An interventional study of Diet Beverage and Water in Type 2 Diabetes, sponsored by University of California, Irvine. Completed at 2 sites in United States. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2025-09-11.
Sponsored by University of California, Irvine · Not applicable, Interventional, and Prevention
Diet beverages sweetened with artificial sweeteners occupy a unique category in the food environment as they are a source of intensely sweet taste with no calories. Diet beverages are the single largest contributor to artificial sweetener intake in the U.S. diet, and people with diabetes are the highest consumers of diet beverages, tending to consume them as a replacement for dietary sources of sugar, especially in place of sugar-sweetened beverages. This behavior has been endorsed by dietetic and scientific organizations, and diet beverages are marketed as being synonymous with better health, suitable for weight loss, and thus advantageous for diabetes control. The underlying public health concern is that there are few data to support or refute the benefit or harm of habitual diet beverage consumption by people with diabetes; therefore randomized trials with relevant outcomes must be conducted because they would address many limitations of previous research and have major implications for dietary recommendations on diet beverage intake and primary and secondary prevention of chronic disease. To begin addressing this important scientific gap the investigators are testing the effect of diet beverage intake on diabetes control parameters in free-living adults with type 2 diabetes in a randomized, two arm parallel trial with a run-in period of 2-weeks and an active intervention period of 24-weeks. This study will recruit 200 patients with type 2 diabetes who are usual consumers of commercial diet beverages and randomize them to receive and consume either: 1) A commercial diet beverage of choice (3 servings or 24 oz. daily); or 2) Unflavored bottled water of choice (sparkling or plain) (3 servings or 24 oz. daily). The primary outcome will be a central measure of clinical diabetes control in glycated hemoglobin (HbA1c). The study will also measure the nature and magnitude of glycemic excursions via continuous glucose monitors, as well as clinical markers of cardiometabolic risk and kidney function. Lastly, investigators will measure plausible mechanisms whereby diet beverage intake may alter risk by assessing the effect of diet beverage intake on the functional composition of the gut microbiome via stool samples and comprehensive metabolomics, satiety hormones, as well as usual dietary intake, and upstream behavioral pathways which may inform dietary intake patterns.
9,359 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,318 are open to participants now.
This study's enrollment of 181 is above the median of 80 across 7,525 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →University of California, Irvine is the lead sponsor of 466 studies on the registry; 96 are open to participants now.
Of its 41 completed or terminated interventional studies of FDA-regulated products, 30 (73%) have results posted.
Counted across the registry records on this site, refreshed daily.
Inclusion criteria: We will include men, women and non-binary participants with T2D, age 35 years and older, able to provide informed consent, otherwise healthy, who meet the following criteria:
Exclusion Criteria:
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.
Behavioral: Diet Beverage
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.
Behavioral: Water
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.
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
Glycated hemoglobin
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Time In Range
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.
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Glycemic Variability
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.
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Mean Glucose (mg/dl)
A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period
Time frame: All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days)
Fasting Glucose
Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Fasting Insulin (Pmol/L)
Standard lab measurement for fasting insulin assessment
Time frame: Time 0 (directly after 2-week run-in), week 12, week 24
Fructosamine
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
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
Weight (kg)
Weight measured on standardized scale in gown
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Total Cholesterol (mg/dL)
Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Kidney Function
eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m\^2
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
Systolic Blood Pressure
Systolic blood pressure (mmHg)
Time frame: Time 0 (directly after 2-week run-in),12, 24 weeks
Diastolic Blood Pressure
Standard part of blood pressure measurement (mmHG)
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Apolipoprotein-AI
Apo-AI the major protein component of high density lipoprotein (HDL)
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Apolipoprotein B
ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Fibrinogen (mg/dL)
A protein involved in forming blood clots in the body
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
C-reactive Protein
biomarker of inflammation
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Aspartate Aminotransferase (AST) (U/L)
AST (aspartate aminotransferase) is an enzyme that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Aminotransferase (ALT) (U/L)
ALT (alanine transaminase) is an enzyme, a protein that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Alkaline Phosphatase (ALKPhos ) (U/L)
ALP is an enzyme, a protein, that reflects liver function
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Thyroid Stimulating Hormone (TSH)
Hormone measured in the blood with energy balance related role
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Dietary Quality (Healthy Eating Index -HEI)
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.
Time frame: Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2).
The Diabetes Health Profile (DHP-18)
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.
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Food Craving Inventory (FCI)
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.
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
The Pittsburgh Sleep Quality Index (PSQI)
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
Time frame: Time 0 (directly after 2-week run-in), 12, 24 weeks
Medication Effect Score (MES)
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.
Time frame: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks
Therapeutic Intensity Score (TIS)
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.
