Dietary Approaches to Stop Hypertension for Diabetes

Part of paid clinical trials in Baltimore, Maryland.

Sponsor
Johns Hopkins University
Study ID
NCT04286555
Status
Completed

Conditions

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • 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.
  • 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)

Study Details

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.

Key Dates

Start date
Jun 2, 2021
Status verified
Apr 2026
Primary completion
Jun 13, 2024
Completion
Jun 17, 2024

Study Design

Enrollment
105 participants (actual)
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT

Arms

  • Active Comparator: DASH4D diet with lower sodium
    DASH-style dietary pattern, modified for people with diabetes, with sodium level of 1500 mg/day
  • Active Comparator: DASH4D diet with higher sodium
    DASH-style dietary pattern, modified for people with diabetes, with sodium level of 3700 mg/day
  • Active Comparator: Comparison diet with lower sodium
    Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 1500 mg/day
  • Other: Comparison diet with higher sodium
    Dietary pattern that is typical of what many Americans with diabetes eat, with sodium level of 3700 mg/day

Primary Outcome Measure

Systolic Blood Pressure (SBP) [ Time Frame: At the end of 5-week feeding period ]

Locations (1)

FacilityCityStateZIPSite coordinators
Johns Hopkins ProHealthBaltimoreMaryland21207-

Find similar trials in Baltimore, MD

By condition
Type 2 diabetesHypertension (high blood pressure)
By specialty
EndocrinologyMetabolic healthWeight lossCardiologyHeart disease
By research site
Johns Hopkins ProHealth· Baltimore, MD

Related Studies