Non-nutritive Sweeteners for Metabolic Syndrome

Overseen By Marie-Claude Vohl

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Laval University

Must not be taking: Antibiotics, others

Disqualifiers: Hypertension, Diabetes, Hypercholesterolemia, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

41 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but if you regularly use medication that affects the study parameters, you may not be eligible to participate.

What data supports the effectiveness of the treatment Aspartame-based soft drinks, Regular soft drinks, Stevia-sweetened soft drinks for Metabolic Syndrome?

Research suggests that non-nutritive sweeteners like aspartame and stevia can be used as alternatives to sugar-sweetened beverages, as they do not significantly affect blood sugar or insulin levels, making them a potential strategy for managing metabolic health. ^{1 2 3 4 5}

Are non-nutritive sweeteners like aspartame and stevia safe for human consumption?

Research shows that non-nutritive sweeteners such as aspartame and stevia are generally considered safe by food safety authorities worldwide. Studies have not found significant harmful effects on blood sugar, insulin levels, cholesterol, or body weight, suggesting they are safe for human consumption. ^{1 4 5 6 7}

How do Aspartame-based and Stevia-sweetened soft drinks differ from other treatments for metabolic syndrome?

Aspartame-based and Stevia-sweetened soft drinks offer a unique approach to managing metabolic syndrome by replacing sugar-sweetened beverages with non-nutritive sweeteners, potentially reducing sugar intake without significantly affecting weight or metabolic parameters. Stevia, in particular, may help with glycemic control and weight management, making it a novel option compared to traditional sugar-based drinks. ^{1 3 5 7 8}

What is the purpose of this trial?

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.

Research Team

Marie-Claude Vohl

Principal Investigator

Laval University

Eligibility Criteria

This trial is for men and women who are generally healthy and regularly consume soft drinks, ranging from 4 cans a week up to 4 cans a day. It's not suitable for those with recent surgeries, allergies to drink ingredients, recent antibiotic use, heavy alcohol consumption, or changes in medication or weight.

Inclusion Criteria

People who drink between 4 cans of soft drinks per week to 4 cans per day.

I am in good health.

Exclusion Criteria

I have not had surgery in the last 3 months and do not plan to during the study.

You are allergic or intolerant to any ingredients in soft drinks.

I have a condition like high blood pressure, diabetes, or high cholesterol.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants consume either sugar-sweetened beverages, artificial sweetener beverages, or stevia-sweetened beverages to evaluate metabolic and gut microbiome effects

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aspartame-based soft drinks
• Regular soft drinks
• Stevia-sweetened soft drinks

Trial Overview The study tests the effects of daily consumption of three types of beverages over 10 weeks: regular sugary soft drinks, diet soft drinks with artificial sweeteners like aspartame, and stevia-sweetened soft drinks on metabolic health and gut microbiome.

Participant Groups

Group I: Stevia beverages Experimental Treatment 1 Intervention

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

Group II: Diet beverages Experimental Treatment 1 Intervention

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

Group III: Regular beverages Active Control 1 Intervention

Sugar sweetened soft drinks

Who Is Running the Clinical Trial?

Laval University

Lead Sponsor

Trials

439

Recruited

178,000+

Findings from Research

In a 6-month intervention study with 101 participants, there was a significant increase in non-nutritive sweetener (NNS) consumption, particularly aspartame and total NNS, suggesting that NNS may help reduce sugar-sweetened beverage (SSB) intake.

Despite the increase in NNS consumption, there were no significant changes in weight or body mass index (BMI) among different SSB-NNS change groups, indicating that while NNS can be used to decrease SSB consumption, their impact on weight management may need further investigation.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention. Acero, D., Zoellner, JM., Davy, BM., et al.[2021]

A systematic review and meta-analysis of 29 studies found that aspartame consumption does not significantly affect key metabolic parameters such as blood glucose, insulin levels, cholesterol, triglycerides, or body weight, suggesting it does not provide metabolic benefits for diabetes or obesity.

The analysis indicated that aspartame does not alter energy intake compared to control or sucrose, reinforcing the idea that it may not be beneficial for weight management or metabolic health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Metabolic effects of aspartame in adulthood: A systematic review and meta-analysis of randomized clinical trials. Santos, NC., de Araujo, LM., De Luca Canto, G., et al.[2023]

Steviol glycoside sweeteners from the Stevia plant are gaining popularity as low- and no-calorie sweeteners due to their plant-based origin, zero calories, and sweetness that is 50-350 times greater than sugar, making them suitable for reducing sugar intake in food and beverages.

Despite being affirmed as safe by various food regulatory authorities, there is still a lack of education about stevia's safety and benefits, which affects its acceptance among health professionals and consumers.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Stevia Leaf to Stevia Sweetener: Exploring Its Science, Benefits, and Future Potential. Samuel, P., Ayoob, KT., Magnuson, BA., et al.[2023]

References

1. Switzerland pubmed.ncbi.nlm.nih.gov

Changes in Non-Nutritive Sweetener Consumption Patterns in Response to a Sugar-Sweetened Beverage Reduction Intervention. [2021]

2. Switzerland pubmed.ncbi.nlm.nih.gov

The Effect of Non-Nutritive Sweetened Beverages on Postprandial Glycemic and Endocrine Responses: A Systematic Review and Network Meta-Analysis. [2023]

3. England pubmed.ncbi.nlm.nih.gov

Hormonal responses to non-nutritive sweeteners in water and diet soda. [2022]

4. Canada pubmed.ncbi.nlm.nih.gov

Nonnutritive sweeteners and cardiometabolic health: a systematic review and meta-analysis of randomized controlled trials and prospective cohort studies. [2022]

5. United States pubmed.ncbi.nlm.nih.gov

Metabolic effects of aspartame in adulthood: A systematic review and meta-analysis of randomized clinical trials. [2023]

6. United States pubmed.ncbi.nlm.nih.gov

Stevia Leaf to Stevia Sweetener: Exploring Its Science, Benefits, and Future Potential. [2023]

7. England pubmed.ncbi.nlm.nih.gov

The use of alternative sweeteners (sucralose and stevia) in healthy soft-drink beverages, enhances the bioavailability of polyphenols relative to the classical caloric sucrose. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

Comparative effects of commonly used commercially available non-nutritive sweeteners on diabetes-related parameters in non-diabetic rats. [2021]