Non Nutritive Sweeteners ConsumptionSOSweetNCT05099393
Effect of Non-nutritive Sweeteners on Vascular Function in Humans
A study testing Non Nutritive Sweeteners in people with Non Nutritive Sweeteners Consumption, run by University Hospital, Grenoble at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 100 yearsHealthy volunteers can take part
- Conditions the study is for
- Non Nutritive Sweeteners Consumption
- What is being tested?
- Non Nutritive Sweeteners
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteFrance
- Study dates
- 28 Mar 2022to Nov 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 100 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Grenoble University hospital
Grenoble
Guigui alicia, aguigui@chu-grenoble.fr
About this study
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.
Read the detailed description
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.
This is a prospective, single-center, controlled, randomized, double-blind, three-period crossover study
The principal objective is to evaluate the effect of a NNS daily consumption (sucralose or AceK) during 4 weeks on macrovascular endothelial function, in lean and obese subjects compared to placebo.
The principal outcome / endpoint will be based on flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected for shear rate, according to current recommendations, after 4 week of NNS (sucralose or AceK) daily consumption compared to placebo
CONDUCT OF THE RESEARCH : Patients will be screened and, if eligible, proposed a 3-period crossover trial (sucralose, AceK, placebo). The order will be randomized. These 3 periods will be separated with wash out periods between one and two weeks. The 3 periods of 4 weeks will be with one visit at the beginning and at the end of each period, i.e. a total of 6 visits. During each beginning and end of period visit, microvascular and macrovascular reactivity tests will be conducted. At the first visit only, microdialysis will be performed.
Number of subjects : 40 Length of the inclusion period: 24 months Length of treatment: 3 one-month periods, and maximum 4 weeks of wash-outs Length of participation for each subject: 4 months Total length of the study (with statistical analysis): 36 months
STATISTICAL ANALYSIS ; The analysis of the primary outcome will be carried on using an analysis of covariance (ANCOVA), adjusted on baseline FMD, with a risk alpha of 0.05 and a power of 80%, two-sided. Investogators estimated within-subject correlation to be close to 0.7, as shown in previous results by our group.5 In order to maximise power, for secondary objectives, the effects of sucralose, AceK, sex, and obesity, will be assessed using mixed-effects models, with the subject as a random factor.
EXPECTED IMPACT : This is a hot topic since recent studies in animals and humans do not support the claims previously submitted to regulatory agencies that NNS, including sucralose and AceK, are stable compounds that are not metabolized in vivo; and have no effect on metabolism. Questioning the physiological inactivity of these extensively used molecules is mandatory since there is a rise in the consumption of NNS-containing products. Moreover, very recent studies are observing an increase in the consumption of diet products, especially in vulnerable groups (obese, diabetic patients, children or pregnant women). New data on the effect of chronic NNS consumption will help revisit the regulatory status of NNS and bring extensive knowledge on the role of T1R receptors on vascular function, which has been hardly ever studied so far. Finally and importantly, vascular function is largely recognized as a strong precursor of cardiovascular disease.
- Conditions
- Non Nutritive Sweeteners Consumption
- Being tested
- Non Nutritive Sweeteners
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non Nutritive SweetenersDietary supplement
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.
| Study group | Role | What they receive |
|---|---|---|
| subject with obesity | Experimental | composed of subject with obesity (Body mass index > 30) Receives: Dietary Supplement: Non Nutritive Sweeteners |
| lean subject | Experimental | composed of healthy volunteers (Body mass index < 30) Receives: Dietary Supplement: Non Nutritive Sweeteners |
What is being measured
The primary outcome is the main question the study is designed to answer.
Macrovascular endothelial function
Flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected for shear rate, according to current recommendations,6 after 4 week of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Secondary outcomes (28)
Macrovascular non-endothelial function
Nitrate-mediated dilation (NMD), expressed as a percent change from baseline diameter, and corrected on the shear rate, in accordance with guidelines, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Macrovascular endothelial function
Flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected on the shear rate, in accordance with guidelines, in response to a glycemic stress, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Macrovascular non endothelial function
Nitrate-mediated dilation (NMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected on the shear rate, in accordance with guidelines, in response to a glycemic stress, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial function
Microvascular reactivity to iontophoresis of acetylcholine (ACh), measured with laser speckle contrast imaging (LSCI), after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular non endothelial function
Microvascular reactivity to iontophoresis of sodium nitroprussiate (SNP), measured with laser speckle contrast imaging (LSCI), after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Microvascular reactivity to local thermal heating, measured with laser speckle contrast imaging (LSCI), after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial function
Microvascular reactivity to iontophoresis of acetylcholine (ACh), measured with laser speckle contrast imaging (LSCI), in response to a glycemic stress, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular non endothelial function
Microvascular reactivity to iontophoresis of sodium nitroprussiate (SNP), measured with laser speckle contrast imaging (LSCI), in response to a glycemic stress, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Microvascular reactivity to local thermal hyperheamia, measured with laser speckle contrast imaging (LSCI), in response to a glycemic stress, after 4 weeks of NNS (sucralose or AceK) daily consumption compared to placebo.
