An interventional study of 710 ml of regular soft drinks, taken daily for 10 weeks and 710 ml of diet soft drinks, taken daily for 10 weeks in Gut Microbiota and Metabolic Syndrome, sponsored by Laval University. Active, not recruiting at 1 site in Canada. Open to participants aged 18 Years to 75 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-09-03.
Sponsored by Laval University · Not applicable, Interventional, and Prevention
Increasing evidence suggest that artificial sweeteners such as saccharin, aspartame and sucralose may not be as metabolically safe as they first appeared, and it has been proposed that their consumption may be linked to important disturbances in the gut microbiome. Some in vitro and in vivo studies suggest that the recently approved sugar substitute Stevia (eg. steviol glycosides) can also influence intestinal homeostasis. However, it is not clear whether this natural non-nutritive sweetener (NNS) could also cause metabolic and microbiome disturbances as proposed for their synthetic counterparts. In fact, steviol glycosides may even have a beneficial impact on glucose homeostasis and lipid metabolism possibly through a positive action on intestinal health and gut microbiome, but this has yet to be experimentally tested in a rigorous study.
The main objective of this project is to evaluate whether steviol glycosides sweetened beverages (SGSB) or aspartame/acesulfame K sweetened beverages (AASB) exert beneficial, neutral or detrimental effects on metabolic health of regular consumers of sugar-sweetened beverages (SSBs), and whether modulation of the gut microbiome is involved in the resulting impact of these NNSs on metabolic health.
As chronic overconsumption of SSBs is clearly associated with an increased cardiometabolic risk, this study will be the first to determine the metabolic impact of replacing SSBs by potentially "healthier alternatives" such as the increasingly popular stevia-based soft drinks and aspartame-based soft drinks. The investigators will further investigate whether these NNS can cause pernicious effects on intestinal health and the gut microbiome. It is a crucial concern since the importance of this unsuspected key "organ" has been ignored for too long and its important implication in many chronic societal diseases has just been discovered.
Results of this study could have a direct influence on health, nutrition and even agricultural policies as well as dietary guidelines around the world. This project is also critically important as an increasing amount of health professionals such as physicians, nurses and registered dietitians seek to provide evidenced-based guidance to individuals looking for healthier alternatives to SSBs including stevia-based or aspartame-based soft drinks.
Exclusion Criteria:
Sugar sweetened soft drinks
Other: 710 ml of regular soft drinks, taken daily for 10 weeks
Soft drinks sweetened with artificial non-nutritive sweeteners (i.e. aspartame, acesulfame-K)
Other: 710 ml of diet soft drinks, taken daily for 10 weeks
Soft drinks sweetened with natural non-nutritive sweeteners (i.e. steviol glycosides)
Other: 710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks
Subjects will consume regular soft drinks to test if there is a significant difference on the impact on gut microbiota composition and metabolic syndrome parameters between this treatment and the active treatments (diet and stevia beverages).
Subjects will consume diet soft drinks during 10 weeks to test the possible effects of aspartame/acesulfame-K sweetened beverages on gut microbiota composition and on metabolic syndrome parameters.
Subjects will consume soft drinks containing stevia during 10 weeks to test the possible effects of steviol glycosides sweetened beverages on gut microbiota composition and on metabolic syndrome parameters.
Changes in metabolic syndrome parameters including insulin/glucose homeostasis and lipid/lipoprotein metabolism in sugar-sweetened beverages (SSB) consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks.
Time frame: 18-24 months
Changes in intestinal homeostasis of SSB consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks.
Time frame: 4-6 months
Changes in gut microbiota composition of SSB consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks.
Time frame: 4-6 months
Changes in key molecular signaling pathways and metabolic regulatory networks identified through transcriptomics and metabolomics of SSB consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks.
Time frame: 6-12 months
This study is active, not recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Laval University