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NCT05264636

The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function

Completed NA Last updated 28 April 2023
What this trial tests

NA trial testing Sucrose in Healthy in 59 participants. Completed in 29 August 2022.

Timeline
15 February 2022
Primary endpoint
29 August 2022
29 August 2022

Quick facts

Lead sponsorCargill
PhaseNA
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingquadruple
Primary purposebasic science
Enrollment59
Start date15 February 2022
Primary completion29 August 2022
Estimated completion29 August 2022
Sites1 location across Canada

Drugs / interventions tested

Conditions studied

Sponsor

Cargill — full company profile →

Who can join

Adults 18 to 50, any sex, with Healthy or Human Gut Microflora. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

Diet and dietary ingredients can have a profound effect on gut microflora, both positive and negative. The reported effects on low and non caloric sweeteners (LNCS) on human gut microflora are contradictory in some of the in vitro and rodent studies. More specifically, the latter studies, using doses above the acceptable daily intake (ADI), suggest that LNCS may have adverse effects on gut microflora whereas recent data from human RCTs, using doses at or below the ADI, show little to no effect. In this study we will compare the effects of a low energy beverage made with steviol glycosides vs. a beverage made with sucrose on human gut microflora profile and function in a double blind, randomized study. A sucrose beverage was chosen as a control as it represents a caloric sugar sweetened beverage which is commonly consumed.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Comparison of a Daily Steviol Glycoside Beverage compared with a Sucrose Beverage for Four Weeks on Gut Microbiome in Healthy Adults.
    Kwok D, Scott C, Strom N, Au-Yeung F, et al · · 2024 · cited 10× · PMID 38408729 · DOI 10.1016/j.tjnut.2024.01.032
  2. Health Effects of Sugar-Sweetened and Artificially Sweetened Beverages: Umbrella Review and Evidence-Based Consensus Statement of the Korean Diabetes Association and the Korean Nutrition Society.
    Choi JH, Song S, Kim SK, Cho JW, et al · · 2026 · cited 2× · PMID 41531289 · DOI 10.4093/dmj.2025.0848

Verify or expand the search:

Other trials of Sucrose

Trials testing the same drug.

Other recruiting trials for Healthy

Currently open trials in the same condition.

Other Cargill trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05264636.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing