Resistant Starch Blend Gastrointestinal Impact
- Conditions
- Quality of LifeHealth, Subjective
- Interventions
- Dietary Supplement: RS blendOther: Placebo
- Registration Number
- NCT03983772
- Lead Sponsor
- Metagenics, Inc.
- Brief Summary
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.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 43
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description RS10-10-10 RS blend 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. RS10-20-30 RS blend 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. Placebo10-10-10 Placebo 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. RS10-20-20 RS blend 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.
- Primary Outcome Measures
Name Time Method Change in Concentration of short-chain fatty acids from baseline to each product intervention Baseline (2 week period) compared to each product completion period of 2 weeks 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
- Secondary Outcome Measures
Name Time Method Change in fecal frequency (hours between stools) from baseline at each intervention Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) 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)
Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Gas and Bloating 13a 09-02-2016) Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) 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
Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Diarrhea 6a) Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) Response pattern score on PROMIS Scale v1.0 - GI Diarrhea will be compared between baseline and each intervention period
Change in Response pattern score for Frequency and Severity of Gastrointestinal Symptoms (PROMIS Scale v1.0 - GI Constipation) Baseline (2 week period) to end of product completion (2 week intervention for each dose and time combination) Response pattern score on PROMIS Scale v1.0 - GI Constipation will be compared between baseline and each intervention period
Trial Locations
- Locations (1)
Personalized Lifestyle Medicine Center
🇺🇸Gig Harbor, Washington, United States