Status:
NOT_YET_RECRUITING
Resting-state Imaging and Chronic Consumption of Non-Nutritive SweetenerS
Lead Sponsor:
University Hospital, Clermont-Ferrand
Conditions:
Healthy Volunteers - Male and Female
Eligibility:
All Genders
18-30 years
Phase:
NA
Brief 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...
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 consumptio...
Eligibility Criteria
Inclusion
- 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
Exclusion
- 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
- 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.
Key Trial Info
Start Date :
October 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2027
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT07183254
Start Date
October 1 2025
End Date
December 1 2027
Last Update
September 19 2025
Active Locations (1)
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1
CHU Clermont-Ferrand
Clermont-Ferrand, France, 63000