Trial Outcomes & Findings for Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes (NCT NCT03944616)

NCT ID: NCT03944616

Last Updated: 2025-09-11

Results Overview

Glycated hemoglobin

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 181 participants
• Primary outcome timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks
• Results posted on: 2025-09-11

Participant Flow

Participant milestones

Measure	Diet Beverage Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Overall Study STARTED	91	90
Overall Study COMPLETED	91	88
Overall Study NOT COMPLETED	0	2

Reasons for withdrawal

Measure	Diet Beverage Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Overall Study Lost to Follow-up	0	2

Baseline Characteristics

Study Of Drinks With Artificial Sweeteners in People With Type 2 Diabetes

Baseline characteristics by cohort

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.	Total n=181 Participants Total of all reporting groups
Age, Continuous	59.6 years STANDARD_DEVIATION 10.4 • n=5 Participants	60.7 years STANDARD_DEVIATION 10.1 • n=7 Participants	60.1 years STANDARD_DEVIATION 10.2 • n=5 Participants
Sex: Female, Male Female	47 Participants n=5 Participants	47 Participants n=7 Participants	94 Participants n=5 Participants
Sex: Female, Male Male	44 Participants n=5 Participants	43 Participants n=7 Participants	87 Participants n=5 Participants
Race/Ethnicity, Customized African American or Black	4 Participants n=5 Participants	2 Participants n=7 Participants	6 Participants n=5 Participants
Race/Ethnicity, Customized Hispanic/Latino(a)	9 Participants n=5 Participants	11 Participants n=7 Participants	20 Participants n=5 Participants
Race/Ethnicity, Customized White (non-Hispanic)	68 Participants n=5 Participants	67 Participants n=7 Participants	135 Participants n=5 Participants
Race/Ethnicity, Customized Other	10 Participants n=5 Participants	10 Participants n=7 Participants	20 Participants n=5 Participants
Region of Enrollment United States	91 participants n=5 Participants	90 participants n=7 Participants	181 participants n=5 Participants

PRIMARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Participants analyzed at each time point equals: baseline (all those randomized to arm), 12 weeks (reflects those who were not able to participate in visit with blood draw to to Covid-19 restrictions and dropouts), and 24 weeks (all ASB participants provided data, 87 water participants (2 dropouts/lost to follow up and 1 with sample not able to be analyzed)

Glycated hemoglobin

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
HbA1c Time 0	7.19 Hba1c(%) Standard Deviation 1.10	7.20 Hba1c(%) Standard Deviation 0.69
HbA1c 12 weeks	7.13 Hba1c(%) Standard Deviation 1.02	7.43 Hba1c(%) Standard Deviation 1.02
HbA1c 24 weeks	7.14 Hba1c(%) Standard Deviation 1.19	7.44 Hba1c(%) Standard Deviation 1.04

SECONDARY outcome

Timeframe: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline

Time in range is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Time in Range is defined as the % of time each day with a glucose measure between 70-180 mg/dl. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

Outcome measures

Measure	Diet Beverage n=88 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=87 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Time In Range Baseline	76.0 % Time in Range Standard Deviation 19.2	72.3 % Time in Range Standard Deviation 20.9
Time In Range Week 11-12	75.2 % Time in Range Standard Deviation 22.6	66.9 % Time in Range Standard Deviation 26.2
Time In Range Week 23-24	72.8 % Time in Range Standard Deviation 23.2	64.7 % Time in Range Standard Deviation 26.5

SECONDARY outcome

Timeframe: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline

Glycemic variability is collected by a masked Continuous Glucose Monitor (CGM), which measures individual glucose levels every 15 minutes for two weeks via a sensor placed on the participants upper arm (underside). Glycemic variability is defined as the Standard Deviation (SD) of the mean glucose during the wear period. The range of CGM data for inclusion in this study will be 5 to 14 days, consistent with manufacturer's recommendations.

