Dietary interventions for weight loss in women with obesity

Not Applicable

Completed

• Conditions: Gut microbiota; Obesity; Diet and Nutrition - Obesity; Oral and Gastrointestinal - Normal oral and gastrointestinal development and function; Metabolic and Endocrine - Normal metabolism and endocrine development and function

• Registration Number: ACTRN12620000301965
• Lead Sponsor: Barwon Health - University Hospital Geelong

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2020-03-05
• Study Completion: 2022-03-15
• Last Update Posted: 29 May 2023

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 47

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Gut microbiota composition (shotgun metagenomic analysis), with bacteria being the targeted organisms.[Baseline (week 0) and endpoint (week 3)]