DASH Diet for High Blood Pressure (DASH4D Trial)

Recruiting in Palo Alto (17 mi)

Overseen ByElizabeth Selvin, PhD

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Academic

Waitlist Available

Sponsor: Johns Hopkins University

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

I am 18 years old or older.

I have Type 2 diabetes with an HbA1c of 6.5% or higher, or I am on diabetes medication.

Exclusion Criteria

My kidney function is severely reduced.

I have lost or gained more than 5% of my weight in the last 2 months.

My arm's circumference is at least 50cm.

I have Type 1 diabetes.

I have not had any major heart issues or strokes in the last 6 months.

I visited the ER for asthma or COPD in the past 6 months.

I have had recent issues with my digestive system, including surgery or inflammation.

I needed help or was hospitalized for low blood sugar in the past year.

Participant Groups

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.

4Treatment groups

Experimental Treatment

Active Control

Group I: Comparison diet with higher sodiumExperimental Treatment2 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 sodiumActive Control2 Interventions

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

Group III: DASH4D diet with higher sodiumActive Control2 Interventions

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

Group IV: Comparison diet with lower sodiumActive Control2 Interventions

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