Outcome measures

Measure	Diet Beverage n=88 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=87 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Glycemic Variability Baseline	39.6 SD of mean glucose (mg/dl) Standard Deviation 14.7	42.0 SD of mean glucose (mg/dl) Standard Deviation 13.1
Glycemic Variability Weeks 11-12	40.0 SD of mean glucose (mg/dl) Standard Deviation 12.9	44.9 SD of mean glucose (mg/dl) Standard Deviation 15.4
Glycemic Variability Weeks 23-24	40.8 SD of mean glucose (mg/dl) Standard Deviation 14.9	45.8 SD of mean glucose (mg/dl) Standard Deviation 16.3

SECONDARY outcome

Timeframe: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)

Population: Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline

A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period

Outcome measures

Measure	Diet Beverage n=88 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=87 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Mean Glucose (mg/dl) Baseline	147.3 mg/dl Standard Deviation 42.1	151.4 mg/dl Standard Deviation 33.1
Mean Glucose (mg/dl) Weeks 11-12	149.4 mg/dl Standard Deviation 46.4	161.2 mg/dl Standard Deviation 50.5
Mean Glucose (mg/dl) Weeks 23-24	153.1 mg/dl Standard Deviation 50.7	162.3 mg/dl Standard Deviation 47.3

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to invalid lab sample, COVID-19 restrictions, and 2 participants who withdrew after baseline

Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks

Outcome measures

Measure	Diet Beverage n=90 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=88 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Fasting Glucose Baseline	147.5 mg/dl Standard Deviation 40.0	147.6 mg/dl Standard Deviation 36.2
Fasting Glucose Week 12	146.2 mg/dl Standard Deviation 41.8	149.3 mg/dl Standard Deviation 44.2
Fasting Glucose Week 24	149.2 mg/dl Standard Deviation 44.0	153.7 mg/dl Standard Deviation 51.3

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), week 12, week 24

Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline

Standard lab measurement for fasting insulin assessment

Outcome measures

Measure	Diet Beverage n=89 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=88 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Fasting Insulin (Pmol/L) Baseline	128.0 pmol/L Standard Deviation 97.1	138.5 pmol/L Standard Deviation 134.1
Fasting Insulin (Pmol/L) Week 12	135.7 pmol/L Standard Deviation 141.0	134.2 pmol/L Standard Deviation 145.0
Fasting Insulin (Pmol/L) Week 24	143.5 pmol/L Standard Deviation 145.4	144.2 pmol/L Standard Deviation 144.0

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in),12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline

Fructosamine (umol/L) represents usual glycemia over the past 2-3 weeks, and is considered a valid marker of short term clinical glycemic patterns by the American Diabetes Association

Outcome measures

Measure	Diet Beverage n=90 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=88 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Fructosamine Baseline	273.2 umol/L Standard Deviation 44.8	285.5 umol/L Standard Deviation 42.4
Fructosamine Week 12	272.1 umol/L Standard Deviation 43.5	286.6 umol/L Standard Deviation 47.2
Fructosamine Week 24	273.0 umol/L Standard Deviation 51.3	291.6 umol/L Standard Deviation 45.8

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points 2 participants who withdrew after baseline

Weight measured on standardized scale in gown

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Weight (kg) Baseline	102.1 kg Standard Deviation 21.1	96.1 kg Standard Deviation 21.5
Weight (kg) Week 12	101.5 kg Standard Deviation 20.4	95.8 kg Standard Deviation 21.8
Weight (kg) Week 24	101.2 kg Standard Deviation 20.6	95.9 kg Standard Deviation 21.9

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline

Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk

Outcome measures

Measure	Diet Beverage n=90 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=88 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Total Cholesterol (mg/dL) Baseline	165.9 mg/dl Standard Deviation 41.3	163.6 mg/dl Standard Deviation 40.9
Total Cholesterol (mg/dL) Week 12	164.8 mg/dl Standard Deviation 39.5	163.6 mg/dl Standard Deviation 40.3
Total Cholesterol (mg/dL) Week 24	161.1 mg/dl Standard Deviation 36.4	163.4 mg/dl Standard Deviation 40.1

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in),12, 24 weeks

eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m^2

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Kidney Function Baseline	83.2 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 21.1	81.5 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 20.0
Kidney Function Week 12	82.8 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 20.5	80.8 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 19.5
Kidney Function Week 24	82.0 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 20.7	80.9 eGFR-Cystatin-C (mL/min/1.73 m^2) Standard Deviation 20.7

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in),12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

Systolic blood pressure (mmHg)

