Healthy Volunteers - Male and FemaleRNSSNCT07183254
Resting-state Imaging and Chronic Consumption of Non-Nutritive SweetenerS
A study testing administration of questionnaires, carrying out a MRI scan and Can distribution visit for subjects in the "non/low" sweetener consumption group in people with Healthy Volunteers - Male and Female, run by University Hospital, Clermont-Ferrand at 1 site in France.
Trial summary
Non-nutritive sweeteners are used as a substitute for simple sugars to improve the palatability of food products without increasing their sugar and calorie content. They represent a global market of 7 billion euros, with an annual growth of 5%. Reducing their consumption therefore seems to be excluded. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Volunteers - Male and Female
- What is being tested?
- administration of questionnaires, carrying out a MRI scan and Can distribution visit for subjects in the "non/low" sweetener consumption group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteFrance
- Study dates
- 1 Oct 2025to 1 Dec 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Men and women aged 18 to 30 (and in good health)
- Having low or no sweetener consumption (~8 mg ± 5.05 mg/day) or high consumption (~80 mg ± 91.72 mg/day)
- Having a BMI of 18.5 < 24.9
- For young women: having effective contraception maintained throughout the study
- Able to give informed consent to participate in the research
- Affiliation to a Social Security scheme
Who cannot join
- Refusing to participate in the research
- With impaired understanding, according to the investigator
- Volunteer under guardianship/curatorship/deprived of liberty or under legal protection
- Incompatibility of healthy volunteers with the medical imaging center's safety criteria for conducting 3 Tesla MRI experiments
- Presenting "contraindications" to an MRI examination without injection: presence of metal parts in the body (electronic devices such as a pacemaker, a neurostimulator, cochlear implant, prostheses, intraocular foreign bodies, etc.), claustrophobia, obesity
- Refusal to be informed in the event of an incidental discovery of an abnormality on MRI
Show all 21Show fewer
- Volunteer with neurological disease, psychiatric or behavioral disorders*
- Volunteer with addiction*:
- Nicotine: smoker or former smoker of less than 12 months;
- Alcoholism - "AUDIT" test: Female score ≥ 6 and male score ≥ 7;
- Drugs - "DAST-10": Score ≥ 1;
- Gambling - "ICJE": Score ≥ 3
- Video games - Modified DSM IV Video Game Addiction Test: More than 4 positive responses. - Positive urine drug screen
- Volunteer with an eating disorder (ED)*:
- o Eating disorder - "SCOFF": At least two positive responses. - Volunteers with at least one chronic condition (obesity, diabetes, cardiovascular, renal, or hepatic diseases, etc.)
- Pregnant or breastfeeding women, or healthy subjects wishing to conceive during the current study year*
- Any illness, health condition, or history deemed incompatible with the trial by the investigator
- Volunteers following a specific or highly restrictive diet (vegetarians, vegans, or vegans; multiple dietary exclusions related to religion, food allergies or intolerances; diets related to intensive exercise or weight-loss)*
- Currently excluded from another study
- Currently participating in another clinical trial, or in the exclusion period, or having received a total compensation amount exceeding €6,000 in the 12 months preceding the start of the trial,
- This study is part of a larger research project, also involving cognitive tasks and the measurement of food preferences. These exclusion criteria were therefore added in order to standardize the profile of the participants.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site
CHU Clermont-Ferrand
Clermont-Ferrand, 63000
Carine Chassain
Gisèle Pickering
About this study
Official title: Resting-state Functional Imaging in Chronic Consumption of Non-energetic Artificial Sweeteners
Non-nutritive sweeteners are used as a substitute for simple sugars to improve the palatability of food products without increasing their sugar and calorie content. They represent a global market of 7 billion euros, with an annual growth of 5%. Reducing their consumption therefore seems to be excluded. Some studies have focused on the impacts of these substances on brain activity. According to a recent study, continuous consumption of low doses of saccharin in adult mice significantly decreases the level of dopamine in the prefrontal cortex and significantly increases striatal dopamine, which modifies decision-making strategies. Resting-state functional Magnetic Resonance Imaging (r-fMRI) studies in humans have also shown that an increase in striatal dopaminergic activity modifies the resting-state functional connectivity of brain regions linked to the reward circuit. r-fMRI allows the characterization of brain networks and the strength of correlations between brain regions, without any specific task being required. It is a rapid, non-invasive technique that can measure changes in brain functional connectivity.