Time frame: Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks
| Milestone | Diet Beverage | Water |
|---|---|---|
| Started | 91 | 90 |
| Completed | 91 | 88 |
| Not completed | 0 | 2 |
| Withdrew: Lost to follow-up | 0 | 2 |
Glycated hemoglobin
| Hba1c(%) | Diet Beverage | Water |
|---|---|---|
| Time 0 | 7.19 ± 1.10 | 7.20 ± 0.69 |
| 12 weeks | 7.13 ± 1.02 | 7.43 ± 1.02 |
| 24 weeks | 7.14 ± 1.19 | 7.44 ± 1.04 |
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.
| % Time in Range | Diet Beverage | Water |
|---|---|---|
| Baseline | 76.0 ± 19.2 | 72.3 ± 20.9 |
| Week 11-12 | 75.2 ± 22.6 | 66.9 ± 26.2 |
| Week 23-24 | 72.8 ± 23.2 | 64.7 ± 26.5 |
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.
| SD of mean glucose (mg/dl) | Diet Beverage | Water |
|---|---|---|
| Baseline | 39.6 ± 14.7 | 42.0 ± 13.1 |
| Weeks 11-12 | 40.0 ± 12.9 | 44.9 ± 15.4 |
| Weeks 23-24 | 40.8 ± 14.9 | 45.8 ± 16.3 |
A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period
| mg/dl | Diet Beverage | Water |
|---|---|---|
| Baseline | 147.3 ± 42.1 | 151.4 ± 33.1 |
| Weeks 11-12 | 149.4 ± 46.4 | 161.2 ± 50.5 |
| Weeks 23-24 | 153.1 ± 50.7 | 162.3 ± 47.3 |
Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks
| mg/dl | Diet Beverage | Water |
|---|---|---|
| Baseline | 147.5 ± 40.0 | 147.6 ± 36.2 |
| Week 12 | 146.2 ± 41.8 | 149.3 ± 44.2 |
| Week 24 | 149.2 ± 44.0 | 153.7 ± 51.3 |
Standard lab measurement for fasting insulin assessment
| pmol/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 128.0 ± 97.1 | 138.5 ± 134.1 |
| Week 12 | 135.7 ± 141.0 | 134.2 ± 145.0 |
| Week 24 | 143.5 ± 145.4 | 144.2 ± 144.0 |
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
| umol/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 273.2 ± 44.8 | 285.5 ± 42.4 |
| Week 12 | 272.1 ± 43.5 | 286.6 ± 47.2 |
| Week 24 | 273.0 ± 51.3 | 291.6 ± 45.8 |
Weight measured on standardized scale in gown
| kg | Diet Beverage | Water |
|---|---|---|
| Baseline | 102.1 ± 21.1 | 96.1 ± 21.5 |
| Week 12 | 101.5 ± 20.4 | 95.8 ± 21.8 |
| Week 24 | 101.2 ± 20.6 | 95.9 ± 21.9 |
Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk
| mg/dl | Diet Beverage | Water |
|---|---|---|
| Baseline | 165.9 ± 41.3 | 163.6 ± 40.9 |
| Week 12 | 164.8 ± 39.5 | 163.6 ± 40.3 |
| Week 24 | 161.1 ± 36.4 | 163.4 ± 40.1 |
eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m\^2
| eGFR-Cystatin-C (mL/min/1.73 m^2) | Diet Beverage | Water |
|---|---|---|
| Baseline | 83.2 ± 21.1 | 81.5 ± 20.0 |
| Week 12 | 82.8 ± 20.5 | 80.8 ± 19.5 |
| Week 24 | 82.0 ± 20.7 | 80.9 ± 20.7 |
Systolic blood pressure (mmHg)
| mmHG | Diet Beverage | Water |
|---|---|---|
| Baseline | 136.3 ± 15.0 | 131.9 ± 15.0 |
| Week 12 | 135.5 ± 14.8 | 129.5 ± 13.1 |
| Week 24 | 135.6 ± 15.6 | 129.6 ± 14.8 |
Standard part of blood pressure measurement (mmHG)
| mmHG | Diet Beverage | Water |
|---|---|---|
| Baseline | 78.5 ± 7.7 | 76.6 ± 7.4 |
| Week 12 | 78.3 ± 8.4 | 75.4 ± 7.6 |
| Week 24 | 77.7 ± 8.6 | 75.6 ± 7.2 |
Apo-AI the major protein component of high density lipoprotein (HDL)
| mg/dL | Diet Beverage | Water |
|---|---|---|
| Baseline | 146.6 ± 24.3 | 150.3 ± 23.3 |
| Week 12 | 148.0 ± 25.5 | 151.0 ± 23.7 |
| Week 24 | 147.2 ± 22.5 | 152.7 ± 24.2 |
ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content
| mg/dL | Diet Beverage | Water |
|---|---|---|
| Baseline | 88.0 ± 21.1 | 85.0 ± 24.0 |
| Week 12 | 88.0 ± 23.1 | 86.6 ± 25.1 |
| Week 24 | 85.4 ± 21.3 | 86.8 ± 25.8 |
A protein involved in forming blood clots in the body
| mg/dL | Diet Beverage | Water |
|---|---|---|
| Baseline | 265.0 ± 51.9 | 269.3 ± 55.1 |
| Week 12 | 268.7 ± 55.7 | 263.1 ± 50.9 |
| Week 24 | 270.4 ± 53.3 | 265.4 ± 43.2 |
biomarker of inflammation