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Systolic Blood Pressure Baseline	136.3 mmHG Standard Deviation 15.0	131.9 mmHG Standard Deviation 15.0
Systolic Blood Pressure Week 12	135.5 mmHG Standard Deviation 14.8	129.5 mmHG Standard Deviation 13.1
Systolic Blood Pressure Week 24	135.6 mmHG Standard Deviation 15.6	129.6 mmHG Standard Deviation 14.8

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

Standard part of blood pressure measurement (mmHG)

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=89 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Diastolic Blood Pressure Baseline	78.5 mmHG Standard Deviation 7.7	76.6 mmHG Standard Deviation 7.4
Diastolic Blood Pressure Week 12	78.3 mmHG Standard Deviation 8.4	75.4 mmHG Standard Deviation 7.6
Diastolic Blood Pressure Week 24	77.7 mmHG Standard Deviation 8.6	75.6 mmHG Standard Deviation 7.2

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

Apo-AI the major protein component of high density lipoprotein (HDL)

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Apolipoprotein-AI Baseline	146.6 mg/dL Standard Deviation 24.3	150.3 mg/dL Standard Deviation 23.3
Apolipoprotein-AI Week 12	148.0 mg/dL Standard Deviation 25.5	151.0 mg/dL Standard Deviation 23.7
Apolipoprotein-AI Week 24	147.2 mg/dL Standard Deviation 22.5	152.7 mg/dL Standard Deviation 24.2

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Apolipoprotein B Baseline	88.0 mg/dL Standard Deviation 21.1	85.0 mg/dL Standard Deviation 24.0
Apolipoprotein B Week 12	88.0 mg/dL Standard Deviation 23.1	86.6 mg/dL Standard Deviation 25.1
Apolipoprotein B Week 24	85.4 mg/dL Standard Deviation 21.3	86.8 mg/dL Standard Deviation 25.8

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

A protein involved in forming blood clots in the body

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Fibrinogen (mg/dL) Baseline	265.0 mg/dL Standard Deviation 51.9	269.3 mg/dL Standard Deviation 55.1
Fibrinogen (mg/dL) Week 12	268.7 mg/dL Standard Deviation 55.7	263.1 mg/dL Standard Deviation 50.9
Fibrinogen (mg/dL) Week 24	270.4 mg/dL Standard Deviation 53.3	265.4 mg/dL Standard Deviation 43.2

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number of measurements over time reflect ability to collect data during covid-19 epidemic, participant dropout, and removing 3 outliers (CRP\>30)

biomarker of inflammation

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
C-reactive Protein Baseline	3.93 mg/L Standard Deviation 3.73	3.54 mg/L Standard Deviation 3.27
C-reactive Protein Week 12	3.60 mg/L Standard Deviation 3.81	3.56 mg/L Standard Deviation 3.12
C-reactive Protein Week 24	3.85 mg/L Standard Deviation 4.42	3.53 mg/L Standard Deviation 3.35

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

AST (aspartate aminotransferase) is an enzyme that reflects liver function

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Aspartate Aminotransferase (AST) (U/L) Baseline	21.9 U/L Standard Deviation 9.5	24.9 U/L Standard Deviation 15.2
Aspartate Aminotransferase (AST) (U/L) Week 12	22.5 U/L Standard Deviation 11.3	23.9 U/L Standard Deviation 15.4
Aspartate Aminotransferase (AST) (U/L) Week 24	21.9 U/L Standard Deviation 8.7	23.9 U/L Standard Deviation 13.0

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

ALT (alanine transaminase) is an enzyme, a protein that reflects liver function

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Aminotransferase (ALT) (U/L) Baseline	26.6 U/L Standard Deviation 14.5	28.2 U/L Standard Deviation 21.6
Aminotransferase (ALT) (U/L) Week 12	26.8 U/L Standard Deviation 15.8	27.1 U/L Standard Deviation 23.2
Aminotransferase (ALT) (U/L) Week 24	26.6 U/L Standard Deviation 15.0	26.3 U/L Standard Deviation 19.0

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

ALP is an enzyme, a protein, that reflects liver function

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=90 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Alkaline Phosphatase (ALKPhos ) (U/L) Baseline	88.0 U/L Standard Deviation 41.8	83.3 U/L Standard Deviation 24.7
Alkaline Phosphatase (ALKPhos ) (U/L) Week 12	90.1 U/L Standard Deviation 42.9	82.6 U/L Standard Deviation 24.5
Alkaline Phosphatase (ALKPhos ) (U/L) Week 24	88.7 U/L Standard Deviation 41.9	83.4 U/L Standard Deviation 24.6

