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Clinical trialNCT04005924CompletedInterventional

Effect of an Arabinogalactan Product

SponsorBiofortis, Merieux NutriSciencesEnrollment20Postprandial Blood Glucose
View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

Dietary fiber is an important nutrient that supports gastrointestinal function as well as blood glucose and cholesterol maintenance. The National Academy of Sciences Institute of Medicine (IOM) established an adequate intake for fiber as 14 g/kcal, or 38 g and 25 g for men and women, respectively. Currently, however, the majority of the U.S. population falls substantially below this level, with mean intakes of 18.9 g/day and 15.7 g/day in men and women age 20 and older, respectively. Fiber is a complex category that contains a number of different polysaccharides and oligosaccharides that are not digested in the upper gastrointestinal tract. In its final rule updating the Nutrition and Supplement Facts label regulations, which was published in May 2016, the U.S. FDA revised the definition of dietary fiber for food labeling and included two categories: (1) the intrinsic and intact non-digestible carbohydrate (NDC) and lignin, and (2) the isolated or synthesized NDC. In this re-definition, those NDCs that are isolated from plant and other food sources will now require clinical data indicating that the ingredient provides a physiological effect that is beneficial to human health. This study is designed to test the effect of an isolated NDC, arabinogalactan, on attenuation of blood glucose and/or insulin. Attenuation of blood glucose and/or insulin is one of the outcomes identified by the U.S. FDA as a physiological effect that is beneficial to human health, and as such, can be used to support that an isolated NDC is acting as a fiber (FDA 2018). Arabinogalactans are hemicelluloses that are abundant in plants. Arabinogalactans are found in seeds, leaves, roots, and fruit of higher plants, such as cereals, beans, leeks, pear, corn, and wheat (Saeed 2011; Dion 2016). The arabinogalactan ingredient used in the study is isolated from larch (Larix laricina) using a patented water-based extraction process. Larch arabinogalactan has been designated as Generally Recognized as Safe (GRAS) by the U.S. FDA (2000) 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. The present study was designed with the goal to assess the effect of acute consumption of arabinogalactan on blood glucose and insulin responses.

Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

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Sites

1 registered facility, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States
  • Oliver Chen

    Addison, Illinois, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

No drug or biological interventions are in our data for this study. It may test a procedure, device or behavioral intervention, or the intervention list isn't in our current snapshot. See the registry record ↗. Why? →

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start
6 May 2019
Primary completion
19 Aug 2019
Completion
8 Oct 2019
Last update posted
21 Jul 2021
Registered enrollment
20
Registry id
NCT04005924

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.