrically silent, at-risk brain tissue. ARG-007 offers the potential to reduce neuronal cell death and preserve still viable tissue in the penumbra in patients by disrupting the excitotoxic pathway that a stroke initiates, resulting in potentially enhanced functional recovery. This is a double-blind, randomized, placebo-controlled, study to assess the safety, tolerability, and pharmacokinetics of single ascending doses of ARG-007 in healthy participants at a single site in Australia. The primary objective of this study is to evaluate the safety and tolerability of single escalating doses of ARG-007 in healthy participants for 8 days, administered by intravenous infusion. The secondary objectives are to determine the pharmacokinetic profile and immune response profile of ARG-007 in healthy participants following single dose administration.

This project aims to improve the nutrition of Aboriginal infants. We will evaluate the effect of scheduled breastfeeding peer support for and by Aboriginal women, on breastfeeding initiation and prevalence of exclusive breastfeeding at six weeks, four months and six months post–birth. Our intervention will utilise both face-to-face peer support for and by Aboriginal women and employ innovative aspects such as social media, video & telephone calls by Aboriginal peer workers for a period of six months postnatally.