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| ID | Type | Description | Link |
|---|---|---|---|
| R01DK128900 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| Beth Israel Deaconess Medical Center | OTHER |
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
| Sheikh Khalifa Stroke Institute at Johns Hopkins | UNKNOWN |
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The objective of the DASH4D trial is to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet that is typical of what many Americans with diabetes eat and (b) lower sodium intake vs. higher sodium intake on blood pressure (BP). The core design is a single-site, 4-period, crossover feeding study with 5-week periods. Participants are fed each of four isocaloric diets, presented in random order. The primary contrast of interest is DASH4D diet with lower sodium vs. comparison diet with higher sodium.
DASH4D Main Trial:
In persons with and without diabetes, elevated blood pressure (BP) is the leading cause of stroke and a major risk factor for other cardiovascular diseases, including coronary heart disease and heart failure. Strategies that effectively lower BP include drug therapy and lifestyle modification. Lifestyle modifications, particularly dietary approaches, have been shown to lower BP in persons without diabetes. However, there is a striking dearth of evidence on BP-lowering, lifestyle modifications, other than weight loss, in persons with diabetes. The DASH4D trial is designed to provide this evidence.
The DASH4D trial builds upon the investigators' experience in four NIH-sponsored feeding studies (DASH, DASH-Sodium, OmniHeart, and OmniCarb). The trial will enroll approximately 100 adults with Type 2 diabetes, systolic BP 120-159 mmHg, and diastolic BP <100 mmHg, to determine the effects, alone and combined, of (a) the DASH4D diet (a DASH-style diet modified for people with diabetes) vs. comparison diet (typical of what many Americans with diabetes eat) and (b) lower sodium intake vs. higher sodium intake on BP.
The core design is a four-period, single-site, crossover feeding study with 5-week periods. Participants are fed each of four diets, presented in random order:
The primary contrast of interest is the DASH4D diet with lower sodium vs. the comparison diet with higher sodium.
The DASH4D diet is similar to the original DASH diet, but is lower in carbohydrates and higher in unsaturated fat than the original DASH diet, and therefore, is more consistent with dietary recommendations for persons with diabetes than the original DASH diet. The comparison diet reflects what many persons with diabetes currently consume. The lower sodium intake of approximately 1500 mg/day (at 2000 kcal) has been shown to lower BP in persons without diabetes, and has been recommended in some dietary guidelines. The higher sodium intake of approximately 3700 mg/day (at 2000 kcal) is based on estimated average intake in the US.
Outcomes are measured at the end of each feeding period. The primary outcome is end-of-period, office-based systolic BP. Other outcomes are diastolic BP, measures of glycemia, plasma lipid risk factors, patient symptoms, and estimated cardiovascular disease risk.
Similar to the investigators' prior feeding studies, the investigators expect that the results of the DASH4D trial will be immediately applicable to public health and clinical guidelines and will influence nutrition policy. Furthermore, the trial will provide a rigorous platform to assess the impact of diet and sodium intake on a diverse array of other outcomes in persons with Type 2 diabetes.
DASH4D CONTINUOUS GLUCOSE MONITORING (CGM) ANCILLARY STUDY:
Continuous glucose monitoring (CGM) systems are novel technologies recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability. The DASH4D-CGM ancillary study will offer CGM to all participants in the DASH4D trial during a screening visit and during the two weeks at the end of each of four feeding periods.
CGM outcomes will be based on CGM data captured from week 3 to week 5 (up to 14 days) of each 5-week feeding period. Per current analytic recommendations, CGM outcomes will be generated using all available CGM data for each feeding period. The primary CGM outcomes are mean glucose, time-in-range (percentage of time glucose is between 70 and 180 mg/dL), and coefficient of variation. These outcomes were selected based on clinical guidelines and recommendations from a consensus statement on CGM endpoints for clinical trials.