In addition to r-fMRI, diffusion tensor imaging (DTI) is able to assess white matter microstructure and the integrity or otherwise of fiber tracts. Several parameters such as the fractional anisotropy (FA), coefficient of white matter, mean diffusivity, and radial diffusivity can be modified in the event of changes in functional connectivity, reflecting axonal rearrangements, not visible on conventional MRI sequences. Based on previous research, investigators hypothesize that (1) chronic consumption of non-nutritive artificial sweeteners increases striatal dopaminergic activity. (2) This modification is accompanied by changes in resting-state functional connectivity in brain regions of interest associated with the reward circuit in healthy young adults.
Read more
Then, the primary objective of this study is to compare, in the resting state, the differences in functional connectivity of brain regions of interest between "non/low consumers" and "high consumers" of sweeteners at the start of the study using r-fMRI.
The key secondary objective of this study is to assess changes in brain connectivity using r-fMRI in non- and low-consuming subjects before and after a transient increase in their sweetener consumption over 5 weeks.
The secondary objectives include assessing daily sugar consumption (5-week follow-up), daily consumption of non-energy-rich artificial sweeteners (5-week follow-up), Body Mass Index (BMI), physical activity level, and white matter microstructure and fibrous tract integrity using a diffusion-weighted MRI (DTI) sequence.
Read the detailed description
A single-center interventional study in 35 non- and low-consumers (approximately 8 mg/day) and 35 high-consumers (approximately 70 mg/day) selected, among other things, using a quantitative consumption frequency questionnaire on daily sugar and sweetener intake, whose frequency scale has been validated by a previous study.
The subjects recruited are healthy young adults, aged 18 to 30 years. An initial f-rMRI and DTI session will be performed for both groups (non- and low-consumers and high-consumers of sweeteners).
Then, a second session will be conducted after 5 weeks of nutritional intervention only in non- and low-consumers of sweeteners. During this period, subjects will be asked to consume 660 ml of sweetened carbonated beverages, the equivalent of 2 cans per day, with or without meals. They will also be asked to record their daily sugar and sweetener consumption, using an adapted version of the previously mentioned consumption frequency questionnaire, during this same period.
The study will observe initial differences in brain connectivity between non- and low-consumers and high-consumers of sweeteners, as well as changes in connectivity in non- and low-consumers before and after the nutritional intervention.
Comparison of functional connectivity between non- and low consumers and high consumers, as well as the change in connectivity before and after nutritional intervention in non- and low consumers will be performed by comparing connectivity matrices among all possible pairs of regions of interest, with a t-test for independent samples (between non- and low consumers and high consumers at t = 0) and dependent samples (non- and low consumers pre- and post-nutrition intervention; t = 0 and t = 5 weeks). Results will be expressed in terms of effect sizes and 95% confidence intervals.
At baseline (t = 0), the assessment of daily intake of simple sugars and BMI, as well as the level of physical activity, will be analyzed in relation to the consumption of non-nutritive artificial sweeteners, using a one-way ANOVA or a Kruskal-Wallis test, and a Chi-square test or a Fisher's exact test, respectively.
