Dietary Approaches to Stop Hypertension for Diabetes

Summary

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.

Conditions

• Diabetes Mellitus, Type 2
• Diabetes
• Diabetes type2
• Type2 Diabetes
• Type 2 Diabetes
• Type II Diabetes
• Hypertension
• High Blood Pressure

Interventions

OTHER

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.

OTHER

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).

OTHER

higher sodium

3700 mg/day sodium (at the 2000 kilocalorie level)

OTHER

lower sodium

1500 mg/day sodium (at the 2000 kilocalorie level)

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center

  collaborator OTHER

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

  collaborator NIH

• Sheikh Khalifa Stroke Institute at Johns Hopkins

  collaborator UNKNOWN

• University of Colorado, Denver

  collaborator OTHER

• Johns Hopkins University

  lead OTHER

Principal Investigators

• Lawrence Appel, MD, MPH · Johns Hopkins University

• Hsin Chieh Yeh, PhD · Johns Hopkins University

• Scott Pilla, MD, MHS · Johns Hopkins University

• Elizabeth Selvin, PhD · Johns Hopkins University

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

CROSSOVER

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2021-06-02

Primary Completion

2024-06-13

Completion

2024-06-17

Countries

• United States

Study Locations