Clinical Trials being conducted at The Boden Institute

Currently recruiting participants

Fully recruited trials


CURRENTLY RECRUITING

FBCx trial: Fibre supplement and Ginseng for weight loss and blood sugar control

James Gerofi and Mackenzie Fong from the Boden Institute

James Gerofi and Mackenzie Fong at the Boden Institute

Obesity is a serious chronic health issue that can result in debilitating health complications such as Type 2 diabetes mellitus. Identifying effective strategies to reduce the prevalence and severity of both is critical. The FBCx study will investigate two novel supplements, alpha cyclodextrin and Compound K.

Alpha cyclodextrin is a fibre supplement that has the ability to complex with and prevent the absorption of dietary fat more efficiently than other known dietary fibres. This supplement may assist with weight loss. Compound K is a Ginseng derivative that has been shown to have antidiabetic properties and therefore may help to assist with blood glucose control.

This is a 12 month trial involving a 6 month weight loss intervention followed by a 6 month weight maintenance phase. The key eligibility criteria are:

  • Males and females aged 18-70
  • BMI greater than 25*
  • Pre diabetes
  • Not taking any glucose lowering medication e.g. Metformin, Diamicron
  • Not taking any lipid lowering medication e.g. Lipitor, Crestor


*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.heartfoundation.org.au/healthy-eating/Pages/bmi-calculator.aspx.

Contact:
James Gerofi, Mackenzie Fong or Claire Madigan on 8627 0101 or

The TEMPO Diet Trial: Type of Energy Manipulation for Promoting optimum metabolic health and body composition in Obesity

DXA body scan

Participants receive a free 12 month weight loss program and regular body composition assessments to demonstrate their % of body fat, lean mass, and bone mineral density

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 calorie diets (VLCDs) 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 VLCD.

While VLCDs 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 VLCD or conventional diet on metabolic health, body fat content and distribution, muscle mass and strength, and bone density in post-menopausal women for 3 years after commencement of the diet.

To watch Associate Professor Amanda Salis talking about the TEMPO Diet Trial click here.

To watch Associate Professor Amanda Salis talking about A Day in the Life on a VLCD, click here.

To read the Information for Participants click here (PDF file).

Recruitment for the TEMPO Diet Trial is currently underway. If you are interested in participating in this trial and are female, living in the Sydney metropolitan area, aged 45-65, postmenopausal for 5 years or more, are non-diabetic 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.heartfoundation.org.au/healthy-eating/Pages/bmi-calculator.aspx.

Contact: The TEMPO Team (Ms Michelle Hsu, Dr Radhika Seimon, Ms Alice Gibson and Associate Professor Amanda Salis) on

For more information about Associate Professor Amanda Salis' research, please visit her Sydney Medical School research profile at http://sydney.edu.au/medicine/people/academics/profiles/asalis.php

A Novel Probiotic-based Intervention for Adults with Pre-diabetes and Recently Diagnosed with Type 2 Diabetes

Probiotics

Probiotics are live microorganisms which when administered in adequate amounts may confer health benefits to the host and may ameliorate obesity-associated dysbiosis by restoring the balance of the gastrointestinal microbiota and improving metabolic profiles. Probiotic-based intervention could be used to support standard lifestyle advice to control obesity-associated disorders.

We are conducting a clinical trial to investigate the therapeutic effect of a multi-strain probiotic in improving blood sugar levels and lipids and reducing inflammatory markers in obese men and women with known higher glucose levels. We are further examining whether the probiotic changes the gastrointestinal bacteria composition from a disease-prone to a balanced state. To qualify for participation you must be 18 years or older and have:

  • A BMI greater than or equal to 25 kg/m2
  • Pre-diabetes or being recently diagnosed with type 2 diabetes (within 12 months)

An oral glucose tolerance test will be performed to confirm if you are eligible. To be eligible you must stop taking (4 weeks before starting the trial) dietary supplements such as fish oils, herbal formulas, multivitamins, minerals, probiotics, prebiotics and antibiotics. People with serious disorders, including internal organ disease, inflammatory bowel disease, coeliac disease and also those diagnosed with diabetes for more than 12 months will be excluded.