The assessment of intakes of simple sugars and non-nutritive artificial sweeteners during the 5 weeks of nutritional intervention (t = 5 weeks) in non- and low-consumers will be compared to the intakes of sugars and sweeteners estimated at t = 0, using a dependent-samples t-test or a Mann-Whitney test, if the conditions for applying the t-test are not met. The results will be expressed in terms of effect size and 95% confidence interval. To describe changes in white matter microstructure in non- and low-drinkers compared with high-drinkers, anisotropic fraction and ADC will be compared by Student's t-test or Mann-Whitney test. Results will be expressed as effect sizes and 95% confidence intervals.
- Conditions
- Healthy Volunteers - Male and Female
- Being tested
- administration of questionnaires, carrying out a MRI scan, Can distribution visit for subjects in the "non/low" sweetener consumption group
- Keywords
- non-nutritive sweeteners, non- and low consumers, high consumers, resting-state MRI, diffusion tensor imaging (DTI), reward circuit, resting-state functional connectivity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
administration of questionnairesOther
Also called Visit 1
During this visit, the investigator will again explain the study objectives and procedure. Once these explanations have been provided, healthy volunteers will be able to give their informed consent to participate.
After signing the consent form, the following will be conducted during this visit:
- A medical examination.
- An electronic questionnaire including two consumption frequency assessment tools, adapted in French, to measure daily sugar and artificial sweetener intake.
- Five tests assess the level of dependence on alcohol, drugs (cannabis, solvents, tranquilizers, barbiturates, cocaine, stimulants, hallucinogens, or narcotics), gambling, video games, and possible eating disorders. Volunteers with a score deemed above the norm for at least one of these six tests will be excluded from this study.
- A urine screening test for drug use (cannabis, opiates, amphetamines, cannabinoids, benzodiazepines, cocaine) will be performed during this visit.
carrying out a MRI scanOther
Also called Visit 2 - Resting-state fMRI and DTI - Department of Radiology and Imaging
A functional exploration using resting-state fMRI and microstructural tissue organization using DTI will take place in the days following the inclusion visit, depending on the availability of "research" slots in the Department of Radiology and Imaging, Clermont-Ferrand University Hospital.
Can distribution visit for subjects in the "non/low" sweetener consumption groupDietary supplement
Also called Visit 3
During this visit, scheduled following the MRI, subjects will go to the PIC/CIC where they will be given cans for the 5 weeks of the nutritional intervention (660 ml of sweetened beverage, or 2 cans per day). Subjects will be advised to arrive by car if possible and to park in the PIC/CIC parking lot at the foot of the building. Drinks will be provided to the subject in one or two batches (with an additional visit to the center to pick up any missing drinks) at the subject's convenience. They will also receive instructions for completing the electronic questionnaire to assess daily sugar and sweetener consumption. Subjects will complete this questionnaire weekly, which they will receive by email. Their email address will be collected during this visit.
carrying out a MRI scanOther
Also called Visit 4
A functional exploration using resting-state fMRI and microstructural tissue organization using DTI, post-nutritional intervention (5 weeks) in non- and low-sugar consumers: this exploration will take place depending on the availability of "research" slots at the Department of Radiology and Imaging, Clermont-Ferrand University Hospital.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 | Experimental | Subjects will be included:
* Men and women aged 18 to 30 (and in good health)
* Having low or no sweetener consumption (~8 mg ± 5.05 mg/day)
* Having a BMI of 18.5 < 24.9
* For young women: having effective contraception maintained throughout the study
* Able to give informed consent to participate in the research
* Affiliation to a Social Security scheme Receives: Other: administration of questionnaires; Other: carrying out a MRI scan; Dietary Supplement: Can distribution visit for subjects in the "non/low" sweetener consumption group |
| Subjects with high sweetener consumption, with a gender ratio close to 50/50 | Experimental | Subjects will be included:
* Men and women aged 18 to 30 (and in good health)
* Having high sweetener consumption (~80 mg ± 91.72 mg/day)
* Having a BMI of 18.5 < 24.9
* For young women: having effective contraception maintained throughout the study
* Able to give informed consent to participate in the research
* Affiliation to a Social Security scheme Receives: Other: administration of questionnaires; Other: carrying out a MRI scan |
What is being measured
The primary outcome is the main question the study is designed to answer.
