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

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ClinicalTrials.gov Identifier: NCT03259685
Recruitment Status : Recruiting
First Posted : August 24, 2017
Last Update Posted : December 7, 2018
Sponsor:
Information provided by (Responsible Party):
Marie-Claude Vohl, Laval University

Brief Summary:

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.


Condition or disease Intervention/treatment Phase
Gut Microbiota Metabolic Syndrome Other: 710 ml of regular soft drinks, taken daily for 10 weeks Other: 710 ml of diet soft drinks, taken daily for 10 weeks Other: 710 ml of stevia-sweetened soft drinks, taken daily for 10 weeks Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 66 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single (Participant)
Primary Purpose: Prevention
Official Title: Effect of Free Sugar Replacement With Non-nutritive Sweeteners on Metabolic Health of High Sugar Sweetened Beverages Consumers: Potential Role of the Gut Microbiome
Actual Study Start Date : October 18, 2017
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine

Drug Information available for: Stevia

Arm Intervention/treatment
Active Comparator: Regular beverages
Sugar sweetened soft drinks
Other: 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).

Experimental: Diet beverages
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
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.

Experimental: Stevia beverages
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 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.




Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. Changes in intestinal homeostasis of SSB consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks. [ Time Frame: 4-6 months ]
  2. Changes in gut microbiota composition of SSB consumers following regular, diet or stevia-sweetened beverages intakes for 10 weeks. [ Time Frame: 4-6 months ]

Other Outcome Measures:
  1. 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 ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Men and premenopause women in good health
  • Caucasian
  • Daily regular soft drinks consumers (2 or more cans/day)
  • BMI between 25 and 35 kg/m2
  • Waist circumference ≥ 80 cm for women and ≥ 94 cm for men
  • Insulinemia ≥ 60 pmol/L
  • TG ≥ 1.5 mmol/L

Exclusion Criteria:

  • Daily consumption of more than 1 liter of regular soft drinks
  • Regular use of medication
  • Use of antibiotics in the last 3 months
  • Use of natural health product in the last 3 months
  • Nicotine users
  • More than 2 alcohol drinks par day
  • Weight change of more than 5% in the last 3 months
  • Surgery in the last 3 months

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03259685


Contacts
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Contact: Marie-Claude Vohl 418-656-2131 ext 4676 marie-claude.vohl@fsaa.ulaval.ca

Locations
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Canada
Laval University Recruiting
Québec, Canada, G1V0A6
Contact: Marie-Claude Vohl    418-656-2131 ext 4676    marie-claude.vohl@ulaval.ca   
Sponsors and Collaborators
Laval University
Investigators
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Principal Investigator: Marie-Claude Vohl Laval University

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Responsible Party: Marie-Claude Vohl, Professor, Laval University
ClinicalTrials.gov Identifier: NCT03259685     History of Changes
Other Study ID Numbers: SBG 2017-136
First Posted: August 24, 2017    Key Record Dates
Last Update Posted: December 7, 2018
Last Verified: December 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Marie-Claude Vohl, Laval University:
Non-nutritive sweeteners
High Sugar Sweetened Beverages
Diet

Additional relevant MeSH terms:
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Metabolic Syndrome
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases