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| Name | Class |
|---|---|
| Provident Clinical Research | OTHER |
| Tufts University | OTHER |
| University of Toronto | OTHER |
| University of Reading |
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The primary objective of this trial is to determine whether two doses of an extract from bran demonstrate a prebiotic effect on colonic bacteria (by modulating selected fecal microbial populations, particularly bifidobacteria). The secondary objective is to measure the potential beneficial effects of consuming an extract from bran on the following physiological parameters: laxation, fecal pH, fecal moisture and stool consistency, blood glucose and insulin concentrations, plasma lipid profiles and serum free fatty acids, colonic bacterial short chain fatty acid production, ammonia metabolism and protein degradation, and biomarkers of oxidative stress and inflammation.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control cereal | Placebo Comparator | grain-based ready to eat cereal that does not contain active wheat bran extract |
|
| low dose | Active Comparator | grain-based ready to eat cereal containing a low dose of wheat bran extract |
|
| High dose | Active Comparator | grain-based ready to eat cereal that contains a high dose of wheat bran extract |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| wheat bran extract | Other | Comparison of control cereal (containing no added wheat bran extract)to two test cereals containing different amounts of added wheat bran extract |
|
| Measure | Description | Time Frame |
|---|---|---|
| The primary outcome variable will be the difference between treatments in bifidobacteria counts per g of feces, expressed as log10 cells per g feces (dry weight) | Baseline to end of each treatment (week 0 to week 3 of each treatment) |
| Measure | Description | Time Frame |
|---|---|---|
| Other fecal bacterial counts | baseline to end of each treatment (week 0 to week 3 of each treatment) | |
| laxation | baseline to end of each treatment (week 0 to week 3 of each treatment) | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Kevin Maki, PhD | Provident Clinical Research and Consulting, Inc | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Provident CRC | Glen Ellyn | Illinois | 60137 | United States |
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| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
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| OTHER |
| University of Saskatchewan | OTHER |
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|
| control wheat bran extract | Other | Comparison of control cereal (containing no added wheat bran extract) to two test cereals containing different amounts of added wheat bran extract |
|
|
| fecal pH |
| baseline to end of each treatment (week 0 to week 3 of each treatment) |
| fecal moisture | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| stool consistency | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| blood glucose | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| Blood insulin | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| plasma lipid profiles | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| serum free fatty acids | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| fecal short chain fatty acids | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| fecal ammonia | baseline to end of each treament (week 0 to week 3 of each treatment) |
| urinary para-cresol | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| urinary phenol (total) | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| urinary isoprostanes | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| oxidized low density lipoprotein (TBARS, conjugated dienes) | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| Urinary F2alpha-isoprostanes | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| Plasma antioxidant capacity (ORAC, FRAP) | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| serum amyloid A | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| hs-CRP | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| IL-6 | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| TNF-alpha | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| gastrointestinal symptom survey | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| stool consistency (Bristol stool scale) | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| Quality of Life questionaire (Quality Metrics SF-36) | baseline to end of each treatment (week 0 to week 3 of each treatment) |
| D010829 |
| Physiological Phenomena |
| D019602 | Food and Beverages |