Dietary Salt Intake and Vascular Function

NCT ID: NCT00590512

Last Updated: 2013-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

COMPLETED

Clinical Phase

EARLY_PHASE1

Total Enrollment

133 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-03-31

Study Completion Date

2012-11-30

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Healthy

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

dietary salt sodium blood vessels vascular function endothelial function heart disease risk cardiovascular disease risk

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

DOUBLE

Caregivers Outcome Assessors

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

High Sodium

High sodium

Group Type ACTIVE_COMPARATOR

High sodium

Intervention Type DIETARY_SUPPLEMENT

Low sodium

Low sodium

Group Type ACTIVE_COMPARATOR

Low sodium

Intervention Type DIETARY_SUPPLEMENT

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

High sodium

Intervention Type DIETARY_SUPPLEMENT

Low sodium

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

MALE

Accepts Healthy Volunteers

Yes

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Brigham and Women's Hospital

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Rhonda Bentley-Lewis, MD

Assistant Professor of Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Rhonda Bentley-Lewis, MD

Role: PRINCIPAL_INVESTIGATOR

Massachusetts General Hospital

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

Brigham and Women's Hospital

Boston, Massachusetts, United States

Site Status

Countries

Review the countries where the study has at least one active or historical site.

United States

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

2004P002705

Identifier Type: -

Identifier Source: org_study_id