A pseudo-randomised dietary intervention to evaluate the effects of a high protein diet on weight loss, body composition and other health outcomes in obese individuals who have gastric banding surgery.
Completed
- Conditions
- ObesityDiet and Nutrition - Obesity
- Registration Number
- ACTRN12609000258257
- Lead Sponsor
- niversity of Newcastle
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 100
Inclusion Criteria
Undergoing or have undergone gastric banding no later than two weeks prior to study entry. - Body Mass Index (BMI) > 30 kg/m2. - Can understand, read and write English. - Has provided written, informed consent. - Surgeon has approved participation in the study
Exclusion Criteria
Chronic conditions requiring a specialised diet; food allergy or intolerance that may affect health or compliance with the study; vegetarian; individuals who cannot understand or follow the study diet; surgeon does not approve participation in the study; women who are pregnant or lactating; unwilling to be randomised to either diet group; pacemaker or other electronic implant.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Change in body composition (fat mass, fat free mass). <br>Body composition will be assessed using Dual x-ray absorptiometry (DXA) (Lunar Prodigy, GE Healthcare) in a subset of participants who meet the weight limitation criteria for the DXA equipment (134kg). All participants will also have body composition measured via bioimpedance analysis (BIA) using BIA scales (Tanita BF-310).[DXA will be undertaken at baseline, six and 12 months.<br>BIA will be undertaken at baseline, three, six and 12 months.];Change in body weight. Weight will be measured using digital scales correct to one decimal place (Tanita BF-310). Changes will be calculated as percentage difference from baseline.[Baseline, three, six and 12 months]
- Secondary Outcome Measures
Name Time Method Glucose metabolism (fasting insulin and glucose levels). This will be analysed from fasting blood samples. Homeostasis model assessment (HOMA) will be calculated from fasting glucose and insulin values as a surrogate index of insulin resistance.[Baseline, three, six and 12 months];Resting energy expenditure. This will be measured by indirect calorimetry using a ventilated hood system.[Baseline, six and 12 months.];Blood lipid profile [total cholesterol, low density lipoprotein (LDL) cholesterol, high density lipoprotein (HDL) cholesterol and triglycerides (TGs)]. This will be analysed from fasting blood samples.[Baseline, three, six and 12 months]