| mg/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 3.93 ± 3.73 | 3.54 ± 3.27 |
| Week 12 | 3.60 ± 3.81 | 3.56 ± 3.12 |
| Week 24 | 3.85 ± 4.42 | 3.53 ± 3.35 |
AST (aspartate aminotransferase) is an enzyme that reflects liver function
| U/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 21.9 ± 9.5 | 24.9 ± 15.2 |
| Week 12 | 22.5 ± 11.3 | 23.9 ± 15.4 |
| Week 24 | 21.9 ± 8.7 | 23.9 ± 13.0 |
ALT (alanine transaminase) is an enzyme, a protein that reflects liver function
| U/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 26.6 ± 14.5 | 28.2 ± 21.6 |
| Week 12 | 26.8 ± 15.8 | 27.1 ± 23.2 |
| Week 24 | 26.6 ± 15.0 | 26.3 ± 19.0 |
ALP is an enzyme, a protein, that reflects liver function
| U/L | Diet Beverage | Water |
|---|---|---|
| Baseline | 88.0 ± 41.8 | 83.3 ± 24.7 |
| Week 12 | 90.1 ± 42.9 | 82.6 ± 24.5 |
| Week 24 | 88.7 ± 41.9 | 83.4 ± 24.6 |
Hormone measured in the blood with energy balance related role
| µU/mL | Diet Beverage | Water |
|---|---|---|
| Baseline | 2.45 ± 1.58 | 2.17 ± 1.34 |
| Week 12 | 2.65 ± 3.32 | 2.32 ± 1.91 |
| Week 24 | 2.36 ± 1.66 | 2.27 ± 1.47 |
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.
| units on a scale | Diet Beverage | Water |
|---|---|---|
| Baseline | 54.7 ± 12.0 | 53.7 ± 13.6 |
| Period 1 | 54.8 ± 13.2 | 53.1 ± 12.7 |
| Period 2 | 53.3 ± 12.3 | 51.7 ± 13.4 |
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.
| units on a scale | Diet Beverage | Water |
|---|---|---|
| Baseline | 79.6 ± 11.1 | 77.9 ± 11.1 |
| Week 12 | 79.8 ± 9.98 | 78.1 ± 10.9 |
| Week 24 | 80.6 ± 11.1 | 78.6 ± 11.7 |
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.
| units on a scale | Diet Beverage | Water |
|---|---|---|
| Baseline | 33.9 ± 15.1 | 35.4 ± 14.8 |
| Week 12 | 29.8 ± 15.8 | 30.9 ± 15.4 |
| Week 24 | 27.1 ± 15.9 | 31.2 ± 14.3 |
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
| units on a scale | Diet Beverage | Water |
|---|---|---|
| Baseline | 6.0 ± 2.7 | 6.8 ± 3.0 |
| Week 12 | 6.0 ± 3.1 | 6.5 ± 3.1 |
| Week 24 | 5.9 ± 2.9 | 7.1 ± 3.2 |
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.
| units on a scale | Diet Beverage | Water |
|---|---|---|
| Week 0 | 1.64 ± 1.05 | 2.09 ± 1.40 |
| Week 6 | 1.64 ± 1.06 | 2.05 ± 1.36 |
| Week 12 | 1.63 ± 1.05 | 2.03 ± 1.33 |
| Week 18 | 1.64 ± 1.06 | 2.02 ± 1.35 |
| Week 24 | 1.64 ± 1.06 | 2.01 ± 1.36 |
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.
| score on a scale | Diet Beverage | Water |
|---|---|---|
| Week 0 | 0.41 ± 0.51 | 0.42 ± 0.43 |
| Week 6 | 0.40 ± 0.46 | 0.41 ± 0.43 |
| Week 12 | 0.42 ± 0.49 | 0.42 ± 0.44 |
| Week 18 | 0.41 ± 0.49 | 0.43 ± 0.45 |
| Week 24 | 0.41 ± 0.49 | 0.42 ± 0.45 |
Collected over 26 weeks (2 week run-in period and 24-week randomized intervention period). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Diet Beverage | 0/91 (0%) | 0/91 (0%) | 0/91 (0%) |
| Water | 0/90 (0%) | 0/90 (0%) | 0/90 (0%) |
| Age, Continuous(years) | Diet Beverage | Water | Total |
|---|---|---|---|
| Mean | 59.6 ± 10.4 | 60.7 ± 10.1 | 60.1 ± 10.2 |
| Sex: Female, Male(Participants) | Diet Beverage | Water | Total |
|---|---|---|---|
| Female | 47 | 47 | 94 |
| Male | 44 | 43 | 87 |
| Race/Ethnicity, Customized(Participants) | Diet Beverage | Water | Total |
|---|---|---|---|
| African American or Black | 4 | 2 | 6 |
| Hispanic/Latino(a) | 9 | 11 | 20 |
| White (non-Hispanic) | 68 | 67 | 135 |
| Other | 10 | 10 | 20 |
| Region of Enrollment(participants) | Diet Beverage | Water | Total |
|---|---|---|---|
| United States | 91 | 90 | 181 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No — It is not yet known if there will be a plan to make IPD available.
This study is completed, as verified in Sep 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.
University of California, Irvine