An interventional study of Low-calorie sweetener restriction in Type 1 Diabetes, sponsored by Allison Sylvetsky (Meni). Completed at 1 site in United States. Open to participants aged 6 Years to 12 Years. Per ClinicalTrials.gov, last updated 2025-08-26.
Sponsored by Allison Sylvetsky (Meni) · Not applicable, Interventional, and Other
This study will investigate whether low-calorie sweeteners (LCS) are helpful or harmful for preventing diabetes complications among children with Type 1 Diabetes (T1D).
Eligible participants will be scheduled for a baseline visit. During the week prior, they will be instructed to continue usual dietary habits and complete an online photo-assisted food record, with parental assistance. At the baseline visit, height and weight will be measured, a spot urine sample will be collected, and a blood draw will be performed. Participants will have their CGM data for the past two weeks downloaded. In a subset of participants, an abdominal MRI will also be performed.
Subjects will then be randomized to either: 1) low-calorie sweetener (LCS) restriction or 2) continuation of usual LCS intake (control). All participants (both groups) and their parent will undergo a brief, 20-minute orientation where the PI and study dietitian will provide an introduction to the study, instructions on completing food records, education on CGM. Those in the intervention group will be given sample replacement beverages and a brochure on avoiding LCS to take home which will include a list of specific foods and beverages containing LCS to avoid during the study. Participants in the control group will be counseled on healthy eating as those in the intervention group (in accordance with standard dietary guidance for T1D management), with the exception of information and resources for avoiding LCS.
In both groups, text messages will be sent to parents 3X/week with reminders that their child should avoid LCS or continue usual intake, per randomization. Adherence will be monitored through collection of spot-urine samples for measurement of sucralose and ace-K concentrations. daily text message beverage logs completed by the parent, and photo-assisted food records with parent assistance in Weeks 0, 1, 6, and 12. During Week 6, participants and their parent will attend a mid-intervention telemedicine booster visit, during which the PI and/or study RA will reinforce the intervention and remind participants to mail back a spot urine sample using materials provided by the study team at baseline. Participants will be reminded of the study instructions, including the importance of inserting the DEXCOM G6 sensor (provided by study team) at the beginning of Week 11.
At the end of Week 12, participants and their parent will return for follow-up. Participants will have their CGM data downloaded using DEXCOM Clarity™ software. Height and weight will be measured and a second blood draw performed. Those who had an MRI at the baseline visit (n=30) will undergo a second abdominal MRI. Those randomized to the intervention will be purposefully sampled and asked to complete a \~20 minute qualitative interview and \~5 minute satisfaction survey, together with their parent, about their study experience and the challenges of LCSB restriction.
3,522 studies on the registry are indexed under Diabetes Mellitus, Type 1; 577 are open to participants now.
This study's enrollment of 62 is above the median of 40 across 2,649 interventional studies indexed under Diabetes Mellitus, Type 1.
Browse Diabetes Mellitus, Type 1 studies →This is the only study on the registry with Allison Sylvetsky (Meni) as lead sponsor.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Participants will be instructed to avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners, and to instead consume unsweetened alternatives, such as plain or sparkling water for 12 weeks.
Behavioral: Low-calorie sweetener restriction
Participants will continue low-calorie sweetener consumption, as usual.
Participants will avoid low-calorie sweetened beverages and other sources of low-calorie sweeteners for 12 weeks and will instead consume unsweetened alternatives, such as still or sparkling water
Glycemic Variability
Change in Time in Range (TIR)
Time frame: Baseline vs Weeks 11-12
Visceral Adiposity
Change in visceral fat area will be assessed using DXA. Due to COVID-19, very few participants were able to have visceral fat measured pre and post intervention.
Time frame: Baseline vs. Week 12
Change in Inflammatory Cytokines (TNF-alpha)
We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.
Time frame: Baseline vs Week 12
| Milestone | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents |
|---|---|---|---|---|
| Started | 16 | 15 | 16 | 15 |
| Completed | 15 | 13 | 15 | 13 |
| Not completed | 1 | 2 | 1 | 2 |
| Milestone | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents |
|---|---|---|---|---|
| Started | 15 | 13 | 15 | 13 |
| Completed | 13 | 13 | 13 | 13 |
| Not completed | 2 | 0 | 2 | 0 |
Change in Time in Range (TIR)
| percent | Low-calorie Sweetener Restriction | Usual Consumption/Control | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents |
|---|---|---|---|---|
| Glycemic Variability | 2.00 ± 2.59 | 3.91 ± 2.59 | — | — |
Change in visceral fat area will be assessed using DXA. Due to COVID-19, very few participants were able to have visceral fat measured pre and post intervention.
| % body fat | Low-calorie Sweetener Restriction | Usual Consumption/Control | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents |
|---|---|---|---|---|
| Visceral Adiposity | 0.1 ± 1.1 | 1.0 ± 0.8 | — | — |
We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.
| pg/mL | Low-calorie Sweetener Restriction | Usual Consumption/Control | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents |
|---|---|---|---|---|
| Change in Inflammatory Cytokines (TNF-alpha) | 0.08 ± 0.07 | -0.23 ± 0.08 | — | — |
Collected over Adverse event data were collected for each participant during the 14 weeks they were enrolled in the study.. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Low-calorie Sweetener Restriction: Children | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Usual Consumption/Control: Children | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Low-calorie Sweetener Restriction: Parents | 0/15 (0%) | 0/15 (0%) | 0/15 (0%) |
| Usual Consumption/Control: Parents | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
Baseline characteristics were not collected for parents.
| Age, Continuous(years) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| Mean | 9.7 ± 1.8 | 9.7 ± 2.3 | — | — | 9.7 ± 2.0 |
| Sex: Female, Male(Participants) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| Female | 7 | 7 | — | — | 14 |
| Male | 8 | 6 | — | — | 14 |
| Ethnicity (NIH/OMB)(Participants) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| Hispanic or Latino | 1 | 1 | — | — | 2 |
| Not Hispanic or Latino | 14 | 12 | — | — | 26 |
| Unknown or Not Reported | 0 | 0 | — | — | 0 |
| Race (NIH/OMB)(Participants) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| American Indian or Alaska Native | 0 | 0 | — | — | 0 |
| Asian | 0 | 0 | — | — | 0 |
| Native Hawaiian or Other Pacific Islander | 0 | 0 | — | — | 0 |
| Black or African American | 6 | 6 | — | — | 12 |
| White | 8 | 6 | — | — | 14 |
| More than one race | 1 | 1 | — | — | 2 |
| Unknown or Not Reported | 0 | 0 | — | — | 0 |
| BMI percentile(percentile) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| Mean | 62.1 ± 29.0 | 73.9 ± 15.0 | — | — | 67.6 ± 23.9 |
| Time since type 1 diabetes diagnosis(years) | Low-calorie Sweetener Restriction: Children | Usual Consumption/Control: Children | Low-calorie Sweetener Restriction: Parents | Usual Consumption/Control: Parents | Total |
|---|---|---|---|---|---|
| Mean | 4.0 ± 2.9 | 4.4 ± 2.1 | — | — | 4.2 ± 2.5 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
This study is completed, as verified in Aug 2025. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.