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To Investigate the Effect of Arabinogalactan on the Gut Microbiome in Adults

NCT04351841 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 30

Last updated 2020-04-22

No results posted yet for this study

Summary

Dietary fiber is an important nutrient that supports gastrointestinal function, as well as the maintenance of blood glucose and cholesterol. Additionally, it is suggested that dietary fiber may provide other health benefits, such as maintenance of healthy weight through effects on satiety. Furthermore, dietary fiber can improve health by modulating the microbial communities residing in human gut, particularly in the large intestine. The microbes in the gut modulate a wide variety of biological processes essential for health of the host. Currently, the average intake of fiber in the U.S. is \~40-50% below adequate intake levels.

ResitAid, a Lonza's arabinogalactan, is a hemicellulose that is abundant in plants. Arabinogalactans including ResitAid are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, bark, and wheat. ResitAid, the arabinogalactan ingredient used in this study, is isolated from larch (Larix laricina) using a patented water-based extraction process. ResitAid has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA for multiple uses and has been used in numerous previous clinical studies in humans, with no significant safety issues observed at intakes of up to 30 g daily for up to 6 weeks. It was reported that 15 g and 30 g of different preparation of arabinogalactan could significantly increase certain microbial populations considered to be beneficial (e.g., Lactobacillus spp.). Nevertheless, more clinical evidence is needed to support the effect of ResistAid on the microbial composition in the gut. This study is designed to investigate the effect of daily consumption of 15 g of ResitAid on the gastrointestinal microbial profile and fecal short-chain fatty acid contents in healthy adults.

Primary Objective: Modulation of the microbiome

Secondary objectives:

1. Changes in Lactobacillus ssp.
2. Changes in Bifidobacterium ssp.
3. Changes in SCFA
4. Changes in bowel movement
5. Changes in the SF-36 questionnaire

Conditions

  • Gut Microbiota

Interventions

OTHER

arabinogalactan

A beverage will be prepared by thoroughly mixing the 15 g of arabinogalactan with water and Crystal Light flavoring

OTHER

maltodextrin

A beverage will be prepared by thoroughly mixing the 15 g of maltodextrin with water and Crystal Light flavoring

Sponsors & Collaborators

  • Lonza Inc.

    collaborator INDUSTRY

  • Biofortis, Merieux NutriSciences

    lead INDUSTRY

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
60 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2019-08-05
Primary Completion
2019-12-18
Completion
2019-12-18

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04351841 on ClinicalTrials.gov