University of Copenhagen
Frederiksberg, 1958, Denmark
NCT Number: NCT05260762
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 microbiota composition in subjects who have overweight or obesity.
105 participants will be randomized in a 2:1 ratio to receive 15 g/day of AX or placebo.
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Notify Me20 year–65 year
All sexes
Interventional
Not applicable
Frederiksberg, 1958, Denmark
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 participants with a predominantly Bacteroides enterotype (inferred by a low Prevotella/Bacteroides-ratio). Specifically, we hypothesize that weight loss and P/B-ratio will be positively correlated in the AX supplementation-group whereas there will be no such correlation in the control-group. Consequently, we hypothesize that participants with the Bacteroides enterotype - and the lowest P/B-ratio - will have no benefit after AX supplementation while the weight loss effect of the AX supplementation will increase with increasing P/B-ratio.
Second, we hypothesize that the ability to digest starch in the upper gastrointestinal tract - evaluated by salivary alpha amylase gene (AMY1) copy number - will influence the interactions among AX intake, P/B ratio, and body weight change. Specifically, we hypothesize that there will be an association between body weight change and P/B ratio among subjects with a low AMY1 copy number, but not among the ones with a high AMY1 copy number, when consuming AX.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Dietary fiber product
Potato starch
Time frame: Baseline to week 12
Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg
Time frame: Baseline to week 12
Evaluated by use of Dual X-ray absorptiometry (DXA) scans
Time frame: Baseline to week 12
Changes in relative abundance of gut bacteria
Time frame: Baseline to week 12
Fasting plasma glucose (and insulin) concentrations
Time frame: Baseline to week 12
Indirect calorimetry with canopy mode
Time frame: Baseline to week 12
Systolic and diastolic blood pressure and pulse rate will be measured using a validated automatic device on the arm after 5-10 min rest in a resting position.
Time frame: Baseline to week 12
Total, LDL and HDL concentrations
Time frame: Baseline to week 12
ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK)
Time frame: Baseline to week 12
Assessment of fecal consistency by 3-day records
Time frame: Baseline to week 12
Assessment of dietary intake by 3-day dietary records
Time frame: Baseline to week 12
Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)]
Time frame: Baseline to week 12
Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)]
Time frame: Baseline to week 12
Thermographic camera
Time frame: Baseline to week 12
By bomb calorimeter
Time frame: Baseline to week 12
Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples
Time frame: Baseline to week 12
Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF
Time frame: Baseline to week 12
Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF
University of Copenhagen
Other
Personalized Obesity Management - Matching Dietary Fibers and Microbial Enterotype (POMFAME)
Acronym: POMFAME
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