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

105 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial is testing a special diet for people with diabetes and different salt levels to see how they affect blood pressure. It focuses on adults with Type 2 diabetes who have moderately high blood pressure. The goal is to find out if healthier food choices and less salt can help lower their 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 the DASH diet safe for people with high blood pressure?

The DASH diet is generally safe for most people and can be used alongside medication and other lifestyle changes. However, people with chronic kidney or liver disease, heart failure, uncontrolled diabetes, lactose intolerance, or celiac disease should consult their doctor before starting, as they may need to adjust the diet. ^{1 2 3 4 5}

How is the DASH4D diet treatment different from other treatments for high blood pressure?

The DASH4D diet is unique because it focuses on a specific eating pattern high in fruits, vegetables, and low-fat dairy, which helps lower blood pressure and cholesterol levels without medication. Unlike other treatments that may involve drugs, this diet emphasizes natural food choices to manage high blood pressure. ^{1 2 6 7 8}

What data supports the effectiveness of the DASH diet treatment for high blood pressure?

The DASH diet has been shown to lower blood pressure and bad cholesterol levels, which are important for heart health. Additionally, a similar diet with low sodium and high potassium was found to enhance the blood pressure-lowering effects of medications, especially in those on certain blood pressure drugs. ^{1 2 7 9 10}

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 cannot check your own blood sugar levels if necessary.

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

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]

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]

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]

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]

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]

Citations

1. United States pubmed.ncbi.nlm.nih.gov

Associations Between Dietary Patterns and Subclinical Cardiac Injury: An Observational Analysis From the DASH Trial. [2021]

2. England pubmed.ncbi.nlm.nih.gov

Influence of dietary modifications on the blood pressure response to antihypertensive medication. [2011]

3. United States 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. [2021]

4. United States 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. [2022]

5. England pubmed.ncbi.nlm.nih.gov

Rationale and design of the Optimal Macro-Nutrient Intake Heart Trial to Prevent Heart Disease (OMNI-Heart). [2017]

6. Bosnia and Herzegovina pubmed.ncbi.nlm.nih.gov

Effects of salt intake on blood pressure in banovici coal mine workers. [2020]

7. United States pubmed.ncbi.nlm.nih.gov

The Dietary Approaches to Stop Hypertension (DASH) eating pattern in special populations. [2021]

8. United States pubmed.ncbi.nlm.nih.gov

The effect of dietary patterns on estimated coronary heart disease risk: results from the Dietary Approaches to Stop Hypertension (DASH) trial. [2021]

9. United States 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. [2023]

10. United States pubmed.ncbi.nlm.nih.gov

Effects of the DASH diet alone and in combination with exercise and weight loss on blood pressure and cardiovascular biomarkers in men and women with high blood pressure: the ENCORE study. [2022]