Dietary Salt Intake and Vascular Function

Mass General Brigham

Status and phase: Completed; Early Phase 1

Conditions: Healthy

Treatments: Dietary Supplement: Low sodium; Dietary Supplement: High sodium

Study type: Interventional

Funder types: Other

Identifiers

NCT00590512

2004P002705

Details and patient eligibility

About

The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Full description

Healthy volunteers will be enrolled in a dietary sodium intervention to examine impact on vascular function.

Enrollment: 133 patients

Sex: Male

Ages: 18 to 35 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Healthy male, African-American volunteers
2. 18-35 years of age,
3. No personal or first degree relative with hypertension or diabetes,
4. Blood pressure <130/85 mmHg and > 90/60 at the screening visit,
5. Body mass index <30 kg/m2,
6. No clinically significant abnormalities on screening tests (complete blood count, serum electrolytes, liver enzymes, thyroid stimulating hormone, urinalysis and electrocardiogram).

Exclusion criteria

1. Alcohol intake >2 beverage/night,
2. Smoking,
3. Recreational drug use,
4. Personal history of coronary disease, diabetes, hypertension, stroke, kidney disease, or illness requiring overnight hospitalization in the past 6 months,
5. Prescription or herbal medication use,
6. Ischemic changes on resting electrocardiogram,
7. Known hypersensitivity to any of the study drugs,
8. Other active medical problems detected by examination or laboratory testing.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Double Blind

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133 participants in 2 patient groups

High Sodium

Active Comparator group

Description:

High sodium

Treatment:

Dietary Supplement: High sodium

Low sodium

Active Comparator group

Description:

Low sodium

Treatment:

Dietary Supplement: Low sodium