1. At rest, functional connectivity between brain areas in healthy subjects, non/low consumers and high consumers of sweetener
Resting-state functional magnetic resonance imaging (rs-fMRI) is a method that studies the connectivity of different regions of the nervous system. Based on the acquisition of the BOLD (Bond Oxygen Level Dependent) signal, this method focuses more specifically on the study of low-frequency fluctuations (<0.1 Hz) of this signal. The goal of resting-state imaging is to identify the synchronous activation of different regions of the brain and brainstem, in the absence of a stimulus or a task being performed. This activation can be observed between physically connected regions, or not, and demonstrates the involvement of these regions in a common network called the "Resting State Network" (RSN), which brings together different brain regions involved in common functions; this is referred to as "functional connectivity" between these regions. Areas of interest involved in the reward circuit (amygdala, nucleus accumbens, anterior insula, striatum, the prefrontal cortex, hypothalamus).
Measured: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
Secondary outcomes (8)
Functional connectivity, at rest, before and after nutritional intervention in non- and low-sugar consumers (criterion for the key secondary objective).
rs-fMRI
Measured: Immediately after completion of the 5-weeks nutritional intervention.
The amount of sugar consumed per day during the 5 weeks of nutritional intervention in non- and low-sugar consumers (mg/day).
Non-Nutritive Sweetener Food Frequency Questionnaire
Measured: Daily during the 5 weeks of the nutritional intervention among non-users and low consumers of sweeteners.
The amount of artificial sweeteners consumed per day during the 5 weeks of nutritional intervention in non- and low-sugar consumers. (mg/day).
Non-Nutritive Sweetener Food Frequency Questionnaire
Measured: Daily during the 5 weeks of nutritional intervention in non- and low-sugar consumers.
Body Mass Index (BMI)
Body mass index (BMI) is a medical screening tool that measures the ratio of your height to your weight to estimate the amount of body fat you have. Healthcare providers calculate BMI by using weight in kilograms (kg) divided by the square of height in meters (m2). Healthy BMI range: 18.5 - 24.9
Measured: At enrollment
Level of physical activity (number of hours of exercise per week).
Questionnaire.
Physical activity will be categorized based on the number of hours of exercise per week as follows:
- Low (< 2 hours/week)
- Moderate (2-4 hours/week)
- High (> 4 hours/week
Measured: At enrollment
The various tractography parameter characterizing the microstructure of the white matter: FA (fractional anisotropy), in brain regions in reward system.
A medical image analysis platform (https://www.olea-medical.com/fr/solutions) is used for the analysis of diffusion tensor imaging (DTI) MRI sequence data. DTI parameters were measured from regions of interest (ROI) on brain structures involved in the reward circuit include, among others, the amygdala, the nucleus accumbens, the anterior insula, the striatum, the prefrontal cortex, and the hypothalamus.
FA is a normalized scalar index ranging between 0 (completely isotropic diffusion, equal in all directions, e.g., cerebrospinal fluid) and 1(highly anisotropic diffusion, in a single direction, e.g., intact and well-aligned axons).
Measured: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
The various tractography parameters characterizing the microstructure of the white matter: diffusion parameters (axial and radial diffusion) in brain regions in reward system.
A medical image analysis platform (https://www.olea-medical.com/fr/solutions) is used for the analysis of diffusion tensor imaging (DTI) MRI sequence data. DTI parameters were measured from regions of interest (ROI) on brain structures involved in the reward circuit include, among others, the amygdala, the nucleus accumbens, the anterior insula, the striatum, the prefrontal cortex, and the hypothalamus.