We hypothesized that salt would have no effect on glucose. Therefore, we plan to combine data from the lower and higher sodium feeding periods for each diet to increase statistical power. Our primary aim is to examine the average difference in mean glucose, time-in-range, and coefficient of variation between the DASH4D and comparison diets.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| DASH4D diet with lower sodium | Active Comparator | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day |
|
| DASH4D diet with higher sodium | Active Comparator | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day |
|
| Comparison diet with lower sodium | Active Comparator | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day |
|
| Comparison diet with higher sodium | Other | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| DASH4D diet | Other | DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure (SBP) | After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome. | At the end of 5-week feeding period |
| Measure | Description | Time Frame |
|---|---|---|
| Diastolic Blood Pressure (DBP) | After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean diastolic blood pressure from these five blood pressures (15 total readings) will be used as a secondary outcome. |
| Measure | Description | Time Frame |
|---|---|---|
| Glycated Albumin Level | Glycated albumin percentage (%). | At the end of 5-week feeding period |
| Fructosamine Level | Fructosamine level in mmol/L. |
INCLUSION CRITERIA:
EXCLUSION CRITERIA:
Laboratory Exclusions
Medication Exclusions
Unstable dose (i.e., change in the 2 months prior to screening or prior to randomization) of any of the following:
Use of any of the following medications:
Unwillingness to keep same dose of vitamin, mineral, and botanical supplements
Any medication not compatible with participation as determined by the investigators
Medical History Exclusions
Physical Exclusions
Lifestyle and Other Exclusions
DASH4D-CGM ANCILLARY STUDY EXCLUSION CRITERIA:
All DASH4D main trial participants will be invited to participate in the embedded CGM ancillary study. Participants with the following contraindications to wearing a CGM sensor will be excluded from the ancillary study:
Note: Participants excluded from, or who do not wish to participate in, the CGM ancillary study are still allowed to participate in the DASH4D main trial if eligible.
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| Name | Affiliation | Role |
|---|---|---|
| Lawrence Appel, MD, MPH | Johns Hopkins University | Principal Investigator |
| Hsin Chieh Yeh, PhD | Johns Hopkins University | Principal Investigator |
| Scott Pilla, MD, MHS | Johns Hopkins University | Principal Investigator |
| Elizabeth Selvin, PhD | Johns Hopkins University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Johns Hopkins ProHealth | Baltimore | Maryland | 21207 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 40764427 | Derived | Fang M, Wang D, Rebholz CM, Echouffo-Tcheugui JB, Tang O, Wang NY, Mitchell CM, Pilla SJ, Appel LJ, Selvin E. DASH4D diet for glycemic control and glucose variability in type 2 diabetes: a randomized crossover trial. Nat Med. 2025 Oct;31(10):3309-3316. doi: 10.1038/s41591-025-03823-3. Epub 2025 Aug 5. | |
| 40489102 | Derived | Pilla SJ, Yeh HC, Mitchell CM, Miller ER 3rd, Oh S, White K, Durkin N, Stein AA, Charleston JB, Lu M, Hu X, Wu B, Selvin E, Fang M, Maruthur NM, Juraschek SP, Mueller NT, Wang NY, Appel LJ; DASH4D Collaborative Research Group. Dietary Patterns, Sodium Reduction, and Blood Pressure in Type 2 Diabetes: The DASH4D Randomized Clinical Trial. JAMA Intern Med. 2025 Aug 1;185(8):937-946. doi: 10.1001/jamainternmed.2025.1580. |
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105 participants were randomized to 1 of 24 possible sequences of the 4 study diets in random order (i.e., within-subjects crossover). However, 2 participants never started any study diets and 1 started the first diet but withdrew before any outcome assessments and were excluded from the analytic population (n=102). All participants were invited to the concurrent CGM Ancillary Study, but 3 did not consent, 8 changed their mind before outcome assessment, and 2 had contraindications (CGM n=89).
The DASH4D trial recruited participants from June 2021 to December 2023, primarily through mass mailings of brochures, letters to prior participants, newspaper ads, and word of mouth. Prior to enrollment, participants completed a prescreening telephone interview, 3 in-person screening visits, and a run-in period to determine eligibility for the trial prior to randomization. The study was conducted at a single-site community-based research center.
