Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
The study will investigate the effect of cereal based prebiotic fibres on intestinal health and functioning and host metabolism.
A human dietary intervention study will be performed in overweight to obese subjects with a slow gastrointestinal transit time comparing the effects of a soluble prebiotic fibre vs. placebo on gut health, including gut microbiota composition, gastrointestinal transit time, metabolic health and quality of life.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Placebo | Placebo Comparator | 12 weeks placebo maltodextrin 15g/day ( 5 g in beverage, to be consumed three times a day) |
|
| soluble wheat bran fibre | Experimental | 12 weeks soluble wheat bran fibre 15g/day (5 g in beverage, to be consumed three times a day) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| soluble wheat bran fibre | Dietary Supplement | 12 weeks daily intake of 15g of soluble wheat bran fibre |
|
| Measure | Description | Time Frame |
|---|---|---|
| Whole gut transit time [hours] | Whole gut transit time as measured by radio-opaque marker method | measured at baseline at week 1 and directly after the 12 week supplementation |
| Measure | Description | Time Frame |
|---|---|---|
| Gastric emptying [min] | Gastric emptying measured by isotope breath test | measured at baseline at week 1 and directly after the 12 week supplementation |
| Oro-cecal transit time [min] | Oro-cecal transit time measured by hydrogen breath test |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Woman lactating, pregnant (where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by a positive hCG laboratory test) or (post)-menopausal
Regular smokers
People with intensive fitness training, eg. athletes (≥3 per week ≥ 1 hour training)
Diabetes Mellitus (defined as FPG ≥ 7.0 mmol/l and or 2h PG ≥ 11.1 mmol/l)
Gastro-intestinal diseases or abdominal surgery, cardiovascular diseases, cancer, liver or kidney malfunctioning (determined based on ALAT and creatinine levels, respectively) disease with a life expectation shorter than 5 years
Following a hypocaloric diet
Gluten intolerance
Regular use of laxation products, or use of antibiotics, probiotics or prebiotics 3 months prior to the start of the study
More than 2 symptoms occurring over a period of 12 weeks in the preceding 12 months such as
Current use of medication interfering with study intervention or interfering with study endpoints/hypotheses
Not to be able to understand the study information
Blood donation 2 months prior to the study and during the study
Participation in other studies
Not provided
Not provided
Not provided
Not provided
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 31983281 | Derived | Muller M, Hermes GDA, Emanuel E C, Holst JJ, Zoetendal EG, Smidt H, Troost F, Schaap FG, Damink SO, Jocken JWE, Lenaerts K, Masclee AAM, Blaak EE. Effect of wheat bran derived prebiotic supplementation on gastrointestinal transit, gut microbiota, and metabolic health: a randomized controlled trial in healthy adults with a slow gut transit. Gut Microbes. 2020 Nov 9;12(1):1704141. doi: 10.1080/19490976.2019.1704141. Epub 2020 Jan 25. |
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| C008315 | maltodextrin |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Placebo | Dietary Supplement | 12 weeks daily intake of 15g of maltodextrin |
|
|
| measured at baseline at week 1 and directly after the 12 week supplementation |
| Defecation frequency (bowel movement per day) | Defecation frequency as measured via questionnaire | measured at baseline at week 1 and directly after the 12 week supplementation |
| Energy expenditure | Energy expenditure measured by indirect calorimetry | measured at baseline at week 1 and directly after the 12 week supplementation |
| Substrate oxidation | Fat and carbohydrate oxidation measured by indirect calorimetry | measured at baseline at week 1 and directly after the 12 week supplementation |
| Plasma inflammatory cytokines Interleukin-6,8 and 1 (pg/ml) | IL-6, IL8,IL-1 measured by enzyme linked immunosorbent assay | measured at baseline at week 1 and directly after the 12 week supplementation |
| Adipose tissue gene expression | Adipose tissue gene expression measured by quantitative real time polymerase chain reaction | measured at baseline at week 1 and directly after the 12 week supplementation |
| Gut permeability | Gut permeability as measured by multi sugar assay | measured at baseline at week 1 and directly after the 12 week supplementation |
| Microbiota composition | Microbiota composition as measured by illumina sequencing in feces | measured at baseline at week 1 and directly after the 12 week supplementation |
| Fecal Short chain fatty acid concentrations | Fecal Short chain fatty acid concentrations measured by ion exchange chromatography with conductivity detection | measured at baseline at week 1 and directly after the 12 week supplementation |
| Plasma short chain fatty acid concentrations | Plasma short chain fatty acid concentrations measured by liquid chromatography-mass spectrometry | measured at baseline at week 1 and directly after the 12 week supplementation |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |