None listed
Conditions
Brief summary
The primary aim of this study is to investigate the possible differential effects of two VLEDs on gut microbiota composition and associated health in women with obesity. It is hypothesised that from baseline to endpoint, those allocated to the food-based VLED will have more diverse and abundant bacterial microbes compared to those in the supplement-based VLED. It is also hypothesised that those allocated to the food-based VLED will have more beneficial metabolic and mental health outcomes relative to the supplement-based VLED.
Interventions
The proposed study is a 3-week; 1:1 parallel-group, randomised, controlled trial of a food-based compared to a supplement based very-low energy diet (VLED) for weight loss in women with obesity. Participants will be randomly assigned to receive either a food-based VLED (diet A) or supplement-based VLED (diet B) using block randomisation.
Food-based VLED consumables:
All breakfast, lunch, dinner and a protein snack (1 per day) will be provided as part of the Rapid Weight Loss Program outlined by
The proposed study is a 3-week; 1:1 parallel-group, randomised, controlled trial of a food-based compared to a supplement based very-low energy diet (VLED) for weight loss in women with obesity. Participants will be randomly assigned to receive either a food-based VLED (diet A) or supplement-based VLED (diet B) using block randomisation. Food-based VLED consumables: All breakfast, lunch, dinner and a protein snack (1 per day) will be provided as part of the Rapid Weight Loss Program outlined by Be Fit Food (vegetarian, gluten free and meat-based programs provided). As part of the Rapid Weight Loss Program, participants’ food plan will contain 820-920kcal per day (3347-3766kJ) with meal replacements containing no added sugar, low sodium and carbohydrate, high protein, and various vegetables per serve. In addition to meals, participants will be recommended to consume food from a ‘Recommended Extras’ list (Appendix 1, food-based condition). Food on this list includes low carbohydrate side vegetables and salads that participants can prepare themselves to have alongside the Be Fit Food meal replacements. The meals replacements are calorie controlled and consist of levels of protein, fatty acids, carbohydrates, vitamins and minerals suggested for effective weight loss. The food-based VLED consumables are designed by Accredited Practicing Dietitians. These ready-made home delivered meals are created and prepared by qualified chefs. In addition, at study Visit 1, participants will receive dietary recommendations designed by an Accredited Practicing Dietitian to aid with adherence to the intervention. Although it is recognised that the provision of food, particularly ready-made meals, help to ensure dietary adherence due to their convenience as well as promoting a more tightly controlled dietary intervention than if participants were preparing meals themselves, the MicroFit Study aims to assess adherence to the dietary prescription through the utilisation of the Easy Diet Diary app. The Easy Diet Diary is a free app available on smart phones and contains a database of commonly eaten foods for users to add to a diary at each eating occasion, without providing feedback about nutrition content. Dietary intake data from the app will be available to the researchers online and will be analysed for the energy and nutrient composition using FoodWorks (Xyris Software Pty Ltd, Australia).
Sponsors
Barwon Health - University Hospital Geelong
Study design
Allocation
Randomised controlled trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
30 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
• Female • Aged between 30-65 years (at baseline) • BMI between 30 kg.m-2 and 45 kg.m-2 • Willingness to commit to consuming only pre-made, pre-packaged food-based or supplement-based dietary products (in conjunction with Recommended Extras food) provided by the study for duration of study • Available for study duration • Ability to understand study directions and materials in English • Access to internet and computer, smart phone or tablet • Willingness to comply with all requirements and procedures of the study • Agree not to enrol in another intervention clinical research trial while part of the study
Exclusion criteria
• > 65 years and < 30 years • BMI > 45 kg.m-2 • Current consumer of VLED weight loss consumables • Food allergies (established medical diagnosis) • Pregnant, planning to become pregnant during the trial period, or lactating • Diagnosed with or commenced new treatment for, anxiety and/or depression, within 1 month prior to baseline • Gastrointestinal (GI) diseases or past major GI surgery likely to interfere with study outcomes • Type Two Diabetes Mellitus • Porphyria • Recent heart attack within the past six months • Heart disease / failure or unstable angina • Severe or advanced kidney / liver disease • Any other condition the research team deem the prospective participant unfit to participate in the study • Eating disorder(s) (established diagnosis) • Other major medical conditions likely to have major systemic effects • Regular use of the following: • morphine/opioid-based medications • recreational/illicit drugs • Sodium-glucose co-transporter-2 (SGLT2) inhibitors (“gliflozins”) • Antibiotic, prebiotic and/or probiotic use within 1 month prior to baseline • Enrolment in another clinical trial within the past 3 months
Outcome results
None listed