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| ID | Title | Description |
|---|---|---|
| FG000 | DASH4D Trial Analytic Population | Participants were randomized to one of 24 possible sequences of the four study diets, in random order, in this within-subjects crossover trial. The four diets were:
The DASH4D diet is a DASH-style dietary pattern, modified for people with diabetes. DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH diet lowers blood pressure. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrates. The comparison diet is a dietary pattern that is typical of what many Americans with diabetes eat. It is based on macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). Lower sodium level: 1500 mg/day (at the 2000 kilocalorie level). Higher sodium level: 3700 mg/day (at the 2000 kilocalorie level). |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| First Feeding Period (5 Weeks) |
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| Break 1 (at Least 1 Week) |
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| Second Feeding Period (5 Weeks) |
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| Break 2 (at Least 1 Week) |
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| Third Feeding Period (5 Weeks) |
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| Break 3 (at Least 1 Week) |
| ||||||||||||||||||||||||||||||||||
| Feeding Period 4 (5 Weeks) |
|
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| ID | Title | Description |
|---|---|---|
| BG000 | DASH4D All Participants | All participants who were randomized and analyzed. |
| 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 | Systolic Blood Pressure (SBP) | After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean systolic blood pressure from these five blood pressures (15 total readings) will be used as the primary outcome. | The analysis population reflects the number of participants who started the diet and completed at least one of the five blood pressure assessments during the last 2 weeks of the feeding period. | Posted | Mean | Standard Deviation | mmHg | At the end of 5-week feeding period |
|
From the start of the first 5-week feeding period until the end of the fourth 5-week feeding period, for up to 20 weeks of intervention feeding.
Study staff ascertained the following safety events of special interest: hypertension, hypotension, hyperkalemia, and hypoglycemia. Otherwise, adverse events were ascertained through participant self-report to study staff.
To be at risk for an adverse event on a particular diet, the participant needed to have started that diet. Due to the random order of diets and some drop out during the study, not all participants started each diet.
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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 | DASH4D Diet With Lower Sodium | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate. lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level) |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| myocardial infarction | Cardiac disorders | Non-systematic Assessment |
| Term | Organ System | Source Vocabulary | Assessment Type | Notes | Statistical Information |
|---|---|---|---|---|---|
| hyperkalemia | Metabolism and nutrition disorders | Systematic Assessment | Hyperkalemia defined as serum potassium >5.5 mmol/L as measured at the end of the period or, for the subset of participants with chronic kidney disease stage 3 or greater or taking potassium-sparing diuretics, during week 2 of the period. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Lawrence Appel | Johns Hopkins University | 410-955-4156 | lappel@jhmi.edu |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Nov 1, 2024 | Feb 17, 2026 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003920 | Diabetes Mellitus |
| D006973 | Hypertension |
| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
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| University of Colorado, Denver |
| OTHER |
The study design is a four-period crossover feeding study, in which participants will be randomly assigned to an order of four isocaloric diets for a 5-week period each.
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The investigators and the outcomes assessors will not know which order of diets the participant has been assigned. The participant will not be explicitly told which diet he or she is receiving during each period, but by the nature of higher sodium vs. lower sodium or the differences between the DASH4D and comparison diet, the participant would likely be able to guess based on the menus and taste.
