DASH Diet for High Blood Pressure

(DASH4D Trial)

Overseen By Christine Mitchell, ScM

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Johns Hopkins University

Must not be taking: Potassium supplements, Insulin, Warfarin, Corticosteroids

Disqualifiers: Type 1 diabetes, Cardiovascular disease, Cancer, Inflammatory bowel disease, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores how different diets affect blood pressure in people with type 2 diabetes. It compares a special version of the DASH diet, called the DASH4D diet, which is adjusted for diabetes, with a typical American diet for diabetics, focusing on how sodium levels in these diets impact blood pressure. Participants will try different versions of these diets, each with varying amounts of sodium, to determine which combination is most effective. People with type 2 diabetes who have consistent high blood pressure and are open to following specific meal plans might be a good fit for this trial. As an unphased trial, this study offers participants the opportunity to contribute to valuable research that could improve dietary recommendations for managing diabetes and high blood pressure.

Will I have to stop taking my current medications?

The trial requires that you have a stable dose of certain medications for at least 2 months before joining. Some medications, like potassium supplements over 99 mg/day, short-acting insulin, and certain weight loss drugs, are not allowed. It's best to discuss your specific medications with the trial team.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that the DASH4D diet, a version of the DASH diet for people with diabetes, is safe and easy to follow. Studies have found that this diet can significantly lower blood pressure, especially when combined with reduced salt intake. For example, individuals with diabetes who followed a low-salt DASH4D diet experienced a drop of about 5 points in their top blood pressure number. This indicates the diet can have a positive effect without causing harm.

The DASH diet is well-known for promoting heart health and managing blood pressure. It has a strong history of safety and effectiveness. No reports of serious side effects have emerged from following this diet, and it is generally considered safe for most people, including those with type 2 diabetes. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about the DASH4D diet for high blood pressure because it specifically tailors the DASH dietary approach for individuals with diabetes, focusing on sodium intake. Unlike standard blood pressure treatments that often rely on medications like ACE inhibitors or beta-blockers, the DASH4D diet emphasizes natural dietary adjustments. One arm of the trial explores the impact of a lower sodium intake (1500 mg/day), which is significantly less than the typical American diet, potentially offering a non-pharmaceutical way to manage blood pressure. Additionally, the trial compares this low sodium approach to a higher sodium level (3700 mg/day) to understand how sodium levels affect people with diabetes differently, potentially leading to more personalized dietary recommendations.

What evidence suggests that this trial's diets could be effective for high blood pressure?

Research has shown that the DASH4D diet can help lower blood pressure, especially with reduced salt intake. In this trial, participants will follow either the DASH4D diet with lower sodium or the DASH4D diet with higher sodium. Compared to a regular diet with more salt, the DASH4D diet with less salt lowered systolic blood pressure by an average of 4.5 points. This reduction is significant for managing high blood pressure. Designed for people with diabetes, studies have found that the diet helps them lower their blood pressure. Overall, the DASH4D diet shows promise for controlling blood pressure by promoting healthier food choices and reduced salt consumption. ^{1 3 6 7 8}

Who Is on the Research Team?

Lawrence Appel, MD, MPH

Principal Investigator

Johns Hopkins University

Hsin Chieh Yeh, PhD

Principal Investigator

Johns Hopkins University

Scott Pilla, MD, MHS

Principal Investigator

Johns Hopkins University

Elizabeth Selvin, PhD

Principal Investigator

Johns Hopkins University

Are You a Good Fit for This Trial?

Adults with Type 2 Diabetes and blood pressure between 120-159/under 100 mmHg, who can eat on-site meals regularly, have stable weight, no other clinical trials or severe illnesses. Must not be pregnant or planning pregnancy, without significant dietary restrictions that affect adherence.

Inclusion Criteria

Your diastolic blood pressure is consistently below 100 mmHg during three screening visits.

I can eat one meal a day, 3 days a week at the study site and follow the study diet.

I can video call using my own or a study-provided device.

