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Clinical Trials/ACTRN12620000301965
ACTRN12620000301965
Completed
未知

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 sites47 target enrollmentMarch 5, 2020

Overview

Phase
未知
Intervention
Not specified
Conditions
Gut microbiota
Sponsor
Barwon Health - University Hospital Geelong
Enrollment
47
Status
Completed
Last Updated
2 years ago

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
March 5, 2020
End Date
March 15, 2022
Last Updated
2 years ago
Study Type
Interventional
Sex
Female

Investigators

Sponsor
Barwon Health - University Hospital Geelong

Eligibility Criteria

Inclusion Criteria

  • 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

Outcomes

Primary Outcomes

Not specified

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