|
| comparison diet | Other | The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). |
|
| higher sodium | Other | 3700 mg/day sodium (at the 2000 kilocalorie level) |
|
| lower sodium | Other | 1500 mg/day sodium (at the 2000 kilocalorie level) |
|
| At the end of 5-week feeding period |
| At the end of 5-week feeding period |
| Fasting Glucose Level | Fasting glucose level in mg/dL. | At the end of 5-week feeding period |
| Hemoglobin A1c (HbA1c) Level | HbA1c percentage (%). | At the end of 5-week feeding period |
| Cardiovascular Disease (CVD) Risk Percentage | Current 10-year atherosclerotic cardiovascular disease (ASCVD) risk will be reported as a percent, using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD risk equation. | At the end of 5-week feeding period |
| Total Cholesterol Level | Total cholesterol level in mg/dL. | At the end of 5-week feeding period |
| Low-density Lipoprotein (LDL) Cholesterol Level | LDL cholesterol level in mg/dL. | At the end of 5-week feeding period |
| High-density Lipoprotein (HDL) Cholesterol Level | HDL cholesterol level in mg/dL. | At the end of 5-week feeding period |
| Triglyceride Level | Triglyceride level in mg/dL. | At the end of 5-week feeding period |
| Presence of Orthostatic Hypotension | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Presence of orthostatic hypotension will be defined as ≥ 20 mmHg drop in systolic blood pressure or a ≥ 10 mmHg drop in diastolic blood pressure upon standing. | At the end of 5-week feeding period |
| Postural Change in Systolic Blood Pressure | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in systolic blood pressure (mmHg) upon standing will be calculated. | At the end of 5-week feeding period |
| Postural Change in Diastolic Blood Pressure | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in diastolic blood pressure (mmHg) upon standing will be calculated. | At the end of 5-week feeding period |
| Symptoms Experienced by Participants as Assessed by a Questionnaire | Participants will complete a questionnaire about symptoms experienced while on each diet, including symptoms related to fall risk (e.g., feeling faint), food intake and output (e.g., bloating, constipation), fluid intake and output (e.g., excessive thirst), and general symptoms (e.g., fatigue or low energy). Participants will be asked to rate each listed symptom as: did not occur, mild, moderate, or severe. Score range 0-69, higher score worse symptoms. | At the end of 5-week feeding period |
| Mean Continuous Glucose Monitoring Sensor Glucose | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The mean of these glucose measurements (in mg/dL) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period. | 14-day wear period during weeks 3-5 |
| Percentage of Time Glucose Between 70 and 180 mg/dL | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 180 mg/dL (time-in-range) during 14-day wear period will be used as a primary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Glucose Coefficient of Variation (%) | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The glucose coefficient of variation (standard deviation divided by mean glucose, multiplied by 100 and expressed as a percent) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Glucose Standard Deviation | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The standard deviation of glucose measurements (in mg/dL) will be used as a secondary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Above 180 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 180 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Above 250 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 250 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Below 70 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 70 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Below 54 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 54 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Between 70 to 140 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Percentage of Time Glucose Above 140 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With >70% Time Glucose Between 70 to 180 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent >70% of time with glucose between 70 and 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With Glucose Coefficient of Variation <36% | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants with a glucose coefficient of variation <36% during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With <25% Time Glucose Above 180 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <25% of time with glucose above 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With <5% Time Glucose Above 250 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <5% of time with glucose above 250 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With <4% Time Glucose Below 70 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <4% of time with glucose below 70 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Proportion of Participants With <1% Time Glucose Below 54 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <1% of time with glucose below 54 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | At the end of 5-week feeding period |
| Comparison Diet With Lower Sodium |
|
| Comparison Diet With Higher Sodium |
|
| Participated in CGM Assessment During Second Feeding Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Comparison Diet With Lower Sodium |
|
| Comparison Diet With Higher Sodium |
|
| Participated in CGM Assessment During Third Feeding Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| Comparison Diet With Lower Sodium |
|
| Comparison Diet With Higher Sodium |
|
| Participated in CGM Assessment During Fourth Feeding Period |
|
| COMPLETED |
|
| NOT COMPLETED |
|
| years |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Ethnicity (NIH/OMB) | Count of Participants | Participants |