Mean diffusivity (MD), Axial diffusivity (AD, diffusion along the principal axis of the nerve fibers) and radial diffusivity (RD, diffusion across the principal axis of the nerve fibers) in diffusion tensor imaging (DTI) are expressed in mm²/s, often reported as ×10-³ mm²/s.
In normal white matter, MD is around 0.7-0.9 ×10-³ mm²/s, AD is approximately 1.1-1.3 ×10-³ mm²/s and RD is approximately 0.6-0.8 ×10-³ mm²/s.
Measured: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
The various tractography parameter characterizing the microstructure of the white matter: ADC (apparent diffusion coefficient) in brain regions in reward system.
A medical image analysis platform (https://www.olea-medical.com/fr/solutions) is used for the analysis of diffusion tensor imaging (DTI) MRI sequence data. DTI parameters were measured from regions of interest (ROI) on brain structures involved in the reward circuit include, among others, the amygdala, the nucleus accumbens, the anterior insula, the striatum, the prefrontal cortex, and the hypothalamus.
The ADC reflects the mean diffusivity of water within a voxel, accounting for both Brownian motion and tissue microstructural properties. It is reported in ×10-³ mm²/s, with normal values of ~0.7-0.9 in white matter, ~0.8-1.0 in gray matter, and ~3.0 in cerebrospinal fluid.
Measured: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Sep 2025
- Study start1 Oct 2025 (estimated)
- Primary completion1 Dec 2026 (estimated)
- Study completion1 Dec 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy Volunteers - Male and FemaleStudies of the same condition, open and under way.
- More trials run by University Hospital, Clermont-FerrandThe 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
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Two Groups: * Healthy subjects, both low and non-sweetener consumers (\~ 8 mg ± 5,05 mg / day), will have to consume 660 ml of sweetened beverage (2 cans) per day, which corresponds to an estimate of more than 87 mg of a mixture of acesulfame K and aspartame, for 5 weeks. * Healthy subjects, high sweetener consumers (\~80 mg ± 91,72 mg / day)
- Masking
- None (open label)
- Enrolment
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Clermont-Ferrand
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Gisèle Pickering, Principal investigator, University Hospital, Clermont-Ferrand
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07183254
- Sponsor's protocol ID
- RBHP 2025 PICKERING
- Acronym
- RNSS
- Status last verified
- Sep 2025
- First submitted
- 8 Sep 2025
- Last updated
- 19 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Resting-state Functional Imaging in Chronic Consumption of Non-energetic Artificial Sweeteners
- ClinicalTrials.gov ID
- NCT07183254
- Acronym / sponsor ID
- RNSS / RBHP 2025 PICKERING
- Conditions
- Healthy Volunteers - Male and Female
- Keywords
- non-nutritive sweeteners, non- and low consumers, high consumers, resting-state MRI, diffusion tensor imaging (DTI), reward circuit, resting-state functional connectivity
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- University Hospital, Clermont-FerrandUniversity, hospital or other
- Study start
- 1 Oct 2025 (estimated)
- Primary completion
- 1 Dec 2026 (estimated)
- Study completion
- 1 Dec 2027 (estimated)
- First posted
- 19 Sep 2025 (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.
Non-nutritive sweeteners are used as a substitute for simple sugars to improve the palatability of food products without increasing their sugar and calorie content. They represent a global market of 7 billion euros, with an annual growth of 5%. Reducing their consumption therefore seems to be excluded. Some studies have focused on the impacts of these substances on brain activity. According to a recent study, continuous consumption of low doses of saccharin in adult mice significantly decreases the level of dopamine in the prefrontal cortex and significantly increases striatal dopamine, which modifies decision-making strategies. Resting-state functional Magnetic Resonance Imaging (r-fMRI) studies in humans have also shown that an increase in striatal dopaminergic activity modifies the resting-state functional connectivity of brain regions linked to the reward circuit. r-fMRI allows the characterization of brain networks and the strength of correlations between brain regions, without any specific task being required. It is a rapid, non-invasive technique that can measure changes in brain functional connectivity.
