Impact of non-nutritive sweeteners on blood vessel function
Effect of Non-nutritive Sweeteners on Vascular Function in Humans
This study is testing how non-nutritive sweeteners like sucralose and AceK affect blood vessel function in people, especially when their blood sugar levels are high.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 40 (estimated) |
| Ages | 18 Years to 100 Years |
| Sex | All |
| Sponsor | University Hospital, Grenoble Academic / other |
| Locations | 1 site (Grenoble) |
| Trial ID | NCT05099393 on ClinicalTrials.gov |
What this trial studies
This study investigates the effects of non-nutritive sweeteners (NNS) like sucralose and AceK on vascular function in humans. It aims to understand how these sweeteners, commonly used as sugar substitutes, may influence blood vessel reactivity, particularly in response to physiological stress such as hyperglycemic load. The research will involve a single-center, controlled approach to assess the vascular responses of participants consuming these sweeteners. The study is motivated by recent findings suggesting that NNS consumption may be linked to adverse health outcomes, including weight gain and increased risk of cardiovascular events.
Who should consider this trial
Good fit: Ideal candidates for this study are adults aged 18 and older with a BMI between 18.5 and 30 kg/m² or those with obesity (BMI >30 kg/m²).
Not a fit: Patients with chronic diseases affecting vascular function, such as type 2 diabetes, or those who smoke may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into the safety and health implications of consuming non-nutritive sweeteners, potentially guiding dietary recommendations.
How similar studies have performed: While there have been studies on the effects of non-nutritive sweeteners, this specific investigation into their impact on vascular function in humans is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Male or female aged≥ 18 years * Signed informed consent * Body mass index: * 25 kg/m² ≥ BMI ≥ 18,5 kg/m² (lean subjects) * \>30 kg/m2, with waist-to-hip ratio \>0.9 (subjects with obesity) * Person who is affiliated to a social security scheme or who is a beneficiary of such a scheme Exclusion Criteria: * Any chronic disease with vascular impact (including type 2 diabetes) * Active tobacco use (any quantity) * Participant involved in another interventional clinical study * History of hypersensitivity reaction to products used * The persons mentioned in articles L1121-5 to L1121-9 of the public health code may not be included in this research (Pregnancy or Lactation ; Females with childbearing potential, defined as a premenopausal female and not using an effective form of birth control. (Effective birth control methods include: oral, implant or patch hormone contraception; intrauterine device; abstinence and outercourse; tubal ligation; vasectomy.) ; Person deprived of liberty by judicial order ; Person under guardianship or curatorship ; Minors ; Adults who are incapable or unable to give their consent ; Cross-over situations) * Subject who would receive more than 4500 euros in compensation due to his or her participation in other research involving the human person in the 12 months preceding this study
Where this trial is running
Grenoble
- Grenoble University hospital — Grenoble, France (Recruiting)
Study contacts
- Principal investigator: Matthieu ROUSTIT, Pr — Centre hospitalier universitaire grenoble alpes
- Study coordinator: Matthieu ROUSTIT, Pr
- Email: MRoustit@chu-grenoble.fr
- Phone: 04 76 76 92 60
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.