Sucralose and Glucose Metabolism in Young Healthy Adults (NCT07194772) | Clinical Trial Compass
CompletedNot Applicable
Sucralose and Glucose Metabolism in Young Healthy Adults
Canada42 participantsStarted 2022-03-16
Plain-language summary
This study aimed to investigate the effects of a three-week consumption of sucralose-sweetened beverages (low-calorie sweetener) on postprandial glycemic responses in healthy adults, compared with sugar-sweetened beverages under real-world conditions. In brief, postprandial glycemic responses are used as an indicator of how your body manages blood sugar levels after consuming glucose. To explore potential mechanisms underlying any observed changes in postprandial glycemic responses, we further investigated potential alterations in gut microbiota composition and functionality, as well as plasmatic biomarkers of intestinal permeability and systemic low-grade inflammation. Finally, this project explored whether free sugars derived from a natural source (100% natural fruit juice) elicit metabolic responses that differ from those of refined sugars.
Participants visited the laboratory for a preliminary screening session to assess eligibility prior to being randomly assigned to one of the three experimental groups consuming either sucralose-sweetened beverages (LCS), sucrose-sweetened beverages (SSB), or 100% natural fruit juice (FJ) at dosage approximating real-world consumption over three weeks. Participants underwent two experimental sessions (duration of 3 hours each) at the beginning and completion of the study as outlined below.
Who can participate
Age range
18 Years – 35 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
INCLUSION CRITERIA included :
* Ages 18-35 y
* Body mass index (BMI) between 18.0 and 34.9 kg/m2
* Waist circumference \< 102cm (men) and \< 88cm (women)
* Self-reported stable weight during the prior 6 months (+ or - 2kg) of beginning the study.
Additional Considerations related to the menstrual cycle and the use of hormonal contraceptives : All women who participated in this study were premenopausal. Recognizing the crucial importance of including women in our study while ensuring the highest quality data, additional considerations were applied to meet inclusion criteria:
* Women using no form of hormonal contraception or using copper intrauterine device (IUD) required to report having a regular menstrual cycle to be included
* Women using anovulants (birth control pills) were advised to take their daily anovulant continuously for a period of 28 days to ensure stable hormone levels throughout the study (informed consent was obtained). Oral contraceptives release a low and stable daily amount of progestins, which were reported to have minor or no effects on glycemic responses of pre-menopausal women in a recent meta-analysis (Silva-Bermudez 2020).
* Women using hormonal contraception such as hormonal IUD and subdermal contraceptive implant were included regardless of their menstrual cycle. Like anovulants, hormonal IUD release a low and stable amount of a progestin (levonorgestrel) into the uterus, therefore preventing periodic fluctuations in hormonal levels during the m…
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Change from Baseline in Postprandial Glycemic Responses