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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arabinoxylan | Active Comparator | Arabinoxylan (15 g AX/d) wheat buns |
|
| Control | Placebo Comparator | Non-fiber, carbohydrate control (15 g /d) wheat buns |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Arabinoxylan | Dietary Supplement | Dietary fiber product |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Body weight change | Weight will be measured using a calibrated digital scale,in kg to the nearest 0.1 kg | Baseline to week 12 |
| Measure | Description | Time Frame |
|---|---|---|
| Body fat change | Evaluated by use of Dual X-ray absorptiometry (DXA) scans | Baseline to week 12 |
| Fecal microbiota composition | Changes in relative abundance of gut bacteria |
| Measure | Description | Time Frame |
|---|---|---|
| Blood Pressure | 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. | Baseline to week 12 |
| Blood cholesterol concentration |
Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Copenhagen | Frederiksberg | 1958 | Denmark |
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| ID | Term |
|---|---|
| D050177 | Overweight |
| D009765 | Obesity |
| D015431 | Weight Loss |
| ID | Term |
|---|---|
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
| D001835 | Body Weight |
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| ID | Term |
|---|---|
| C085118 | arabinoxylan |
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| Control |
| Dietary Supplement |
Potato starch |
|
| Baseline to week 12 |
| Blood glucose metabolism | Fasting plasma glucose (and insulin) concentrations | Baseline to week 12 |
| Resting energy expenditure | Indirect calorimetry with canopy mode | Baseline to week 12 |
Total, LDL and HDL concentrations
| Baseline to week 12 |
| Appetite regulating hormones | ghrelin, glucagon-like peptide-1 (GLP-1), peptide YY (PYY), and cholecystokinin (CCK) | Baseline to week 12 |
| Fecal consistency | Assessment of fecal consistency by 3-day records | Baseline to week 12 |
| Energy and macronutrient intake | Assessment of dietary intake by 3-day dietary records | Baseline to week 12 |
| Subjective gastrointestinal (GI) symptoms | Assessment of subjective GI symptoms via visual analogue scales [1 (low) to 10 (high)] | Baseline to week 12 |
| Subjective appetite sensation | Assessment of subjective appetite sensation via visual analogue scales [1 (low) to 10 (high)] | Baseline to week 12 |
| Assessment of Brown Adipose Tissue (BAT) activity | Thermographic camera | Baseline to week 12 |
| Fecal energy concentration | By bomb calorimeter | Baseline to week 12 |
| Urine metabolome | Urine metabolome as determined by untargeted metabolic profiling by LC-QTOF of urine samples | Baseline to week 12 |
| Fecal metabolome | Fecal metabolome as determined by untargeted metabolic profiling by LC-QTOF | Baseline to week 12 |
| Plasma metabolome | Plasma metabolome as determined by untargeted metabolic profiling by LC-QTOF | Baseline to week 12 |
| D012816 |
| Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D001836 | Body Weight Changes |