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

Hormone measured in the blood with energy balance related role

Outcome measures

Measure	Diet Beverage n=90 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=87 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Thyroid Stimulating Hormone (TSH) Week 12	2.65 µU/mL Standard Deviation 3.32	2.32 µU/mL Standard Deviation 1.91
Thyroid Stimulating Hormone (TSH) Week 24	2.36 µU/mL Standard Deviation 1.66	2.27 µU/mL Standard Deviation 1.47
Thyroid Stimulating Hormone (TSH) Baseline	2.45 µU/mL Standard Deviation 1.58	2.17 µU/mL Standard Deviation 1.34

SECONDARY outcome

Timeframe: Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2).

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The Healthy Eating Index (HEI) is a measure of diet quality used to assess how well a set of foods aligns with key recommendations and dietary patterns published in the Dietary Guidelines for Americans (Dietary Guidelines). The overall HEI scores are made up of 13 components that reflect the different food groups and key recommendations in the Dietary Guidelines for Americans. The HEI is scored 0-100 (low to high), with higher scores representing greater reported intake of an overall dietary pattern aligning with USDA Dietary Guidelines. In the SODAS study, dietary intake was assessed by multiple unannounced 24-hour dietary recalls that occurred during the 2-week run-in period to assess usual habits (2 recalls over 2 weeks) and the active intervention (5 recalls over 24 weeks: 2 to 3 recalls during weeks 1-12 (period 1), and 2 to 3 recalls during weeks 13-24 (period 2). to measure any changes in diet quality. Scores during each period represent the average score of recalls.

Outcome measures

Measure	Diet Beverage n=91 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=89 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Dietary Quality (Healthy Eating Index -HEI) Baseline	54.7 units on a scale Standard Deviation 12.0	53.7 units on a scale Standard Deviation 13.6
Dietary Quality (Healthy Eating Index -HEI) Period 1	54.8 units on a scale Standard Deviation 13.2	53.1 units on a scale Standard Deviation 12.7
Dietary Quality (Healthy Eating Index -HEI) Period 2	53.3 units on a scale Standard Deviation 12.3	51.7 units on a scale Standard Deviation 13.4

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The Diabetes Health Profile (DHP-18) is used to assess health related quality of life in diabetes across three domains (psychological distress, barriers to activity and disinhibited eating). Each item is scored on a 4-point scale, and the subscale scores are then rescaled to a 0-100 range, with higher scores indicating poorer well-being.

Outcome measures

Measure	Diet Beverage n=78 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=85 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
The Diabetes Health Profile (DHP-18) Baseline	79.6 units on a scale Standard Deviation 11.1	77.9 units on a scale Standard Deviation 11.1
The Diabetes Health Profile (DHP-18) Week 12	79.8 units on a scale Standard Deviation 9.98	78.1 units on a scale Standard Deviation 10.9
The Diabetes Health Profile (DHP-18) Week 24	80.6 units on a scale Standard Deviation 11.1	78.6 units on a scale Standard Deviation 11.7

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The FCI is a valid and reliable self-report measure of specific food cravings. The inventory consists of 4 factors or subscales measuring cravings for high fats (8 items), carbohydrates/starches (8 items), sweets (8 items), and fast food fats (4 items), and a total score is calculated by summing the subscales. Participants rate each food on a 5-point Likert scale ranging from 0 (never) to 4 (always/almost every day). We calculated the total score by summing the individual item responses in each subscale. Higher scores indicate more frequent cravings of the 28 items.

