The effect of very-low energy diets for weight loss on gut microbiota composition and associated health in women with obesity: a randomised controlled trial

Barwon Health - University Hospital Geelong0 个研究点目标入组 47 人开始时间: 2020年3月5日最近更新: 2023年5月29日

适应症

试验速览

暂无简介。

•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

•> 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

发起方

Barwon Health - University Hospital Geelong