NCT03058575

Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome

A Randomized, Controlled, Crossover Study to Evaluate the Effects of a Novel Food Product Containing Microbiota Accessible Carbohydrates on the Human Microbiome and Associated Parameters

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 30 (actual)
• Sponsor: Access Business Group · Industry
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Accepted

Summary

This is a randomized, 2-period crossover study aimed at assessing the effect of taking a food supplement containing a blend of microbial accessible carbohydrates on the diversity of the gut microbiome. Impacts to the skin, scalp and oral microbiomes; blood inflammatory biomarkers; quality and quantity of sleep; gastrointestinal quality of life; bowel habits, and facial skin features will also be evaluated.

Detailed description

The human body is home to trillions of microbes, which have been shown to play important roles in many aspects of human biology, such as immune function and metabolism. Research in this area has primarily focused on the role that dietary factors have in modulating the gastrointestinal (GI) microbiota with associated changes in host health parameters. Specifically, dietary microbiota accessible carbohydrates (MACs), which include compounds such as resistant starches and other dietary fibers that are typically resistant to digestion, have been shown to serve as a primary source of energy for the distal gut microbiota. Metabolism of MACs by the GI microbiota is important in shaping this microbial ecosystem. A Western diet, typically low in MAC content (e.g., dietary fiber), is associated with a marked reduction in microbial diversity and depletion of specific types of potentially beneficial microbes. Until only recently, the bulk of microbiota studies have been conducted in animals, and human studies on the GI microbiota have focused primarily on delineating the gut bacterial composition and corresponding changes in taxonomy in response to a particular dietary intervention (e.g., with prebiotics). Additionally, investigations on dietary factors influencing the skin (or scalp) and oral cavity microbiomes have only recently garnered attention. Human intervention studies that increase consumption of dietary MACs are needed to better understand how changes in the composition and function of these bacteria influence host parameters.

Conditions

• Gut Microbiome

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	Dietary MACs	All subjects will have a dose-escalation period when randomized to the active arm that will occur as follows: Day 1: 1 scoop of product (morning, in the clinic) Day 2: 1 scoop of product (morning) Day 3: 2 scoops of product (morning and evening) Day 4: 2 scoops of product (morning and evening) Days 5-60: 3 scoops of product (morning, afternoon, evening) Other Names: Dietary fiber supplement
OTHER	Control	No Intervention for 8 weeks

Timeline

• Start date: 2017-01-16
• Primary completion: 2017-07-11
• Completion: 2017-09-30
• First posted: 2017-02-23
• Last updated: 2018-01-23

Locations

1 site across 1 country: United States