In addition to r-fMRI, diffusion tensor imaging (DTI) is able to assess white matter microstructure and the integrity or otherwise of fiber tracts. Several parameters such as the fractional anisotropy (FA), coefficient of white matter, mean diffusivity, and radial diffusivity can be modified in the event of changes in functional connectivity, reflecting axonal rearrangements, not visible on conventional MRI sequences. Based on previous research, investigators hypothesize that (1) chronic consumption of non-nutritive artificial sweeteners increases striatal dopaminergic activity. (2) This modification is accompanied by changes in resting-state functional connectivity in brain regions of interest associated with the reward circuit in healthy young adults.
Then, the primary objective of this study is to compare, in the resting state, the differences in functional connectivity of brain regions of interest between "non/low consumers" and "high consumers" of sweeteners at the start of the study using r-fMRI.
The key secondary objective of this study is to assess changes in brain connectivity using r-fMRI in non- and low-consuming subjects before and after a transient increase in their sweetener consumption over 5 weeks.
The secondary objectives include assessing daily sugar consumption (5-week follow-up), daily consumption of non-energy-rich artificial sweeteners (5-week follow-up), Body Mass Index (BMI), physical activity level, and white matter microstructure and fibrous tract integrity using a diffusion-weighted MRI (DTI) sequence.
Detailed description
A single-center interventional study in 35 non- and low-consumers (approximately 8 mg/day) and 35 high-consumers (approximately 70 mg/day) selected, among other things, using a quantitative consumption frequency questionnaire on daily sugar and sweetener intake, whose frequency scale has been validated by a previous study.
The subjects recruited are healthy young adults, aged 18 to 30 years. An initial f-rMRI and DTI session will be performed for both groups (non- and low-consumers and high-consumers of sweeteners).
Then, a second session will be conducted after 5 weeks of nutritional intervention only in non- and low-consumers of sweeteners. During this period, subjects will be asked to consume 660 ml of sweetened carbonated beverages, the equivalent of 2 cans per day, with or without meals. They will also be asked to record their daily sugar and sweetener consumption, using an adapted version of the previously mentioned consumption frequency questionnaire, during this same period.
The study will observe initial differences in brain connectivity between non- and low-consumers and high-consumers of sweeteners, as well as changes in connectivity in non- and low-consumers before and after the nutritional intervention.
Comparison of functional connectivity between non- and low consumers and high consumers, as well as the change in connectivity before and after nutritional intervention in non- and low consumers will be performed by comparing connectivity matrices among all possible pairs of regions of interest, with a t-test for independent samples (between non- and low consumers and high consumers at t = 0) and dependent samples (non- and low consumers pre- and post-nutrition intervention; t = 0 and t = 5 weeks). Results will be expressed in terms of effect sizes and 95% confidence intervals.
At baseline (t = 0), the assessment of daily intake of simple sugars and BMI, as well as the level of physical activity, will be analyzed in relation to the consumption of non-nutritive artificial sweeteners, using a one-way ANOVA or a Kruskal-Wallis test, and a Chi-square test or a Fisher's exact test, respectively.
The assessment of intakes of simple sugars and non-nutritive artificial sweeteners during the 5 weeks of nutritional intervention (t = 5 weeks) in non- and low-consumers will be compared to the intakes of sugars and sweeteners estimated at t = 0, using a dependent-samples t-test or a Mann-Whitney test, if the conditions for applying the t-test are not met. The results will be expressed in terms of effect size and 95% confidence interval. To describe changes in white matter microstructure in non- and low-drinkers compared with high-drinkers, anisotropic fraction and ADC will be compared by Student's t-test or Mann-Whitney test. Results will be expressed as effect sizes and 95% confidence intervals.
