Sucralose for Healthy Subjects

(SWEET Trial)

Overseen By Julianna Blagih, PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Caroline Lamarche

Must not be taking: Regular medication

Disqualifiers: Autoimmune disease, Pregnancy, others

Compensation: Varies

Number of Visits: 4

Duration: 4 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether sucralose, a common artificial sweetener, can help the immune system better accept new kidney transplants. Researchers aim to determine if sucralose can boost helpful immune cells (Tregs) that protect the kidney while reducing harmful ones that cause rejection. The study involves healthy volunteers taking sucralose and a placebo to compare effects. Individuals who are generally healthy and not on regular medications, other than contraceptives, might be suitable candidates. The results could lead to safer methods for preventing kidney rejection without the side effects of current drugs. As an unphased trial, this study offers a unique opportunity to contribute to groundbreaking research that could improve transplant outcomes.

Will I have to stop taking my current medications?

Yes, you will need to stop taking any regular medications, except for contraceptive pills, to participate in this trial.

Is there any evidence suggesting that sucralose is likely to be safe for humans?

Research has shown that sucralose is generally safe for consumption. The FDA has approved it as a sugar substitute for both children and adults, including those with diabetes. Sucralose appears in many food products and is considered safe. Studies have found no evidence that sucralose causes cancer or other harm in humans. However, some research on mice suggested that sucralose might affect the immune system in unexpected ways. These findings have not been confirmed in humans, so more research is needed to fully understand these effects. Overall, most people tolerate sucralose well. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Sucralose is unique because it's a non-nutritive sweetener commonly used in place of sugar, and researchers are exploring its effects on health beyond its role as a sugar substitute. Unlike other treatments that focus on directly managing specific conditions with active drugs or therapies, sucralose offers a novel approach by potentially altering metabolic responses without contributing calories. This trial could reveal unexpected benefits or effects of sucralose on health, offering fresh insights into how non-nutritive sweeteners might be used in broader health strategies.

What evidence suggests that sucralose might be an effective treatment for kidney transplant rejection?

This trial will investigate the effects of sucralose in healthy subjects. Research has shown that sucralose, a common artificial sweetener, might help the immune system accept kidney transplants more easily. In studies with mice, high amounts of sucralose lowered the activity of T cells, which are linked to organ rejection, while increasing regulatory T cells (Tregs) that help protect transplants. This suggests sucralose could make the immune system less likely to attack a new kidney. Although these findings are promising, they have mostly been observed in animal studies, and the effects on humans remain under investigation. ^{1 6 7 8 9}

Are You a Good Fit for This Trial?

This trial is for healthy volunteers interested in contributing to research on how sucralose, an artificial sweetener, might influence the immune system. Participants will take sucralose or a placebo pill twice daily for one month, with a two-week break before switching treatments.

Inclusion Criteria

Body weight comparable to average reported in Canada

Exclusion Criteria

Past medical history of autoimmune disease

Pregnant women

I only use contraceptive pills regularly, no other medications.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2 weeks

Treatment

Participants receive either sucralose or placebo as a pill twice daily for 4 weeks

4 weeks

Blood samples taken at the beginning and after 4 weeks

Washout

Participants stop taking the pills for a washout period

2 weeks

Crossover Treatment

Participants switch treatments: those on sucralose switch to placebo and vice versa for another 4 weeks

4 weeks

Blood samples taken after the washout and at the end of the study

Follow-up

Participants are monitored for changes in immune system markers after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Sucralose

Trial Overview The study aims to see if sucralose can increase regulatory T cells (Tregs), which help prevent organ rejection after transplants. It involves taking pills and providing blood samples over several months to monitor changes in the immune system.

How Is the Trial Designed?

Group I: Starting with sucralose - washout - placebo. Active Control 2 Interventions

This group will start with sucralose (4 weeks) , then will have a washout period (2 weeks) and then will test the placebo (4 weeks)

Group II: Starting with placebo - washout - sucralose. Placebo Group 2 Interventions

This group will start with a placebo (4 weeks) , then will have a washout period (2 weeks) and then will test sucralose (4 weeks)

Who Is Running the Clinical Trial?

Caroline Lamarche

Lead Sponsor

Ciusss de L'Est de l'Île de Montréal

Collaborator

Trials

81

Recruited

6,400+

Citations

1. sciencedirect.com sciencedirect.com/science/article/pii/S0002916522029641

Sucralose decreases insulin sensitivity in healthy subjects Individuals assigned to sucralose consumption showed a significant decrease in insulin sensitivity with a median (IQR) percentage change of −17.7% (−29.3% to − ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10971371/

Sucralose: From Sweet Success to Metabolic Controversies ... Sucralose is a food additive initially used to mitigate glycemic peaks and calorie intake in patients with diabetes and obesity.

3. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/30535090/

Sucralose decreases insulin sensitivity in healthy subjects Results: Individuals assigned to sucralose consumption showed a significant decrease in insulin sensitivity with a median (IQR) percentage ...

4. frontiersin.org frontiersin.org/journals/nutrition/articles/10.3389/fnut.2024.1387646/full

Unveiling the profound influence of sucralose on ... Sucralose decreases insulin sensitivity in healthy subjects: a randomized controlled trial. Am J Clin Nutr. (2018) 108:485–91. doi: 10.1093/ajcn/nqy152.

5. nature.com nature.com/articles/s41586-023-05801-6

The dietary sweetener sucralose is a negative modulator of ... In this study, we show that the intake of high doses of sucralose in mice results in immunomodulatory effects by limiting T cell proliferation and T cell ...

6. sciencedirect.com sciencedirect.com/science/article/pii/S0278691517302818

Critical review of the current literature on the safety ... Collectively, critical review of the extensive database of research demonstrates that sucralose is safe for its intended use as a non-caloric sugar alternative.

7. kentscientific.com kentscientific.com/new-research-with-mice-reveals-the-dangers-of-sweeteners/?srsltid=AfmBOoohOi3hrNb8KhKQ9hKC6DSnRil1_ikzBWAnCooH8C8bokFoohpf

New Research with Mice Reveals the Dangers of ... When the researchers exposed human blood cells to sucralose-6-acetate, they found that it damages DNA, which could increase the risk for cancer ...

8. cancer.gov cancer.gov/about-cancer/causes-prevention/risk/diet/artificial-sweeteners-fact-sheet

Artificial Sweeteners and Cancer - NCI The results of these studies showed no evidence that these sweeteners cause cancer or other harms in people.

9. ific.org ific.org/insights/everything-you-need-to-know-about-sucralose/

Everything You Need to Know About Sucralose - IFIC ... sucralose is safe for adults and children to consume within the ADI. ... Sucralose Consumption over 2 Weeks in Healthy Subjects Does Not ...