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Effect of Non-nutritive Sweeteners of High Sugar Sweetened Beverages on Metabolic Health and Gut Microbiome

NCT ID: NCT03259685

Last Updated: 2025-12-26

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-10-18

Study Completion Date

2025-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gut Microbiota Metabolic Syndrome

Keywords

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Non-nutritive sweeteners High Sugar Sweetened Beverages Diet

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Regular beverages

Sugar sweetened soft drinks

Group Type ACTIVE_COMPARATOR

710 ml of regular soft drinks, taken daily for 10 weeks

Intervention Type OTHER

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).

Diet beverages

Soft drinks sweetened with artificial non-nutritive sweeteners (i.e. aspartame, acesulfame-K)

Group Type EXPERIMENTAL

710 ml of diet soft drinks, taken daily for 10 weeks

Intervention Type OTHER

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.

Stevia beverages

Soft drinks sweetened with natural non-nutritive sweeteners (i.e. steviol glycosides)

Group Type EXPERIMENTAL

710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks

Intervention Type OTHER

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.

Interventions

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710 ml of regular 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).

Intervention Type OTHER

710 ml of diet soft drinks, taken daily for 10 weeks

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.

Intervention Type OTHER

710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks

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.

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* Men and women in good health
* Soft drinks consumers (between 4 cans/week to 4 cans/day)

Exclusion Criteria

* Metabolic disorders (hypertension, diabetes, hypercholesterolemia)
* Daily consumption of more than 4 cans of soft drinks
* Regular use of medication affecting study parameters
* Change of medication (type or dose) in the last year
* Use of antibiotics in the last 3 months
* Change in natural health product use in the last 3 months
* More than 2 alcohol drinks par day
* Weight change of more than 5% in the last 3 months
* Surgery in the last 3 months or planed during the study
* Allergy or intolerance for products contained in soft drinks
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Laval University

OTHER

Sponsor Role lead

Responsible Party

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Marie-Claude Vohl

Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Marie-Claude Vohl

Role: PRINCIPAL_INVESTIGATOR

Laval University

Locations

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Laval University

Québec, , Canada

Site Status

Countries

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Canada

References

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Bergwall S, Johansson A, Sonestedt E, Acosta S. High versus low-added sugar consumption for the primary prevention of cardiovascular disease. Cochrane Database Syst Rev. 2022 Jan 5;1(1):CD013320. doi: 10.1002/14651858.CD013320.pub2.

Reference Type DERIVED
PMID: 34986271 (View on PubMed)

Other Identifiers

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SBG 2017-136

Identifier Type: -

Identifier Source: org_study_id