|
| Race (NIH/OMB) | Count of Participants | Participants |
|
| OG001 | DASH4D Diet With Higher Sodium | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate. higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level) |
| OG002 | Comparison Diet With Lower Sodium | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level) |
| OG003 | Comparison Diet With Higher Sodium | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level) |
|
|
|
| Secondary | Diastolic Blood Pressure (DBP) | After the participant has rested quietly in the seated position for at least 5 minutes, blood pressure will be measured in triplicate, using an Omron device, with each reading separated by 30 seconds, and the average of the three readings (in mmHg) will also be recorded. Blood pressure will be measured on five separate occasions during the last 2 weeks of the feeding period, and the mean diastolic blood pressure from these five blood pressures (15 total readings) will be used as a secondary outcome. | The analysis population reflects the number of participants who started the diet and completed at least one of the five blood pressure assessments during the last 2 weeks of the feeding period. | Posted | Mean | Standard Deviation | mmHg | At the end of 5-week feeding period |
|
|
|
|
| Other Pre-specified | Glycated Albumin Level | Glycated albumin percentage (%). | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Fructosamine Level | Fructosamine level in mmol/L. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Fasting Glucose Level | Fasting glucose level in mg/dL. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Hemoglobin A1c (HbA1c) Level | HbA1c percentage (%). | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Cardiovascular Disease (CVD) Risk Percentage | Current 10-year atherosclerotic cardiovascular disease (ASCVD) risk will be reported as a percent, using the American College of Cardiology (ACC)/American Heart Association (AHA) ASCVD risk equation. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Total Cholesterol Level | Total cholesterol level in mg/dL. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Low-density Lipoprotein (LDL) Cholesterol Level | LDL cholesterol level in mg/dL. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | High-density Lipoprotein (HDL) Cholesterol Level | HDL cholesterol level in mg/dL. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Triglyceride Level | Triglyceride level in mg/dL. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Presence of Orthostatic Hypotension | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Presence of orthostatic hypotension will be defined as ≥ 20 mmHg drop in systolic blood pressure or a ≥ 10 mmHg drop in diastolic blood pressure upon standing. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Postural Change in Systolic Blood Pressure | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in systolic blood pressure (mmHg) upon standing will be calculated. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Postural Change in Diastolic Blood Pressure | Participants will lie in the supine position for 5 minutes and undergo three blood pressure measurements, separated by 30 seconds. The average of these three readings will be used as the supine blood pressure. Participants will stand with their arm rested on an adjacent Mayo table at 70-80 degrees from their torso, and participants will then undergo another set of triplicate blood pressure measurements, separated by 30 seconds each. The average of these three readings will be used as the standing blood pressure. Change in diastolic blood pressure (mmHg) upon standing will be calculated. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Symptoms Experienced by Participants as Assessed by a Questionnaire | Participants will complete a questionnaire about symptoms experienced while on each diet, including symptoms related to fall risk (e.g., feeling faint), food intake and output (e.g., bloating, constipation), fluid intake and output (e.g., excessive thirst), and general symptoms (e.g., fatigue or low energy). Participants will be asked to rate each listed symptom as: did not occur, mild, moderate, or severe. Score range 0-69, higher score worse symptoms. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Mean Continuous Glucose Monitoring Sensor Glucose | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The mean of these glucose measurements (in mg/dL) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | mg/dL | 14-day wear period during weeks 3-5 |
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| Other Pre-specified | Percentage of Time Glucose Between 70 and 180 mg/dL | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 180 mg/dL (time-in-range) during 14-day wear period will be used as a primary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % time in range | At the end of 5-week feeding period |
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| Other Pre-specified | Glucose Coefficient of Variation (%) | CGM Ancillary Study Primary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The glucose coefficient of variation (standard deviation divided by mean glucose, multiplied by 100 and expressed as a percent) during the 14-day wear period will be used as a primary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % coefficient of variation | At the end of 5-week feeding period |
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| Other Pre-specified | Glucose Standard Deviation | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The standard deviation of glucose measurements (in mg/dL) will be used as a secondary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | mg/dL | At the end of 5-week feeding period |