Those who meet the criteria will be randomised to either the probiotic or placebo groups for 12 weeks duration. Four visits are required at the Boden Institute. Stool samples and blood samples will be required before supplementation and at week 12.

Contact: Talia Palacios on 02 8627 1962 / 04 5018 0801 /


FULLY RECRUITED

Exercise and liver fat reduction in pre-diabetes: moving beyond weight loss

** Please note: participants have now been fully recruited for this trial ** 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. Participants in this trial are aged between 29-59, have a body mass index (BMI) greater than 25 and are not currently undertaking regular exercise.

Contact: Shelley Keating on 0405 735 200 or

Arnott's Study: Vita-Weat supplementation on weight loss in an overweight and obese group

** Please note: participants have now been fully recruited for this trial ** Foods high in protein, slowly digested carbohydrate, and/or fibre are relatively more filling than equal-caloric portions of foods rich in fat or rapidly digested carbohydrate. This implies that those trying to lose weight should restrict their intake of less filling foods and should instead base their diet on relatively more filling foods, as a means of controlling their energy intake without needing a severe energy restriction.

The satiety index method was developed in order to rank equal energy portions of different foods by the extent to which they increased the feeling of fullness over a two-hour period. The most satisfying foods were found to be high in carbohydrate or protein, and most were also high in water and fibre. Considering the high carbohydrate (more than 60 grams per 100 grams) and high protein (more than 10 grams per 100 grams) content of the Arnott’s Vita-Weat range, these products may produce greater satiety and hence help produce weight loss for those needing to lose weight.

This study will investigate the degree to which different foods and nutrient formulations can maintain satiety (the feeling of fullness after a meal) in both normal weight and overweight people. If you need help to lose weight, you may be interested in participating in a randomised controlled trial of two different diets. For 6 weeks you will receive weight loss advice from our Dietitians and Exercise Physiologists (at no cost to you).

Participants in this trial are aged between 25 - 55 and have a body mass index (BMI) between 25 and 35 kg/m2. Participants with Type 1 diabetes, Type 2 diabetes on insulin or have celiac disease or gluten intolerance are not eligible. Female participants are pre-menopausal.

Contact: Mackenzie Fong on 8627 1931 or

HAPIFED Weight Management and Eating Disorder Program

** Please note: participants have now been fully recruited for this trial ** The Universities of Sydney and Western Sydney are conducting a free program for individuals 18 years or older who are overweight and who have a problem with binge eating or bulimia. The program aims to determine which of two treatments may be most effective at helping people to reduced disordered eating and at the same time improve weight management, so that they can lose weight and then maintain this weight loss over the longer-term. The program involves 19 skills-based group treatment sessions over 2 months.

Please contact:
Phone: 02 9351 5428
Email: or
For general enquiries please contact Dr Jessica Swinbourne on 02 8627 1929.

The PREVIEW Study Australia: Prevention of diabetes through lifestyle intervention

** Please note: participants have now been fully recruited for this trial ** Are you overweight? Do you lose weight but have trouble keeping it off?
If so, you could have ‘pre-diabetes’.

Professor Jennie Brand-Miller from the University of Sydney is looking for volunteers to take part in a free weight loss and weight maintenance program to help reduce the risk of developing type 2 diabetes.

This international study provides help from dietitians and your medical progress is fully monitored for 3 years. This is a new approach to weight control without the use of medications.

Call or SMS 0434 751 015
Or email:
Or visit http://www.preview.ning.com/sydney
For general enquiries please contact Ros Muirhead on 02 8627 1936.

EXSCEL Clinical Trial

** Please note: participants have now been fully recruited for this 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 are twice a year. Participants meet with our expert staff consisting of Endocrinologists, Nurses, Dietitians and Exercise Physiologists to manage their health care throughout the trial.

Contact: James Gerofi on 8627 1927 or

A novel exercise regime to reduce cardiometabolic risk in overweight sedentary individuals

** 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. Participants in this trial are aged between 18-55, have a body mass index (BMI) between 25 and 29.9 and are not currently undertaking regular exercise.

Contact: Shelley Keating on 0405 735 200 or