Exclusion Criteria

Any other serious illness or condition not compatible with participation as determined by the investigators

You drink more than 14 alcoholic drinks in a week or more than 6 drinks in one sitting.

You cannot check your own blood sugar levels if necessary.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

1 visit (in-person)

Feeding Period 1

Participants are fed the DASH4D diet with lower sodium for 5 weeks

5 weeks

End-of-period visit for outcome measurement

Feeding Period 2

Participants are fed the DASH4D diet with higher sodium for 5 weeks

5 weeks

End-of-period visit for outcome measurement

Feeding Period 3

Participants are fed the comparison diet with lower sodium for 5 weeks

5 weeks

End-of-period visit for outcome measurement

Feeding Period 4

Participants are fed the comparison diet with higher sodium for 5 weeks

5 weeks

End-of-period visit for outcome measurement

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• comparison diet
• DASH4D diet
• higher sodium
• lower sodium

Trial Overview The DASH4D trial is testing the effects of a diabetes-modified DASH diet versus a typical American diet and the impact of low versus high sodium intake on blood pressure in people with Type 2 Diabetes through a controlled feeding study.

How Is the Trial Designed?

Group I: Comparison diet with higher sodium Experimental Treatment 2 Interventions

Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day

Group II: DASH4D diet with lower sodium Active Control 2 Interventions

DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day

Group III: DASH4D diet with higher sodium Active Control 2 Interventions

DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day

Group IV: Comparison diet with lower sodium Active Control 2 Interventions

Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day

Who Is Running the Clinical Trial?

Johns Hopkins University

Lead Sponsor

Trials

2,366

Recruited

15,160,000+

Sheikh Khalifa Stroke Institute at Johns Hopkins

Collaborator

Trials

1

Recruited

110+

University of Colorado - Anschutz Medical Campus

Collaborator

Trials

9

Recruited

1,700+

University of Colorado, Denver

Collaborator

Trials

1,842

Recruited

3,028,000+

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Collaborator

Trials

2,513

Recruited

4,366,000+

Sheikh Khalifa Stroke Institute

Collaborator

Trials

3

Recruited

220+

Beth Israel Deaconess Medical Center

Collaborator

Trials

872

Recruited

12,930,000+

Published Research Related to This Trial

A 2-month intervention led by a nurse practitioner for 45 overweight and obese hypertensive patients resulted in significant improvements in diet and lifestyle, as measured by standardized questionnaires.

Participants experienced an average weight loss of 3.6 pounds, indicating that the DASH diet and lifestyle changes were effective in promoting better health outcomes in this high-risk group.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Supporting cardiovascular risk reduction in overweight and obese hypertensive patients through DASH diet and lifestyle education by primary care nurse practitioners. Jarl, J., Tolentino, JC., James, K., et al.[2021]

The HF-DASH diet, which substitutes full-fat for low-fat dairy and reduces sugar intake, effectively lowers blood pressure similarly to the standard DASH diet while also reducing triglycerides and VLDL particle concentrations.

While both the DASH and HF-DASH diets lowered blood pressure, only the standard DASH diet significantly reduced LDL cholesterol and other harmful lipoproteins compared to a control diet, suggesting that the HF-DASH diet may be a safer alternative without compromising blood pressure benefits.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of the DASH (Dietary Approaches to Stop Hypertension) diet and a higher-fat DASH diet on blood pressure and lipids and lipoproteins: a randomized controlled trial. Chiu, S., Bergeron, N., Williams, PT., et al.[2023]

In a study of 2700 miners at Banovici coal mine, 25.7% were found to have arterial hypertension, highlighting a significant health concern in this population.

The average salt intake per meal for these miners ranged from 4-9 grams, exceeding the daily recommended limits set by the American College of Cardiology and American Heart Association, which could contribute to their high blood pressure rates.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of salt intake on blood pressure in banovici coal mine workers. Becarevic, M., Salihefendic, N., Zildzic, M.[2020]

In a study of 144 overweight or obese adults with high blood pressure, those following the DASH diet alone or with weight management experienced significant reductions in blood pressure compared to those on a usual diet, highlighting the diet's efficacy as a nonpharmacologic treatment.