Study design
- Primary purpose
- Basic science
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Two Groups: * Healthy subjects, both low and non-sweetener consumers (~ 8 mg ± 5,05 mg / day), will have to consume 660 ml of sweetened beverage (2 cans) per day, which corresponds to an estimate of more than 87 mg of a mixture of acesulfame K and aspartame, for 5 weeks. * Healthy subjects, high sweetener consumers (~80 mg ± 91,72 mg / day)
| Arm | Type | Receives |
|---|---|---|
| Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 | Experimental | Other: administration of questionnaires, Other: carrying out a MRI scan, Dietary Supplement: Can distribution visit for subjects in the "non/low" sweetener consumption groupSubjects will be included: * Men and women aged 18 to 30 (and in good health) * Having low or no sweetener consumption (~8 mg ± 5.05 mg/day) * Having a BMI of 18.5 < 24.9 * For young women: having effective contraception maintained throughout the study * Able to give informed consent to participate in the research * Affiliation to a Social Security scheme |
| Subjects with high sweetener consumption, with a gender ratio close to 50/50 | Experimental | Other: administration of questionnaires, Other: carrying out a MRI scanSubjects will be included: * Men and women aged 18 to 30 (and in good health) * Having high sweetener consumption (~80 mg ± 91.72 mg/day) * Having a BMI of 18.5 < 24.9 * For young women: having effective contraception maintained throughout the study * Able to give informed consent to participate in the research * Affiliation to a Social Security scheme |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Men and women aged 18 to 30 (and in good health)
- Having low or no sweetener consumption (~8 mg ± 5.05 mg/day) or high consumption (~80 mg ± 91.72 mg/day)
- Having a BMI of 18.5 < 24.9
- For young women: having effective contraception maintained throughout the study
- Able to give informed consent to participate in the research
Key exclusion criteria (21 listed)
- Refusing to participate in the research
- With impaired understanding, according to the investigator
- Volunteer under guardianship/curatorship/deprived of liberty or under legal protection
- Incompatibility of healthy volunteers with the medical imaging center's safety criteria for conducting 3 Tesla MRI experiments
- Presenting "contraindications" to an MRI examination without injection: presence of metal parts in the body (electronic devices such as a pacemaker, a neurostimulator, cochlear implant, prostheses, intraocular foreign bodies, etc.), claustrophobia, obesity
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 |
|---|---|---|
| administration of questionnairesAlso: Visit 1During this visit, the investigator will again explain the study objectives and procedure. Once these explanations have been provided, healthy volunteers will be able to give their informed consent to participate. After signing the consent form, the following will be conducted during this visit: * A medical examination. * An electronic questionnaire including two consumption frequency assessment tools, adapted in French, to measure daily sugar and artificial sweetener intake. * Five tests assess the level of dependence on alcohol, drugs (cannabis, solvents, tranquilizers, barbiturates, cocaine, stimulants, hallucinogens, or narcotics), gambling, video games, and possible eating disorders. Volunteers with a score deemed above the norm for at least one of these six tests will be excluded from this study. * A urine screening test for drug use (cannabis, opiates, amphetamines, cannabinoids, benzodiazepines, cocaine) will be performed during this visit. | Other | Subjects with high sweetener consumption, with a gender ratio close to 50/50, Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 |
| carrying out a MRI scanAlso: Visit 2 - Resting-state fMRI and DTI - Department of Radiology and ImagingA functional exploration using resting-state fMRI and microstructural tissue organization using DTI will take place in the days following the inclusion visit, depending on the availability of "research" slots in the Department of Radiology and Imaging, Clermont-Ferrand University Hospital. | Other | Subjects with high sweetener consumption, with a gender ratio close to 50/50, Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 |
| Can distribution visit for subjects in the "non/low" sweetener consumption groupAlso: Visit 3During this visit, scheduled following the MRI, subjects will go to the PIC/CIC where they will be given cans for the 5 weeks of the nutritional intervention (660 ml of sweetened beverage, or 2 cans per day). Subjects will be advised to arrive by car if possible and to park in the PIC/CIC parking lot at the foot of the building. Drinks will be provided to the subject in one or two batches (with an additional visit to the center to pick up any missing drinks) at the subject's convenience. They will also receive instructions for completing the electronic questionnaire to assess daily sugar and sweetener consumption. Subjects will complete this questionnaire weekly, which they will receive by email. Their email address will be collected during this visit. | Dietary supplement | Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 |
