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| Name | Class |
|---|---|
| General Mills | INDUSTRY |
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In recent years, the importance of the gut microbiota to human health has been demonstrated. In adulthood, the microbial profile is relatively stable, yet can be transiently altered by factors such as diet or antibiotic treatment. Such changes may be beneficial, as gut microbiota has been shown to differ in normal versus disease states including inflammatory bowel disease, obesity, type 2 diabetes and fatty liver disease. Given this relationship, there is intense interest in designing interventions that positively influence the gut microbial profile. Prebiotics are non-digestible, fermentable oligo- and polysaccharides that alter the colonic environment in favour of health-promoting bacterial species, such as bifidobacteria which selectively ferment prebiotics. Given the ability of prebiotics to beneficially alter the microbial profile, there is a need to identify the dosing requirements to positively modulate the gut microbiota. This study will test the effect of two doses of prebiotic on gut microbiota taxonomy and diversity.
The primary objective is to determine the effect of 4 week intake of a moderate dose (7 g/d) or low dose (2.5-3 g/d) of prebiotic on gut microbiota profiles in healthy adults compared to a non-prebiotic containing control.
The primary outcome is change in microbial composition (measured via 16S rRNA sequencing).
The secondary outcomes are change in gastrointestinal (GI) tolerance (measured via questionnaire); change in fecal short chain fatty acids; and change in quality of life.
This study will consist of two separate trials of 12 week duration. Each trial will be performed in a double-blind, randomized, placebo-controlled crossover manner with a 4 week intervention period followed by a 4 week wash-out period and final 4 week cross over.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control | Placebo Comparator | Isocaloric food without the test prebiotic. |
|
| Prebiotic | Experimental | Prebiotic consumed as one daily serving of 7 g in Group 1 and consumed as one daily serving of 2.5-3 g in Group 2. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control | Dietary Supplement | Isocaloric food without the test prebiotic. |
| |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline fecal bifidobacteria at 4 weeks | Assessed with 16S rRNA sequencing. | 4 weeks in cross-over design |
| Measure | Description | Time Frame |
|---|---|---|
| Change in baseline fecal short chain fatty acid concentrations at 4 weeks | Analyzed with gas chromatography/mass spectrophotometry | 4 weeks in cross-over design |
| Change in baseline gastrointestinal tolerance at 4 weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Raylene Reimer, PhD, RD | University of Calgary | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Calgary | Calgary | Alberta | T2N 1N4 | Canada |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32320024 | Derived | Reimer RA, Soto-Vaca A, Nicolucci AC, Mayengbam S, Park H, Madsen KL, Menon R, Vaughan EE. Effect of chicory inulin-type fructan-containing snack bars on the human gut microbiota in low dietary fiber consumers in a randomized crossover trial. Am J Clin Nutr. 2020 Jun 1;111(6):1286-1296. doi: 10.1093/ajcn/nqaa074. |
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| ID | Term |
|---|---|
| D056692 | Prebiotics |
| ID | Term |
|---|---|
| D004043 | Dietary Fiber |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D011135 | Polysaccharides, Bacterial |
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Crossover design with 4 week washout period.
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| Prebiotic |
| Dietary Supplement |
Prebiotic consumed as 7 g/d in a snack food in Group 1 and consumed as 2.5-3 g/d in a snack food in Group 2. |
|
Analyzed with questionnaire
| 4 weeks in cross-over design |
| Change in baseline quality of life rating at 4 weeks | Measured with SF-36 questionnaire | 4 weeks in cross-over design |
| D011134 |
| Polysaccharides |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019587 | Dietary Supplements |
| D019602 | Food and Beverages |