Trial Outcomes & Findings for Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes (NCT NCT04385888)
NCT ID: NCT04385888
Last Updated: 2025-08-26
Results Overview
Change in Time in Range (TIR)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
62 participants
Primary outcome timeframe
Baseline vs Weeks 11-12
Results posted on
2025-08-26
Participant Flow
The reason that the number started does not equal the total enrollment is because there was a run-in period, prior to randomization, where 3 children (6 total participants including the child's parent) were lost to follow-up.
Participant milestones
| Measure |
Low-calorie Sweetener Restriction: Children
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.
Low-calorie sweetener restriction: 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
|
Usual Consumption/Control: Children
Participants will continue low-calorie sweetener consumption, as usual.
|
Low-calorie Sweetener Restriction: Parents
Participants will be instructed to have their child 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.
|
Usual Consumption/Control: Parents
Participants'children will continue low-calorie sweetener consumption, as usual.
|
|---|---|---|---|---|
|
Run-in Period
STARTED
|
16
|
15
|
16
|
15
|
|
Run-in Period
COMPLETED
|
15
|
13
|
15
|
13
|
|
Run-in Period
NOT COMPLETED
|
1
|
2
|
1
|
2
|
|
Randomized to Intervention or Control
STARTED
|
15
|
13
|
15
|
13
|
|
Randomized to Intervention or Control
COMPLETED
|
13
|
13
|
13
|
13
|
|
Randomized to Intervention or Control
NOT COMPLETED
|
2
|
0
|
2
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Effects of Low-calorie Sweetened Beverage Restriction in Youth With Type 1 Diabetes
Baseline characteristics by cohort
| Measure |
Low-calorie Sweetener Restriction: Children
n=15 Participants
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.
Low-calorie sweetener restriction: 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
|
Usual Consumption/Control: Children
n=13 Participants
Participants will continue low-calorie sweetener consumption, as usual.
|
Low-calorie Sweetener Restriction: Parents
Participants will be instructed to have their child 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.
|
Usual Consumption/Control: Parents
Participants' children will continue low-calorie sweetener consumption, as usual.
|
Total
n=28 Participants
Total of all reporting groups
|
|---|---|---|---|---|---|
|
Age, Continuous
|
9.7 years
STANDARD_DEVIATION 1.8 • n=5 Participants
|
9.7 years
STANDARD_DEVIATION 2.3 • n=7 Participants
|
—
|
—
|
9.7 years
STANDARD_DEVIATION 2.0 • n=21 Participants
|
|
Sex: Female, Male
Female
|
7 Participants
n=5 Participants
|
7 Participants
n=7 Participants
|
—
|
—
|
14 Participants
n=21 Participants
|
|
Sex: Female, Male
Male
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
—
|
14 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
14 Participants
n=5 Participants
|
12 Participants
n=7 Participants
|
—
|
—
|
26 Participants
n=21 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Black or African American
|
6 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
—
|
12 Participants
n=21 Participants
|
|
Race (NIH/OMB)
White
|
8 Participants
n=5 Participants
|
6 Participants
n=7 Participants
|
—
|
—
|
14 Participants
n=21 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
—
|
—
|
2 Participants
n=21 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
—
|
—
|
0 Participants
n=21 Participants
|
|
BMI percentile
|
62.1 percentile
STANDARD_DEVIATION 29.0 • n=5 Participants
|
73.9 percentile
STANDARD_DEVIATION 15.0 • n=7 Participants
|
—
|
—
|
67.6 percentile
STANDARD_DEVIATION 23.9 • n=21 Participants
|
|
Time since type 1 diabetes diagnosis
|
4.0 years
STANDARD_DEVIATION 2.9 • n=5 Participants
|
4.4 years
STANDARD_DEVIATION 2.1 • n=7 Participants
|
—
|
—
|
4.2 years
STANDARD_DEVIATION 2.5 • n=21 Participants
|
PRIMARY outcome
Timeframe: Baseline vs Weeks 11-12Population: The outcome was measured only among children who completed the study.
Change in Time in Range (TIR)
Outcome measures
| Measure |
Low-calorie Sweetener Restriction
n=13 Participants
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.
Low-calorie sweetener restriction: 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
|
Usual Consumption/Control
n=13 Participants
Participants will continue low-calorie sweetener consumption, as usual.
|
Low-calorie Sweetener Restriction: Parents
Participants will be instructed to have their child 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.
|
Usual Consumption/Control: Parents
Participants' children will continue low-calorie sweetener consumption, as usual.
|
|---|---|---|---|---|
|
Glycemic Variability
|
2.00 percent
Standard Deviation 2.59
|
3.91 percent
Standard Deviation 2.59
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline vs. Week 12Population: Outcomes were assessed for children, not parents
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.
Outcome measures
| Measure |
Low-calorie Sweetener Restriction
n=3 Participants
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.
Low-calorie sweetener restriction: 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
|
Usual Consumption/Control
n=5 Participants
Participants will continue low-calorie sweetener consumption, as usual.
|
Low-calorie Sweetener Restriction: Parents
Participants will be instructed to have their child 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.
|
Usual Consumption/Control: Parents
Participants' children will continue low-calorie sweetener consumption, as usual.
|
|---|---|---|---|---|
|
Visceral Adiposity
|
0.1 % body fat
Standard Error 1.1
|
1.0 % body fat
Standard Error 0.8
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline vs Week 12Population: The outcome was measured among children, not parents.
We will collect a blood sample to measure TNF-alpha and calculate the change from baseline.
Outcome measures
| Measure |
Low-calorie Sweetener Restriction
n=13 Participants
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.
Low-calorie sweetener restriction: 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
|
Usual Consumption/Control
n=13 Participants
Participants will continue low-calorie sweetener consumption, as usual.
|
Low-calorie Sweetener Restriction: Parents
Participants will be instructed to have their child 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.
|
Usual Consumption/Control: Parents
Participants' children will continue low-calorie sweetener consumption, as usual.
|
|---|---|---|---|---|
|
Change in Inflammatory Cytokines (TNF-alpha)
|
0.08 pg/mL
Standard Error 0.07
|
-0.23 pg/mL
Standard Error 0.08
|
—
|
—
|
Adverse Events
Low-calorie Sweetener Restriction: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Consumption/Control: Children
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Low-calorie Sweetener Restriction: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Usual Consumption/Control: Parents
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place