| carrying out a MRI scanAlso: Visit 4A functional exploration using resting-state fMRI and microstructural tissue organization using DTI, post-nutritional intervention (5 weeks) in non- and low-sugar consumers: this exploration will take place depending on the availability of "research" slots at the Department of Radiology and Imaging, Clermont-Ferrand University Hospital. | Other | Subjects with low or no sweetener consumption, with a gender ratio close to 50/50 |
Primary outcome
1. At rest, functional connectivity between brain areas in healthy subjects, non/low consumers and high consumers of sweetener
Time frame: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
Resting-state functional magnetic resonance imaging (rs-fMRI) is a method that studies the connectivity of different regions of the nervous system. Based on the acquisition of the BOLD (Bond Oxygen Level Dependent) signal, this method focuses more specifically on the study of low-frequency fluctuations (<0.1 Hz) of this signal. The goal of resting-state imaging is to identify the synchronous activation of different regions of the brain and brainstem, in the absence of a stimulus or a task being performed. This activation can be observed between physically connected regions, or not, and demonstrates the involvement of these regions in a common network called the "Resting State Network" (RSN), which brings together different brain regions involved in common functions; this is referred to as "functional connectivity" between these regions. Areas of interest involved in the reward circuit (amygdala, nucleus accumbens, anterior insula, striatum, the prefrontal cortex, hypothalamus).
8 secondary outcomes
Functional connectivity, at rest, before and after nutritional intervention in non- and low-sugar consumers (criterion for the key secondary objective).
Time frame: Immediately after completion of the 5-weeks nutritional intervention.
The amount of sugar consumed per day during the 5 weeks of nutritional intervention in non- and low-sugar consumers (mg/day).
Time frame: Daily during the 5 weeks of the nutritional intervention among non-users and low consumers of sweeteners.
The amount of artificial sweeteners consumed per day during the 5 weeks of nutritional intervention in non- and low-sugar consumers. (mg/day).
Time frame: Daily during the 5 weeks of nutritional intervention in non- and low-sugar consumers.
Body Mass Index (BMI)
Time frame: At enrollment
Level of physical activity (number of hours of exercise per week).
Time frame: At enrollment
The various tractography parameter characterizing the microstructure of the white matter: FA (fractional anisotropy), in brain regions in reward system.
Time frame: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
The various tractography parameters characterizing the microstructure of the white matter: diffusion parameters (axial and radial diffusion) in brain regions in reward system.
Time frame: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
The various tractography parameter characterizing the microstructure of the white matter: ADC (apparent diffusion coefficient) in brain regions in reward system.
Time frame: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Sep 2025.
- Individual participant dataSharing planned: No
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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.
Gisèle Pickering principal investigator
University Hospital, Clermont-Ferrand
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing administration of questionnaires, carrying out a MRI scan and Can distribution visit for subjects in the "non/low" sweetener consumption group in people with Healthy Volunteers - Male and Female, run by University Hospital, Clermont-Ferrand 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 21 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: opening soon, as of the sponsor's last update on 19 Sep 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lise Laclautre (+334.73.754.963, promo_interne_drci@chu-clermontferrand.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
1. At rest, functional connectivity between brain areas in healthy subjects, non/low consumers and high consumers of sweetener (time frame: High sweetner consumers: within 4 weeks after enrollment. Low or no sweetner consumer: within 4 weeks after enrollment and immediately after completion of the 5-weeks nutritional intervention.). 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 19 Sep 2025.