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NCT05264636
The Impact of Steviol Glycosides on Human Gut Microflora Profile and Function
NA trial testing Sucrose in Healthy in 59 participants. Completed in 29 August 2022.
29 August 2022
Quick facts
| Lead sponsor | Cargill |
|---|---|
| Phase | NA |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | quadruple |
| Primary purpose | basic science |
| Enrollment | 59 |
| Start date | 15 February 2022 |
| Primary completion | 29 August 2022 |
| Estimated completion | 29 August 2022 |
| Sites | 1 location across Canada |
Drugs / interventions tested
- Sucrose — full drug profile →
- Steviol Glycosides
Conditions studied
- Healthy — all drugs for Healthy →
- Human Gut Microflora — all drugs for Human Gut Microflora →
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):
-
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 -
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:
- PubMed search for NCT05264636
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
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Other Cargill trials
Trials by the same sponsor.
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Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05264636 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Cargill
- Last refreshed: 28 April 2023
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