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| Name | Class |
|---|---|
| Personalized Lifestyle Medicine Center | UNKNOWN |
| National University of Natural Medicine | OTHER |
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This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.
Low microbial diversity in the intestine correlates with chronic diseases such as Inflammatory Bowel diseases, colorectal cancer, obesity, Type 1 and Type 2 diabetes and more. The incidence of chronic diseases is greater in the industrialized society consuming a diet low in microbiota-accessible-carbohydrates. Thus, research is growing to seek prebiotics, which are substrates that host microbes selectively use, providing a health benefit.
Better-tolerated prebiotics may be desirable, particularly for those avoiding FODMAPs (fermentable oligosaccharides, disaccharides, monosaccharides and polyols) due to gastrointestinal distress. Additionally, the intestinal microbiome may benefit from a diversity of prebiotics that may affect different types of bacteria to contribute to overall microbial diversity as well as provide stronger effects on positive outcomes. Resistant starch type 2, also called RS2, so named due to its ability to resist digestion in the upper gastrointestinal tract, is a candidate prebiotic, growing in popularity for increasing beneficial intestinal bacteria and improving gastrointestinal symptoms and reducing glycemic responses.
This study aims to test the hypothesis that a unique blend of resistant starches and fiber will promote gastrointestinal health, as measured by an increase in short-chain fatty acids and improvement in quality of life measures in conjunction with microbial community changes. This study specifically evaluates the impact on short-chain fatty acids and gut microbiota and the impact on quality of life from a resistant starch blend in healthy adult humans with occasional gastrointestinal distress.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| RS10-10-10 | Experimental | First 2 weeks is for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 10 g RS blend. Fourth 2 weeks is 10 g RS blend. |
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| RS10-20-20 | Experimental | First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 20 g RS blend. Fourth 2 weeks is 20 g RS blend. |
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| RS10-20-30 | Experimental | First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g resistant starch (RS) blend. Third 2 weeks is 20 g RS blend. Fourth 2 weeks is 30 g RS blend. |
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| Placebo10-10-10 | Placebo Comparator | First 2 weeks are for baseline variability measurement (no product). Second 2 weeks is 10 g placebo. Third 2 weeks is 10 g placebo. Fourth 2 weeks is 10 g placebo. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RS blend | Dietary Supplement | The intervention is a proprietary resistant starch blend. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Concentration of short-chain fatty acids from baseline to each product intervention | Concentration of total short-chain fatty acids, including valerate, isovalerate and isobutyrate, and individually-reported n-butyrate concentration as well as propionate and acetate % will be reported by Genova Diagnostics Report | Baseline (2 week period) compared to each product completion period of 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Change in fecal frequency (hours between stools) from baseline at each intervention | Fecal frequency (time in hours between stools) will be evaluated for each time period and compared between baseline (2 week period) and product intervention period (each 2 week period) | Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) |
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Exclusion criteria 4.1.1 Prohibited Medications, Supplements or Herbal Products Exclusionary
4.1.2 Medical History and Concurrent Diseases Exclusions
4.1.4 Other Exclusionary Criteria
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| Name | Affiliation | Role |
|---|---|---|
| Noelle Patno, PhD | Metagenics, Inc. | Principal Investigator |
| Joseph Lamb, MD | PLMC | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Personalized Lifestyle Medicine Center | Gig Harbor | Washington | 98332 | United States |
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Single-blind (subject)
| Placebo | Other | The placebo is starch. |
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| Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Diarrhea 6a) | Response pattern score on PROMIS Scale v1.0 - GI Diarrhea will be compared between baseline and each intervention period | Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) |
| Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Constipation) | Response pattern score on PROMIS Scale v1.0 - GI Constipation will be compared between baseline and each intervention period | Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) |
| Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016) | Response pattern score on PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016 will be compared between baseline and each intervention period | Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) |