Clinical Trials being conducted at The Boden Institute
Currently recruiting participants
- EXSCEL Clinical Trial
- Exercise and liver fat reduction in pre-diabetes: moving beyond weight loss
- Effects of fast versus slow weight loss on fat, muscle & bone in post-menopausal women
- Are eggs good for people with type 2 diabetes?
- Cognitive behavioural therapy and electronic support for weight loss among obese patients: A randomised controlled trial
Fully recruited trials
- A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals
- The effectiveness of motivational enhancement therapy for obese patients and support partners in weight maintenance: A randomised controlled trial
- Gut Microbiota Trial
Type 2 diabetes is a leading public health issue. The majority of people with type 2 diabetes die as a result of cardiovascular disease (CVD). A number of trials in people with Type 2 diabetes have shown their CVD risk can be reduced by lowering cholesterol, blood pressure and glycated haemoglobin or all 3 risk factors.
The EXSCEL Trial is looking at a medication called Exenatide in reducing the above risk factors and promoting weight loss. Participants must have Type 2 diabetes and a history of cardiovascular disease. The medication is self injected once weekly and participants will be enrolled in the trial between 4-7 years. Appointments at the Institute will be twice a year. Participants will meet with our expert staff consisting of Endocrinologists, Nurses, Dietitians and Exercise Physiologists in managing their health care throughout the trial.
Contact: James Gerofi on 9036 3459 or
A fatty liver contributes to the risk of cardiovascular and metabolic disease (including diabetes) and is often seen in people who are overweight. Recent scientific studies have shown that exercise can lower liver fat with or without weight loss. However, there are currently no guidelines for exercise to manage liver fat levels.
This research aims to examine the components of regular exercise which result in a liver benefit by comparing different aerobic and resistance exercise programs on liver fat and cardiovascular risk outcomes. To be a participant in this trial you need to be aged between 29-59, have a body mass index (BMI) greater than 25 and not currently be undertaking regular exercise.
Now recruiting for a September intake.
Contact: Shelley Keating on 0405 735 200 or
For many years health professionals have recommended ‘slow and steady’ weight losses of approximately 0.1 to 1 kilo per week. In recent years however, an increasing number of health professionals are prescribing meal replacement diets called very low energy diets (VLEDs) because they can induce relatively fast weight losses of approximately 0.5 to 2 kilos per week, which some people find motivating, and because some people report not feeling hungry while following a VLED.
While VLEDs are known to be safe and effective in the short-term (for up to one year), the long-term consequences are unknown. This study will demonstrate whether or not there is any difference between the effects of weight loss via VLED or conventional diet on body fat content and distribution, muscle mass and strength, and bone density in post-menopausal women for 3 years after commencement of the diet.
Recruitment for this trial is currently underway. If you are female, living in the Sydney metropolitan area, aged 48-65, postmenopausal and you have a body mass index (BMI*) of 30 to 40 kg/m2, you may be eligible for this study.
*To calculate your BMI, divide your weight in kilograms by the square of your height in meters, or use this web-based BMI calculator: http://www.nhlbisupport.com/bmi/bmi-m.htm.
Contact: Dr Radhika Seimon on 9036 3445 / or Associate Professor Amanda Sainsbury-Salis on
You are invited to participate in a study investigating the role of eggs in the dietary management of type 2 diabetics. Eggs contain a number of important nutrients that may reduce the risk of cardiovascular disease including folate, long chain omega 3 fatty acids, and arginine. They have also been shown to improve our good cholesterol (high density lipoprotein-cholesterol – HDL-C). Improvements in HDL-C are known to reduce cardiovascular risk. Eggs are a nutrient-dense food that are not high in energy. Despite being rich in cholesterol, the amount of total fat and saturated fat in eggs is not high and the fat in eggs is predominantly unsaturated (44% monounsaturated; 11% polyunsaturated). The theoretical increase in cardiac risk from the cholesterol contained in eggs is likely to be minimal when compared to other cardiovascular risk factors including saturated fat intake, lack of physical activity, smoking, hypertension and obesity.
In this study we aim to identify the potential health benefits of a high egg diet in pre-diabetics and those with type 2 diabetes. Participants must be pre-diabetic or have type 2 diabetes, have a BMI greater than 25, and be able to follow a specific high egg diet (2 or more eggs/day for 6 days per week) or a low egg diet (less than 2 eggs per week). Participants are required to attend the Boden Institute for a total of 11 visits over 12 months, and will meet with our expert staff consisting of Endocrinologists, Nurses, Dietitians and Exercise Physiologists in managing their health care throughout the trial.