Greater adherence to the DASH diet was linked to larger decreases in blood pressure, and the study found that African Americans had lower adherence rates, suggesting the need for culturally tailored dietary strategies to improve compliance.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Determinants and consequences of adherence to the dietary approaches to stop hypertension diet in African-American and white adults with high blood pressure: results from the ENCORE trial. Epstein, DE., Sherwood, A., Smith, PJ., et al.[2022]

The OmniHeart study is a randomized crossover trial involving 160 adults with prehypertension or Stage 1 hypertension, designed to compare the effects of a carbohydrate-rich diet with diets high in protein or unsaturated fat on blood pressure and cholesterol levels.

The study aims to provide insights into how different macronutrient compositions can influence cardiovascular risk factors, potentially guiding dietary recommendations for better heart health.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). Carey, VJ., Bishop, L., Charleston, J., et al.[2017]

The DASH diet, which emphasizes fruits, vegetables, and low-fat dairy, has been shown to effectively lower blood pressure in individuals with prehypertension and stage I hypertension, based on findings from the DASH trial.

While the DASH diet is generally safe for most patients, caution is advised for those with chronic kidney or liver diseases, and modifications may be needed for individuals with chronic heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. Tyson, CC., Nwankwo, C., Lin, PH., et al.[2021]

Citations

1. pubmed.ncbi.nlm.nih.gov pubmed.ncbi.nlm.nih.gov/40489102/

Dietary Patterns, Sodium Reduction, and Blood Pressure in ... The DASH4D diet combined with sodium reduction achieved a clinically relevant reduction in blood pressure, primarily from sodium reduction.

2. ahajournals.org ahajournals.org/doi/abs/10.1161/cir.151.suppl_1.022

Abstract 022: The Effects of Dietary Patterns and Sodium ... Compared to the comparison diet with higher sodium, the DASH4D diet with lower sodium reduced end-of-period SBP (mean Δ -4.5 mmHg, 95% CI: -7.1 ...

3. publichealth.jhu.edu publichealth.jhu.edu/2025/dash-diet-modified-for-diabetes-lowers-blood-sugar-levels-in-clinical-trial-of-adults-with-type-2-diabetes

DASH Diet Modified for Diabetes Lowers Blood Sugar Levels ... The main trial found the DASH4D diet lowered blood pressure among individuals with type 2 diabetes. Of the 89 people who completed the DASH4D ...

4. acpjournals.org acpjournals.org/doi/10.7326/ANNALS-25-03662-JC

In T2D and hypertension, the lower-sodium DASH4D diet ... In T2D and hypertension, the lower-sodium DASH4D diet reduced SBP more than a higher-sodium comparison diet at 5 wk | Annals of Internal ...

5. clinicaltrials.gov clinicaltrials.gov/study/NCT04286555

Study Details | NCT04286555 | Dietary Approaches to Stop ... 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)

6. hopkinsmedicine.org hopkinsmedicine.org/news/newsroom/news-releases/2025/06/johns-hopkins-medicine-study-finds-eating-dash-for-diabetes-lower-sodium-diet-can-produce-clinically-meaningful-reduction-in-blood-pressure-for-people-with-type-2-diabetes

Newsroom In this study, eating the low-sodium DASH4D diet lowered systolic blood pressure by about 5 additional points. In people with diabetes, a 5- ...

7. nhlbi.nih.gov nhlbi.nih.gov/education/dash-eating-plan

DASH Eating Plan | NHLBI, NIH It was named “Best Heart-Healthy Diet” and “Best Diet for High Blood Pressure” by U.S. News & World Report in 2025. Find DASH-Friendly Recipes.

8. publichealth.jhu.edu publichealth.jhu.edu/131/dash4d-a-modified-dash-diet-for-people-with-diabetes

DASH4D: A Modified DASH Diet for People with Diabetes Johns Hopkins researchers found that the DASH for Diabetes (DASH4D) diet helps people with type 2 diabetes lower blood pressure and control blood glucose.