Measured: through study completion, an average of 4 months
Macrovascular endothelial function
Flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected on the shear rate, in accordance with guidelines 2 hours after an acute intake of NNS (sucralose or AceK) compared to placebo
Measured: through study completion, an average of 4 months
Macrovascular non endothelial function
Nitrate-mediated dilation (NMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected on the shear rate, in accordance with guidelines 2 hours after an acute intake of NNS (sucralose or AceK) compared to placebo
Measured: through study completion, an average of 4 months
Microvascular non endothelial function
Microvascular reactivity to iontophoresis of SNP, measured with laser speckle contrast imaging (LSCI), one hour and a half after an acute intake of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial function
Microvascular reactivity to iontophoresis of Ach, measured with laser speckle contrast imaging (LSCI), one hour and a half after an acute intake of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Microvascular reactivity to local thermal hyperhemia measured with laser speckle contrast imaging (LSCI) one hour and a half after an acute intake of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of ghrelin, after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of gastric inhibitory peptide (GIP), after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of glucagon like peptide (GLP-1), after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of peptide tyrosine tyrosine (PYY), after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of cholecystokinin (CCK), after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Plasma levels of leptin after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolic function
Glycaemia, after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Metabolomics profiles
Plasma metabolomics profile after 4 weeks daily consumption of NNS (sucralose or AceK) compared to placebo.
Measured: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Results of FMD, NMD, local thermal hyperaemie (LTH) and iontophoresis of Ach and SNP compared between lean and obese subjects, in response to an acute or daily consumption of NNS (sucralose or AceK) or placebo.
Measured: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Results of FMD, NMD, LTH, and iontophoresis of Ach and SNP, compared between male and female subjects, in response to an acute or daily consumption of NNS (sucralose or AceK) or placebo.
Measured: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Results of FMD, NMD, LTH and iontophoresis of Ach and SNP, according to the basal consumption of sweetener, in response to an acute or daily consumption of NNS (sucralose or AceK) or placebo.
Measured: through study completion, an average of 4 months
Microdialysis reactivity
Microvascular reactivity by microdialysis of sucralose measured with laser speckle contrast imaging (LSCI)
Measured: First visit, one day
Microdialysis reactivity
Microvascular reactivity by microdialysis of AceK measured with laser speckle contrast imaging (LSCI)
Measured: First visit, one day
Microdialysis reactivity
Microvascular reactivity by microdialysis of lactisole measured with laser speckle contrast imaging (LSCI)
Measured: First visit, one day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Oct 2021
- Study start28 Mar 2022
- Primary completionOct 2024 (estimated)
- Study completionNov 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Non Nutritive Sweeteners ConsumptionStudies of the same condition, open and under way.
- More trials run by University Hospital, GrenobleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Model description
- Prospective, single-center, controlled, randomized, double-blind, three-period crossover study
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Grenoble
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Matthieu ROUSTIT, Pr, Principal investigator, Centre hospitalier universitaire grenoble alpes
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05099393
- Sponsor's protocol ID
- 38RC19.355
- Acronym
- SOSweet
- Status last verified
- Dec 2023
- First submitted
- 29 Sep 2021
- Last updated
- 6 Dec 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Data can be requested by contacting Prof. Roustit mroustit@chu-grenoble.fr
Study at a glance
From the registry record, last updated by the sponsor on 6 Dec 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-nutritive Sweeteners on Vascular Function in Humans
- ClinicalTrials.gov ID
- NCT05099393
- Acronym / sponsor ID
- SOSweet / 38RC19.355
- Conditions
- Non Nutritive Sweeteners Consumption
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- University Hospital, GrenobleUniversity, hospital or other
- Study start
- 28 Mar 2022 (actual)
- Primary completion
- Oct 2024 (estimated)
- Study completion
- Nov 2024 (estimated)
- First posted
- 29 Oct 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
This is a prospective, single-center, controlled, randomized, double-blind, three-period crossover study
The principal objective is to evaluate the effect of a NNS daily consumption (sucralose or AceK) during 4 weeks on macrovascular endothelial function, in lean and obese subjects compared to placebo.
