Dietary Salt Intake and Vascular Function

Early Phase 1

Completed

• Conditions: Healthy
• Interventions: Dietary Supplement: High sodium; Dietary Supplement: Low sodium

• Registration Number: NCT00590512
• Lead Sponsor: Brigham and Women's Hospital

Brief Summary

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

Detailed Description

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

Study Timeline

• Study Start: 2005-03
• Study First Submitted: 2007-12-28
• Study First Submitted QC: 2008-01-09
• Study First Posted: 2008-01-10
• Primary Completion: 2012-11
• Study Completion: 2012-11
• Status Verified: 2013-08
• Last Update Submitted: 2013-08-28
• Last Update Posted: 2013-08-29

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Male
• Target Recruitment: 133

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
High Sodium	High sodium	High sodium
Low sodium	Low sodium	Low sodium

Primary Outcome Measures

Name	Time	Method
endothelial function	one week

Trial Locations

Locations (1)

Brigham and Women's Hospital; 🇺🇸 Boston, Massachusetts, United States