Resistant Starch Blend Gastrointestinal Impact

Status Completed

Clinical Trial 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.

Clinical Trial 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. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT03983772
Study type	Interventional
Source	Metagenics, Inc.
Contact
Status	Completed
Phase	N/A
Start date	June 14, 2019
Completion date	December 31, 2020

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.