Contact: Nick Fuller on 9036 3468 or
Cognitive behavioural therapy and electronic support for weight loss among obese patients: A randomised controlled trial
As lifestyle decisions made continuously throughout each day determine an individual’s overall level of weight loss success, this study aims to assess the effectiveness of Cognitive Behavioural Therapy (CBT) combined with Electronic Support for improving weight loss among obese adults. CBT assists individuals to identify and overcome unhelpful thinking patterns that lead to problematic behaviours (such as emotional eating that results in excessive calorie intake and insufficient physical activity), thereby enabling them to make difficult long-term lifestyle changes that lead to sustained weight loss. In addition, novel modes of providing support to obese individuals are increasingly being adopted, with technology-based approaches (e.g., web-based treatment, e-mail contact etc) being used to improve participant engagement, monitor healthy behaviours, and maintain treatment gains.
The present study augments CBT treatment with daily electronic communication (in the form of daily text-messages and e-mail communication) so as to enhance the intensity of support provided to obese adults during the weight loss phase. The combined use of CBT and electronic support aims to provide individuals with the tools as well as the support required to successfully change their eating and physical activity patterns.
To be a participant in this trial you need to be aged between 18 and 65 years, have a body mass index (BMI) of 30 or above and not currently be undertaking any treatment for weight loss. Recruitment for this trial is currently underway.
Contact: Claire McAulay on 9036 3442 or if you are interested in participating.
** Please note: participants have now been fully recruited for this trial ** Regular exercise produces many health and fitness benefits, but the effectiveness of different types of exercise programs is unclear. Current health recommendations for people who are overweight suggest that exercise should be regular, low intensity and prolonged. However there is new evidence that exercise involving either short high intensity bursts of strenuous exercise with regular recovery periods, or stretching/massage and core stability work may produce these benefits in less time.
The aim of this research is to compare the benefits of different types of exercise programs. To be a participant in this trial you need to be aged between 18-55, have a body mass index (BMI) between 25 and 29.9 and not currently be undertaking regular exercise.
Contact: Shelley Keating on 0405 735 200 or
The effectiveness of motivational enhancement therapy for obese patients and support partners in weight maintenance: A randomised controlled trial
** Please note: participants have now been fully recruited for this trial ** The critical challenge for all obesity treatments is improving the maintenance of weight loss. As one of the most common barriers to successful weight management reported by individuals is “staying motivated”, this study aims to assess the effectiveness of Motivation Enhancement Therapy (MET) combined with a behavioural weight loss approach (BWL) for improving weight loss maintenance. MET aims to increase participant’s self-motivation to change problematic behaviours (such as excessive calorie intake and insufficient physical activity), thereby enabling them to make difficult long-term lifestyle changes that lead to sustained weight loss.
Combining MET and BWL treatment frameworks is designed to produce patients who are both highly motivated to change (MET) and have the tools to successfully change (BWL). The effectiveness of MET in this study will be augmented by instructing patient’s support partners in the practice of motivational enhancement strategies. Participants in this trial are between the ages of 18-70 years, have a body mass index (BMI) between 30-60 and are not currently undertaking any treatment for weight loss. Please note: recruitment for this trial has finished.
Contact: Clare Manns on 9036 3122 or
** Please note: participants have now been fully recruited for this trial ** This is a study of the role of microbiota in influencing the success of weight loss diets. Microbes influence how much energy we extract from our diet, how we regulate the storage of this as fat, and also on glucose regulation. There are both good and bad microbes. We have found that in overweight or obese persons undergoing weight loss diets, not everyone is successful and significantly those who fail to lose weight are also those who fail to change their microbial community composition.
In this study we aim to identify microbial signals in stool samples that will give successful weight loss outcomes and also to improve and change a person’s microbiota to a healthy composition. Participants must have a BMI between 25 and 35, be able to provide regular stool samples which will be collected in their home environment and brought in frozen for analysis of their gut microbiota, and follow a specific diet (high protein, low fat (low glycemic index), or a Mediterranean diet). Participants are required to attend the Boden Institute for a total of 10 visits over 12 months.
Contact: Nick Fuller on 9036 3468 or