The principal outcome / endpoint will be based on flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected for shear rate, according to current recommendations, after 4 week of NNS (sucralose or AceK) daily consumption compared to placebo
CONDUCT OF THE RESEARCH : Patients will be screened and, if eligible, proposed a 3-period crossover trial (sucralose, AceK, placebo). The order will be randomized. These 3 periods will be separated with wash out periods between one and two weeks. The 3 periods of 4 weeks will be with one visit at the beginning and at the end of each period, i.e. a total of 6 visits. During each beginning and end of period visit, microvascular and macrovascular reactivity tests will be conducted. At the first visit only, microdialysis will be performed.
Number of subjects : 40 Length of the inclusion period: 24 months Length of treatment: 3 one-month periods, and maximum 4 weeks of wash-outs Length of participation for each subject: 4 months Total length of the study (with statistical analysis): 36 months
STATISTICAL ANALYSIS ; The analysis of the primary outcome will be carried on using an analysis of covariance (ANCOVA), adjusted on baseline FMD, with a risk alpha of 0.05 and a power of 80%, two-sided. Investogators estimated within-subject correlation to be close to 0.7, as shown in previous results by our group.5 In order to maximise power, for secondary objectives, the effects of sucralose, AceK, sex, and obesity, will be assessed using mixed-effects models, with the subject as a random factor.
EXPECTED IMPACT : This is a hot topic since recent studies in animals and humans do not support the claims previously submitted to regulatory agencies that NNS, including sucralose and AceK, are stable compounds that are not metabolized in vivo; and have no effect on metabolism. Questioning the physiological inactivity of these extensively used molecules is mandatory since there is a rise in the consumption of NNS-containing products. Moreover, very recent studies are observing an increase in the consumption of diet products, especially in vulnerable groups (obese, diabetic patients, children or pregnant women). New data on the effect of chronic NNS consumption will help revisit the regulatory status of NNS and bring extensive knowledge on the role of T1R receptors on vascular function, which has been hardly ever studied so far. Finally and importantly, vascular function is largely recognized as a strong precursor of cardiovascular disease.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Prospective, single-center, controlled, randomized, double-blind, three-period crossover study
| Arm | Type | Receives |
|---|---|---|
| subject with obesity | Experimental | Dietary Supplement: Non Nutritive Sweetenerscomposed of subject with obesity (Body mass index > 30) |
| lean subject | Experimental | Dietary Supplement: Non Nutritive Sweetenerscomposed of healthy volunteers (Body mass index < 30) |
Who may qualify
- Ages
- 18 to 100 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Male or female aged≥ 18 years
- Signed informed consent
- Body mass index:
- Person who is affiliated to a social security scheme or who is a beneficiary of such a scheme
Key exclusion criteria (6 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Non Nutritive SweetenersThe 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. | Dietary supplement | lean subject, subject with obesity |
Primary outcome
Macrovascular endothelial function
Time frame: through study completion, an average of 4 months
Flow-mediated dilation (FMD) of the brachial artery, expressed as a percent change from baseline diameter, and corrected for shear rate, according to current recommendations,6 after 4 week of NNS (sucralose or AceK) daily consumption compared to placebo.
28 secondary outcomes
Macrovascular non-endothelial function
Time frame: through study completion, an average of 4 months
Macrovascular endothelial function
Time frame: through study completion, an average of 4 months
Macrovascular non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial function
Time frame: through study completion, an average of 4 months
Microvascular non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial function
Time frame: through study completion, an average of 4 months
Microvascular non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Macrovascular endothelial function
Time frame: through study completion, an average of 4 months
Macrovascular non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial function
Time frame: through study completion, an average of 4 months
Microvascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolic function
Time frame: through study completion, an average of 4 months
Metabolomics profiles
Time frame: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Microvascular and macrovascular endothelial and non endothelial function
Time frame: through study completion, an average of 4 months
Microdialysis reactivity
Time frame: First visit, one day
Microdialysis reactivity
Time frame: First visit, one day
Microdialysis reactivity
Time frame: First visit, one day
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Dec 2023.
- Individual participant dataSharing planned: Yes. Data can be requested by contacting Prof. Roustit mroustit@chu-grenoble.fr
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Matthieu ROUSTIT, Pr principal investigator
Centre hospitalier universitaire grenoble alpes
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Non Nutritive Sweeteners in people with Non Nutritive Sweeteners Consumption, run by University Hospital, Grenoble at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 6 Dec 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Matthieu ROUSTIT, Pr (04 76 76 92 60, MRoustit@chu-grenoble.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Macrovascular endothelial function (time frame: through study completion, an average of 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Dec 2023.