Dietary Salt Intake and Vascular Function

August 28, 2013 updated by: Rhonda Bentley-Lewis, MD, Brigham and Women's Hospital
The purpose of this study is to look at the effects of high- and low-salt diets on blood vessel function in healthy subjects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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

Study Type

Interventional

Enrollment (Actual)

133

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02115
        • Brigham and Women's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 35 years (Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Male

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: High Sodium
High sodium
Dietary supplement: High sodium
Active Comparator: Low sodium
Dietary supplement: Low sodium

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
endothelial function
Time Frame: one week
one week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Brigham and Women's Hospital

Investigators

  • Principal Investigator: Rhonda Bentley-Lewis, MD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2005

Primary Completion (Actual)

November 1, 2012

Study Completion (Actual)

November 1, 2012

Study Registration Dates

First Submitted

December 28, 2007

First Submitted That Met QC Criteria

January 9, 2008

First Posted (Estimate)

January 10, 2008

Study Record Updates

Last Update Posted (Estimate)

August 29, 2013

Last Update Submitted That Met QC Criteria

August 28, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • 2004P002705

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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