None listed
Conditions
Brief summary
Obesity is one of the most prevalent and challenging diseases affecting our community. According to the latest census figures, 63.4% of Australians aged 18 years and over were overweight or obese, namely, 35.0% overweight and 28.3% obese. Along with the increase in our community BMI has been a burgeoning of obesity related diseases including type II diabetes, cardiovascular disease, osteoarthritis, hypertension, liver disease, depression and infertility. Weight loss leads to a significant improvement in these conditions. Currently the only durably effective treatment for the most severe grades of obesity is bariatric surgery. Conservative programs are effective in the short-term, however, only 3% of successful weight losers are able to maintain a meaningful weight loss beyond 2 years. Pre-operative weight loss with a short term very low calorie diet (VLCD) has been shown to improve surgical access by reducing liver volume as well as the metabolic status of the patient, reducing the number of postoperative complications. For this reason, most clinicians request their patients to undertake a preoperative weight loss programme for a minimum of two weeks. Whilst clinicians perceive a benefit for preoperative weight loss, patients often struggle to comply. One reason for this is the difficulty complying with the currently available VLCD. Most are based on liquid formulations and patients struggle with the taste and texture of the product. Patients regularly report bloating, abdominal discomfort and constipation. In addition, the nutritional construct is often based around a large amount of sugar, and lacks high quality protein and fibre. Formulite (Trademark) is a new VLCD that the manufacturers claim retains the benefit of traditional VLCD, inducing Ketosis thereby avoiding hunger, whist reducing the unwanted GI side effects by combining high quality proteins with soluble fibre, less sugar and probiotics. These changes are supposed to improve patient compliance. We wish to confirm potential benefits of Formulite in patients undergoing bariatric surgery. We hypothesised that patient satisfaction would be higher and therefore compliance with the preoperative weight loss programme would be improved when compared with traditional VLCD. HYPOTHESIS: Compliance with Formulite is better than traditional VLCD prior to bariatric surgery in obese adults. AIMS: - To measure patient compliance with Formulite compared to traditional VLCD - To determine if there are improved gastrointestinal symptoms with Formulite compared to traditional VLCD - To assess patient satisfaction with Formulite compared to traditional VLCD - TO measure peri-operative liver volume and weight loss following 2 weeks of Formulite when compared to traditional VLCD
Interventions
This randomised controlled trial will compare the traditional very low calorie diet (VLCD) (Optifast) with a new formulation (Formulite). This aims to assess compliance and GI symptoms prior to bariatric surgery.
The usual regime for VLCD (e.g. Optifast, Formulite or other) prior to bariatric surgery involves:
- 3 meal complete replacement with 3 satchets of VLCD (mixed with water to form a milkshake)
- plain steamed green or leafy vegetables (as much or as little)
- black coffee or tea if des
This randomised controlled trial will compare the traditional very low calorie diet (VLCD) (Optifast) with a new formulation (Formulite). This aims to assess compliance and GI symptoms prior to bariatric surgery. The usual regime for VLCD (e.g. Optifast, Formulite or other) prior to bariatric surgery involves: - 3 meal complete replacement with 3 satchets of VLCD (mixed with water to form a milkshake) - plain steamed green or leafy vegetables (as much or as little) - black coffee or tea if desired (as much or as little) - Water as desired - No other foods or drinks For this study, patients will follow this usual regime for the Formulite arm and Optifast arm. Energy per 55g serve = 858kj The VLCD regime is used for 2 weeks prior to surgery. The main purpose of the regime is to reduce liver size, aiding in the ease and feasibility of the operation which requires access to the upper stomach. This can be obscured if the liver is large, as is the case in obesity. Adherence to the regime will be monitored by packets of VLCD remaining, as well as urinary ketones measured weekly during the trial.
Sponsors
Centre for Obesity Research and Education, Monash University
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
Obese adult participants undergoing bariatric surgery
Exclusion criteria
Unfit for bariatric surgery
Outcome results
None listed