None listed
Conditions
Brief summary
The purpose of this study is to determine if it is possible to use a very low calorie diet in obese patients prior to surgery. Who is it for? You may be eligible for this study if you are an overweight adult who is undergoing surgery to remove all or part of your liver. Study details Participants in this study will be randomly selected to undergo one of the following: Group 1: participants in this group will be required to undergo a very low calorie diet for 2 weeks prior to their surgery, including 3 replacement meals per day. Group 2: participants in this group will continue with routine preoperative care with their physician. All participants will have will have an ultrasound elastography to measure Liver stiffness (steatosis) and liver size, and will have an ICG Clearance test to investigate liver function. It is hoped that this research will help determine if very low calorie diets can be completed by participants in the 2 weeks prior to their surgery, and whether the low calorie diet has any effect on surgery outcomes.
Interventions
Participants in the intervention group will be provided Optifast by their consulting physician and given a food diary. The two weeks’ worth of Optifast (Optifast milkshakes), which consists of three replacement meals (150 kcal per meal replacement) per day, will be given to the patient and they will be advised of the daily water requirements and other low calorie they should include to provide a total daily energy intake of approximately 800 kcal (3.3MJ).
Trial participants have a water require
Participants in the intervention group will be provided Optifast by their consulting physician and given a food diary. The two weeks’ worth of Optifast (Optifast milkshakes), which consists of three replacement meals (150 kcal per meal replacement) per day, will be given to the patient and they will be advised of the daily water requirements and other low calorie they should include to provide a total daily energy intake of approximately 800 kcal (3.3MJ). Trial participants have a water requirement of at least 2 litres of fluid including the VLED every day. This amounts to 8 cups of water, milk-free tea or coffee, low calorie soft drink, low calorie cordial every day. The only additional foods permitted include low calorie jelly, strained broth and certain vegetables. A teaspoon of vegetable or olive oil to the vegetable intake each day will be required to assist with gall bladder contraction in the absence of additional fat in the diet. The required water and the optional additional broth / vegetables will be provided by the participants. Participants will also complete a baseline QOL questionnaire
Sponsors
Sydney Local Health District
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
(i) Body Mass Index (BMI) >30 (obese); or a BMI >27 and a waist circumference in obese range (Caucasian – female >88cm, male >102cm; Asian/Aboriginal – female >30cm, male >90cm) (ii) Undergoing liver resection surgery (iii) Presenting to an Upper Gastrointestinal surgeon 2 week prior to surgery.
Exclusion criteria
(i) Clinically malnourished (ii) Pregnant or breastfeeding (iii) Have a comorbidity which prohibits restrictive dieting (in consultation with an endocrinologist), or a contra-indication to VLED (eg porphyria, recent myocardial infarction, unstable angina) (iv) Have a contraindication to (ICG) (iodine hypersensitivity, dialysis, renal failure) (v) Have cognitive impairment such as they cannot give consent, or (vi) Have inadequate English language skills to understand the intervention/ study.
Outcome results
None listed