Status:
COMPLETED
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype
Lead Sponsor:
University of Copenhagen
Conditions:
Overweight and Obesity
Weight Loss
Eligibility:
All Genders
20-65 years
Phase:
NA
Brief Summary
The overall aim of this 12-week randomized controlled trial is to investigate if a dietary fiber supplement rich in arabinoxylans (AX) affects weight loss success differently according to baseline gut...
Detailed Description
First, we hypothesize that participants who have a predominantly Prevotella enterotype (inferred by a high Prevotella/Bacteroides-ratio) will lose more body weight after AX supplementation compared to...
Eligibility Criteria
Inclusion
- Apparently healthy men or women (self-reported nonpregnant, nonlactating, and not planning a pregnancy in the next 4 months)
- BMI: 25 to 40 kg/m2
- Non-smoker
- Want to maintain or lose weight
- Willing to consume wheat buns on a daily basis
Exclusion
- Consumption of whole grain products with every meal
- Use of antibiotics 60 days prior to the start of the study. If a participant uses antibiotics prior to randomization, they will be invited to be re-screened 3 months after the last use of antibiotics, provided that it is realistic to complete the study no later than the scheduled LPLV
- Dietary supplements with pro- and/or prebiotics 6 weeks prior to study
- Self-reported eating disorders
- Being a bodybuilder (\>4 strength training sessions per week)
- Alcohol intake above the recommendation from the Danish Health and Medicines Authority (\>21 units of alcohol per week)
- Night- or shift work
- Chronic diseases e.g. cancer within the past 5 years (except adequately-treated localized basal cell skin cancer), asthma, thyroid disease, cardiovascular disease, type 1 or 2 diabetes, inflammatory diseases, and celiac disease
- Disorders: neurological, sleep, diagnosed psychiatric disorder and gastrointestinal and liver disorders
- Surgical treatment of obesity and abdominal surgery
- Inability, physically or mental, to comply with the procedures required by the study protocol as evaluated by the daily study manager, principal investigator or clinical responsible
- Subject's general condition contraindicates continuing the study as evaluated by the daily study manager, principal investigator or clinical responsible
- Simultaneous blood donation for another purpose than this study
- Simultaneous participation in other clinical intervention studies
Key Trial Info
Start Date :
April 13 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 13 2023
Estimated Enrollment :
95 Patients enrolled
Trial Details
Trial ID
NCT05260762
Start Date
April 13 2022
End Date
June 13 2023
Last Update
June 22 2023
Active Locations (1)
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1
University of Copenhagen
Frederiksberg, Denmark, 1958