Outcome measures

Measure	Diet Beverage n=78 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=80 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Food Craving Inventory (FCI) Baseline	33.9 units on a scale Standard Deviation 15.1	35.4 units on a scale Standard Deviation 14.8
Food Craving Inventory (FCI) Week 12	29.8 units on a scale Standard Deviation 15.8	30.9 units on a scale Standard Deviation 15.4
Food Craving Inventory (FCI) Week 24	27.1 units on a scale Standard Deviation 15.9	31.2 units on a scale Standard Deviation 14.3

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 12, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The Pittsburgh Sleep Quality Index (PSQI) is a self-report questionnaire that assesses sleep quality over a one-month time interval. Each component score of the PSQI ranges from 0 to 3, with 3 indicating the greatest dysfunction or disturbance. The seven component scores are then summed to obtain a global PSQI score, which ranges from 0 to 21. Higher scores indicate poorer sleep quality, with a score greater than 5 suggesting significant sleep difficulties

Outcome measures

Measure	Diet Beverage n=66 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=64 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
The Pittsburgh Sleep Quality Index (PSQI) Baseline	6.0 units on a scale Standard Deviation 2.7	6.8 units on a scale Standard Deviation 3.0
The Pittsburgh Sleep Quality Index (PSQI) Week 12	6.0 units on a scale Standard Deviation 3.1	6.5 units on a scale Standard Deviation 3.1
The Pittsburgh Sleep Quality Index (PSQI) Week 24	5.9 units on a scale Standard Deviation 2.9	7.1 units on a scale Standard Deviation 3.2

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The medication effect score (MES) is a measure of overall diabetes regimen intensity, and is based on the dosages of medications used and their potencies. The MES is calculated for each diabetes medication in a regimen using the following equation: (actual drug dose/maximum drug dose) × drug-specific adjustment factor. The adjustment factor equates to the expected decrease in HbA1c achieved by the drug as monotherapy. The MES presumes a linear relationship between medication dosage and HbA1c, and the sum of MES values attributed to individual medications represents the maximum A1c reduction that may be expected by the regimen. It is a continuous variable with range 0 (no medications), and the maximum achievable MES is patient specific and dependent on the total number of and dose of medications reported.

Outcome measures

Measure	Diet Beverage n=89 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=84 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Medication Effect Score (MES) Week 0	1.64 units on a scale Standard Deviation 1.05	2.09 units on a scale Standard Deviation 1.40
Medication Effect Score (MES) Week 6	1.64 units on a scale Standard Deviation 1.06	2.05 units on a scale Standard Deviation 1.36
Medication Effect Score (MES) Week 12	1.63 units on a scale Standard Deviation 1.05	2.03 units on a scale Standard Deviation 1.33
Medication Effect Score (MES) Week 18	1.64 units on a scale Standard Deviation 1.06	2.02 units on a scale Standard Deviation 1.35
Medication Effect Score (MES) Week 24	1.64 units on a scale Standard Deviation 1.06	2.01 units on a scale Standard Deviation 1.36

SECONDARY outcome

Timeframe: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks

Population: Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline

The therapeutic intensity score (TIS) is a summary measure that accounts for the number of medications and the relative doses a patient received to lower blood pressure. It is a continuous variable with range 0 (no medications), and the maximum achievable TIS is patient specific and dependent on the total number of antihypertensive medications reported.

Outcome measures

Measure	Diet Beverage n=86 Participants Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners. Diet Beverage: Participants will receive and consume three daily servings (24 ounces) of a non-caloric commercial diet beverage of their choice sweetened with FDA approved artificial sweeteners.	Water n=84 Participants Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages. Water: Participants will receive and consume three daily servings (24 ounces) of plain bottled/canned water in place of their usual commercial diet beverage. The water will be unflavored, unsweetened, non-caloric, and may be plain or sparkling. Participants randomized to consume water will be instructed to avoid intake of diet beverages.
Therapeutic Intensity Score (TIS) Week 0	0.41 score on a scale Standard Deviation 0.51	0.42 score on a scale Standard Deviation 0.43
Therapeutic Intensity Score (TIS) Week 6	0.40 score on a scale Standard Deviation 0.46	0.41 score on a scale Standard Deviation 0.43
Therapeutic Intensity Score (TIS) Week 12	0.42 score on a scale Standard Deviation 0.49	0.42 score on a scale Standard Deviation 0.44
Therapeutic Intensity Score (TIS) Week 18	0.41 score on a scale Standard Deviation 0.49	0.43 score on a scale Standard Deviation 0.45
Therapeutic Intensity Score (TIS) Week 24	0.41 score on a scale Standard Deviation 0.49	0.42 score on a scale Standard Deviation 0.45

Adverse Events

Diet Beverage

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Water

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

Dr. Andrew Odegaard

University of California, Irvine

Phone: 949-824-8544

Email: aodegaar@hs.uci.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place