Status:
COMPLETED
The Impact of a Powdered Meal Replacement on Metabolism and Gut Microbiota
Lead Sponsor:
University of Alberta
Collaborating Sponsors:
Almased Wellness GmbH
Conditions:
Dietary Modification
Eligibility:
All Genders
18-50 years
Phase:
NA
Brief Summary
This study will investigate the impact of a 12-week powdered meal replacement on inflammatory, metabolic, and hormonal markers of obesity-associated conditions and to correlate this response to compos...
Detailed Description
Overweight and obesity increase the risk of developing several diseases having a negative effect on people's health. The prevalence of these conditions is increasing worldwide, but successful treatmen...
Eligibility Criteria
Inclusion
- Non-smoker;
- Female/Male;
- Aged 18 to 50 years;
- Body mass index (BMI) between 25 and 37 kg/m²;
- Weight stable (\< ± 5 kg over past 6 months);
- Fat mass ≥20% for men and ≥25% for women;
- Maintaining current levels of physical activity throughout the study.
- Female participants must verify use of acceptable, effective birth control methods (total abstinence, hormonal birth control \[oral, injectable, transdermal, intravaginal\], intrauterine devices, confirmed successful vasectomy or partner, or condoms).
Exclusion
- Diagnosis of chronic diseases or acute infections;
- Taking any medication that may alter inflammation, energy metabolism, body weight and composition, gut microbiota and hormone levels; investigators should always be informed if there are any changes in medications or Natural health product use;
- Taking pre- and probiotics (e.g. supplements);
- Use of antibiotics in the past two months;
- Use of thyroid replacement therapy;
- Use of nutritional supplements in the past four weeks (multivitamin and vitamin D3 are permitted to be used during the course of the study);
- Allergy to any ingredient (including non-medicinal ingredients) in investigational product;
- Lactose, gluten and/or soy allergic/intolerant;
- Follow a vegetarian, vegan or any restrictive dietary pattern;
- Pregnant or lactating;
- Perform over three hours of vigorous physical activity per week;
- A nuclear medicine scan or injection of an X-ray dye in the past week;
- A barium test/exam in the last two weeks;
- Suffer from claustrophobia;
- Inability to comprehend and complete the required questionnaires.
Key Trial Info
Start Date :
April 1 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 8 2023
Estimated Enrollment :
88 Patients enrolled
Trial Details
Trial ID
NCT03235804
Start Date
April 1 2019
End Date
December 8 2023
Last Update
December 14 2023
Active Locations (1)
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1
Human Nutrition Research Unit
Edmonton, Alberta, Canada