NCT03983772

Resistant Starch Blend Gastrointestinal Impact

A Pilot Study to Evaluate the Gastrointestinal Response to Increasing Doses of a Resistant Starch Blend in Healthy Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 43 (actual)
• Sponsor: Metagenics, Inc. · Industry
• Sex: All
• Age: 21 Years – 65 Years
• Healthy volunteers: Accepted

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.

Conditions

• Quality of Life
• Health, Subjective

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	RS blend	The intervention is a proprietary resistant starch blend.
OTHER	Placebo	The placebo is starch.

Timeline

• Start date: 2019-06-14
• Primary completion: 2020-12-31
• Completion: 2020-12-31
• First posted: 2019-06-12
• Last updated: 2022-04-06

Locations

1 site across 1 country: United States