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| Other Pre-specified | Percentage of Time Glucose Above 180 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 180 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % time above 180 mg/dL | At the end of 5-week feeding period |
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| Other Pre-specified | Percentage of Time Glucose Above 250 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 250 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % time above 250 mg/dL | At the end of 5-week feeding period |
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| Other Pre-specified | Percentage of Time Glucose Below 70 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 70 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % time below 70 mg/dL | At the end of 5-week feeding period |
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| Other Pre-specified | Percentage of Time Glucose Below 54 mg/dL | CGM Ancillary Study Secondary Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was below 54 mg/dL during the 14-day wear period will be used as a secondary outcome of the corresponding feeding period. | The analysis population for the CGM ancillary study outcomes was the 89 participants from the main trial's analytic population who completed at least one CGM outcome assessment wear period. | Posted | Mean | 95% Confidence Interval | % time below 54 mg/dL | At the end of 5-week feeding period |
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| Other Pre-specified | Percentage of Time Glucose Between 70 to 140 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was between 70 and 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Percentage of Time Glucose Above 140 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The percentage of time glucose was above 140 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With >70% Time Glucose Between 70 to 180 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent >70% of time with glucose between 70 and 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With Glucose Coefficient of Variation <36% | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants with a glucose coefficient of variation <36% during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With <25% Time Glucose Above 180 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <25% of time with glucose above 180 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With <5% Time Glucose Above 250 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <5% of time with glucose above 250 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With <4% Time Glucose Below 70 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <4% of time with glucose below 70 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| Other Pre-specified | Proportion of Participants With <1% Time Glucose Below 54 mg/dL | CGM Ancillary Study Other Outcome: Continuous glucose monitoring sensors will be worn up to 14 days during each 5-week feeding period in participants included in the DASH4D-CGM ancillary study. The proportion of participants that spent <1% of time with glucose below 54 mg/dL during the 14-day wear period will be used as an exploratory outcome of the corresponding feeding period. | Not Posted | At the end of 5-week feeding period | Participants |
| 0 |
| 92 |
| 1 |
| 92 |
| 9 |
| 92 |
| EG001 | DASH4D Diet With Higher Sodium | DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day DASH4D diet: DASH stands for "Dietary Approaches to Stop Hypertension". The DASH diet is a healthy dieter that lowers blood pressure. The DASH diet emphasizes fruits, vegetables, and low-fat dairy products; includes whole grains, poultry, fish, and nuts; and is reduced in red meat, sweets, and sugar-containing beverages. The DASH4D dietary pattern is a version of the DASH diet that is lower in carbohydrate. higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level) | 0 | 93 | 0 | 93 | 6 | 93 |
| EG002 | Comparison Diet With Lower Sodium | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). lower sodium: 1500 mg/day sodium (at the 2000 kilocalorie level) | 0 | 95 | 1 | 95 | 13 | 95 |
| EG003 | Comparison Diet With Higher Sodium | Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day comparison diet: The comparison dietary pattern is based on a typical American diet, with macronutrient distributions generally at the average of typical US intake, and micronutrient targets generally near the 25th percentile of usual US intake (with the exception of sodium). higher sodium: 3700 mg/day sodium (at the 2000 kilocalorie level) | 0 | 97 | 0 | 97 | 8 | 97 |
| EG004 | CGM Ancillary Study | Participants were offered continuous glucose monitoring (CGM). A novel systems technology recommended for assessing real-time glucose patterns, biochemical hypoglycemia, and glycemic variability. | 0 | 89 | 0 | 89 | 0 | 89 |
| decompensated heart failure | Cardiac disorders | Non-systematic Assessment |
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| hypertension escape level 2 | Cardiac disorders | Systematic Assessment | Hypertension escape level 2 defined as systolic blood pressure of 171-180 mmHg or diastolic blood pressure of 106-110 mmHg during study blood pressure assessment. |
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| hypotension | Cardiac disorders | Systematic Assessment | Hypotension defined as systolic blood pressure <90 mmHg during study blood pressure assessment. |
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| hypoglycemia | Endocrine disorders | Non-systematic Assessment | Hypoglycemia defined as self-monitored blood glucose reported as <70 mg/dL among the subset of participants taking insulin, sulfonylureas, or meglitinides. No recorded hypoglycemic events were deemed to be severe. |
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| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |