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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01DK117028-01A1 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| University of Minnesota | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Diet Beverage | Active Comparator | 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 | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Diet Beverage | Behavioral | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| HbA1c | Glycated hemoglobin | Time 0 (directly after 2-week run-in), 12, 24 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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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:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of California, Irvine | Irvine | California | 92697 | United States | ||
| University of Minnesota |
It is not yet known if there will be a plan to make IPD available.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| FG001 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | HbA1c | Glycated hemoglobin | 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) | Posted | Mean | Standard Deviation | Hba1c(%) | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
26 weeks (2 week run-in period and 24-week randomized intervention period)
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Andrew Odegaard | University of California, Irvine | 949-824-8544 | aodegaar@hs.uci.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 30, 2019 | Jul 17, 2025 | Prot_001.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Apr 30, 2024 | May 7, 2024 | SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D000081229 | Artificially Sweetened Beverages |
| D014867 | Water |
| ID | Term |
|---|---|
| D001628 | Beverages |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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This study is testing the effect of commercial 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. We 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).
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All nursing staff/phlebotomist collecting physical samples, and the lab analyzing the samples will be masked to the trial arm the participant is in. The biostatistician performing the final analyses will also be masked.
| Water | Behavioral | 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. |
|
| 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. | 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 | 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 0 (directly after 2-week run-in), 12, 24 weeks |
| Fasting Insulin (Pmol/L) | Standard lab measurement for fasting insulin assessment | 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 0 (directly after 2-week run-in),12, 24 weeks |
| Weight (kg) | Weight measured on standardized scale in gown | 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 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 0 (directly after 2-week run-in),12, 24 weeks |
| Systolic Blood Pressure | Systolic blood pressure (mmHg) | Time 0 (directly after 2-week run-in),12, 24 weeks |
| Diastolic Blood Pressure | Standard part of blood pressure measurement (mmHG) | 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 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 0 (directly after 2-week run-in), 12, 24 weeks |
| Fibrinogen (mg/dL) | A protein involved in forming blood clots in the body | Time 0 (directly after 2-week run-in), 12, 24 weeks |
| C-reactive Protein | biomarker of inflammation | 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 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 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 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 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. | 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 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 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 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 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 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks |
| Minneapolis |
| Minnesota |
| 55454 |
| United States |
| BG001 | 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. |
| BG002 | Total | Total of all reporting groups |
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | States (California) and (Minnesota) | Number | participants |
|
| OG001 | 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. |
|
|
| Secondary | 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. | Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | % Time in Range | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) |
|
|
|
| Secondary | 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. | Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | SD of mean glucose (mg/dl) | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) |
|
|
|
| Secondary | Mean Glucose (mg/dl) | A measure of the mean, 24 hour glucose concentration calculated across all recorded glucose readings during the wear period | Number analyzed at different time points reflects attrition due to device failure, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dl | All 14 day periods: Run-in (2-weeks, usual-baseline), weeks 11 and 12 (14 days), weeks 23 and 24 (14 days) |
|
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|
| Secondary | Fasting Glucose | Standard (mg/dl) measure taken fasting (morning) during baseline, 12 weeks, 24 weeks | Number analyzed at different time points reflects attrition due to invalid lab sample, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dl | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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|
| Secondary | Fasting Insulin (Pmol/L) | Standard lab measurement for fasting insulin assessment | Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | pmol/L | Time 0 (directly after 2-week run-in), week 12, week 24 |
|
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|
| Secondary | 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 | Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | umol/L | Time 0 (directly after 2-week run-in),12, 24 weeks |
|
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| Secondary | Weight (kg) | Weight measured on standardized scale in gown | Number analyzed at different time points 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | kg | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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|
| Secondary | Total Cholesterol (mg/dL) | Total cholesterol was measured as part of a lipid panel, a standard measurement for assessing clinical CVD risk | Number analyzed at different time points reflects attrition due to invalid samples, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dl | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Kidney Function | eGFR-Cystatin-C (estimated glomerular filtration rate) = mL/min/1.73 m^2 | Posted | Mean | Standard Deviation | eGFR-Cystatin-C (mL/min/1.73 m^2) | Time 0 (directly after 2-week run-in),12, 24 weeks |
|
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| Secondary | Systolic Blood Pressure | Systolic blood pressure (mmHg) | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mmHG | Time 0 (directly after 2-week run-in),12, 24 weeks |
|
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| Secondary | Diastolic Blood Pressure | Standard part of blood pressure measurement (mmHG) | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mmHG | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Apolipoprotein-AI | Apo-AI the major protein component of high density lipoprotein (HDL) | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dL | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Apolipoprotein B | ApoB levels indicate the atherogenic particle concentration independent of the particle cholesterol content | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dL | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Fibrinogen (mg/dL) | A protein involved in forming blood clots in the body | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | mg/dL | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | C-reactive Protein | biomarker of inflammation | Number of measurements over time reflect ability to collect data during covid-19 epidemic, participant dropout, and removing 3 outliers (CRP>30) | Posted | Mean | Standard Deviation | mg/L | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Aspartate Aminotransferase (AST) (U/L) | AST (aspartate aminotransferase) is an enzyme that reflects liver function | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | U/L | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Aminotransferase (ALT) (U/L) | ALT (alanine transaminase) is an enzyme, a protein that reflects liver function | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | U/L | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Alkaline Phosphatase (ALKPhos ) (U/L) | ALP is an enzyme, a protein, that reflects liver function | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | U/L | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | Thyroid Stimulating Hormone (TSH) | Hormone measured in the blood with energy balance related role | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | µU/mL | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | 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. | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | units on a scale | Run-in period (2 weeks) - baseline, Week 1-12 (period 1), Week 13-24 (period 2). |
|
|
|
| Secondary | 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. | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | units on a scale | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | 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. | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | units on a scale | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | 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 | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | units on a scale | Time 0 (directly after 2-week run-in), 12, 24 weeks |
|
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| Secondary | 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. | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | units on a scale | Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks |
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| Secondary | 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. | Number analyzed at different time points reflects attrition due to data collection, COVID-19 restrictions, and 2 participants who withdrew after baseline | Posted | Mean | Standard Deviation | score on a scale | Time 0 (directly after 2-week run-in), 6, 12, 18, 24 weeks |
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| 0 |
| 91 |
| 0 |
| 91 |
| 0 |
| 91 |
| EG001 | 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. | 0 | 90 | 0 | 90 | 0 | 90 |
Not provided
Not provided
| D004700 | Endocrine System Diseases |
| D006878 |
| Hydroxides |
| D000468 | Alkalies |
| D007287 | Inorganic Chemicals |
| D000838 | Anions |
| D007477 | Ions |
| D004573 | Electrolytes |
| D010087 | Oxides |
| D017601 | Oxygen Compounds |
| Week 11-12 |
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