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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether switching from regular sugar-sweetened drinks to those sweetened with stevia or aspartame affects metabolic health. Researchers aim to determine if these sugar substitutes are healthier or if they might disturb gut health. The study focuses on individuals who regularly consume 4 to 28 cans of soft drinks per week and are otherwise healthy. Participants will help assess if these alternative sweeteners can better reduce cardiometabolic risks. As an unphased trial, this study offers participants the chance to contribute to important research that could lead to healthier dietary recommendations.

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.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that health authorities, such as the FDA, generally consider aspartame, a common artificial sweetener, safe when consumed within certain limits. However, some studies have linked aspartame to risks like metabolic issues and an increased chance of heart-related problems. The World Health Organization has stated that it might cause cancer at high doses, but the daily intake limit is set to avoid these risks.

For stevia, a more natural sweetener, some studies suggest it might aid in blood sugar control and metabolism. However, like aspartame, the findings are mixed. Some research indicates that non-nutritive sweeteners, like stevia, could lead to metabolic problems or weight gain in certain cases.

In summary, both sweeteners have undergone safety studies and are generally approved for use. Still, some studies highlight potential risks, especially with high consumption. Staying informed and making choices based on personal health needs and professional advice is important. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these treatments for metabolic syndrome because they offer a potentially healthier alternative to sugar-sweetened beverages. Aspartame-based and Stevia-sweetened soft drinks use non-nutritive sweeteners, which provide sweetness without the calories, helping to manage weight and reduce the risk of related conditions. Unlike sugar, Stevia is derived from natural plant sources, appealing to those seeking more natural dietary options. These alternatives could provide a way to enjoy sweet flavors without the negative metabolic impacts associated with traditional sugary drinks.

What evidence suggests that this trial's treatments could be effective for metabolic syndrome?

This trial will compare the effects of different sweetened beverages on metabolic syndrome. Participants in one group will consume drinks with aspartame. Some studies have linked aspartame to issues like weight gain and metabolic syndrome, though results remain mixed. Another group will consume drinks sweetened with stevia. Research suggests stevia might have more positive effects, such as lowering blood sugar levels and improving health, especially in individuals who are overweight or have diabetes. Overall, stevia is considered a safer choice with potential benefits for controlling blood sugar and metabolism. ^{2 4 6 7 8}

Who Is on the Research Team?

Marie-Claude Vohl

Principal Investigator

Laval University

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

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]

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]

Citations

1.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC4661066/

METABOLIC EFFECTS OF NON-NUTRITIVE SWEETENERS

In fact, some studies found positive associations between NNS consumption and weight gain, metabolic syndrome, and type 2 diabetes (9–14), although other ...

2.

sciencedirect.com

sciencedirect.com/science/article/pii/S2161831325000857

The Effects of Aspartame on Glucose, Insulin, and Appetite ...

This work identified 100 experiments investigating the effects of aspartame consumption on glucose, insulin and other appetite-regulating hormone responses.

3.

journals.lww.com

journals.lww.com/immunometabolism/fulltext/2025/04000/impacts_of_non_nutritive_sweeteners_on_the_human.3.aspx

Impacts of non-nutritive sweeteners on the human ...

Human cohort studies suggest that NNS contribute to, rather than prevent, metabolic syndrome, whereas randomized controlled trials yield heterogeneous outcomes.

4.

cureus.com

cureus.com/articles/295206-exploring-the-long-term-effect-of-artificial-sweeteners-on-metabolic-health

Exploring the Long-Term Effect of Artificial Sweeteners on ...

High consumption of these sweeteners is linked to a 30% increased risk of metabolic problems, cardiovascular disease, and several types of cancer.

5.

neurology.org

neurology.org/doi/10.1212/WNL.0000000000214023

and No-Calorie Artificial Sweeteners and Cognitive Decline

Consumption of aspartame, saccharin, acesulfame k, erythritol, sorbitol, and xylitol was associated with a faster decline in global cognition, ...

6.

who.int

who.int/news/item/14-07-2023-aspartame-hazard-and-risk-assessment-results-released

Aspartame hazard and risk assessment results released

IARC classified aspartame as possibly carcinogenic to humans (IARC Group 2B) and JECFA reaffirmed the acceptable daily intake of 40 mg/kg body weight.

7.

fda.gov

fda.gov/food/food-additives-petitions/aspartame-and-other-sweeteners-food

Aspartame and Other Sweeteners in Food

FDA scientists do not have safety concerns when aspartame is used under the approved conditions. The sweetener is approved in many countries.

8.

bmj.com

bmj.com/content/378/bmj-2022-071204

Artificial sweeteners and risk of cardiovascular diseases

Aspartame intake was associated with increased risk of cerebrovascular events, and acesulfame potassium and sucralose were associated with ...