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Effect of Non-nutritive Sweeteners on Vascular Function in Humans

NCT05099393 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2023-12-06

No results posted yet for this study

Summary

In recent decades, low-to-null caloric, non-nutritive sweeteners (NNS) have been increasingly used, replacing and offering an alternative to food and beverages sweetened by high-energy, added sugars. Indeed, by providing consumers with products that have a sweet taste with low energy content, NNS appear to be the magic bullet to enhance weight loss and reduce cardio-metabolic diseases. However, a recent meta-analysis of randomized trials does not show any benefit of NNS consumption on body weight loss. Moreover, epidemiological, descriptive and experimental studies have recently reported that NNS consumption is paradoxically associated with weight gain, glucose intolerance and increased risk of type 2 diabetes and/or cardiovascular events. Among the approved NNS, sucralose and AceK, both high intensity (respectively \~500-600 and 200 times sweeter than sugar) are the most widely used in foods and drinks, accounting more than 62 % of the global artificial sweetener market. Recent experimental data show an effect of sucralose and AceK (and other NNS) consumption on vascular reactivity in response to a physiological stress (hyperglycemic load) in rats. Since sweet taste receptors (T1R) have been recently found in the endothelium, investigators hypothesize that NNS, and especially sucralose and AceK, a potent T1R agonist, impairs micro- and macrovascular reactivity in humans, which, to the best of our knowledge, has never been explored.

Conditions

  • Non Nutritive Sweeteners Consumption

Interventions

DIETARY_SUPPLEMENT

Non Nutritive Sweeteners

The 2 arms will participate in 3 periods and each of these periods will correspond to the intake of either sucralose, AceK or a placebo. The order will be defined randomly. There will be 3 periods and each period will last 4 weeks. 7 to 14 days of break will be respected between each period.

Sponsors & Collaborators

  • University Hospital, Grenoble

    lead OTHER

Principal Investigators

  • Matthieu ROUSTIT, Pr · Centre hospitalier universitaire grenoble alpes

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
CROSSOVER

Eligibility

Min Age
18 Years
Max Age
100 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2022-03-28
Primary Completion
2024-10-31
Completion
2024-11-30

Countries

  • France

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05099393 on ClinicalTrials.gov