Human Sodium Balance Study

NCT ID: NCT04110262

Last Updated: 2024-11-29

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

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

52 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-11-10

Study Completion Date

2024-08-12

Brief Summary

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The overall objective of this study is to examine how dietary sodium is used by the body. In a racially diverse sample of adults, the investigators will examine the effects of high and low dietary sodium intake on the storage and excretion of sodium and determine whether sodium distribution affects blood pressure. This has implications for how investigators interpret studies that use urine biomarkers of sodium. Study findings about tissue sodium storage also have implications for managing hypertension and related conditions.

Detailed Description

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Conditions

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Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Outcome Assessors
Throughout data collection, study data collectors and the study coordinator will remain blinded to participants' exposure group.

Study Groups

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High-low dietary sodium

High sodium diet (3400 mg/day) feeding period followed by low sodium diet (2300 mg/day) feeding period

Group Type EXPERIMENTAL

High dietary sodium intake

Intervention Type OTHER

Fourteen day feeding period of high dietary sodium (3400 mg/day)

Low dietary sodium intake

Intervention Type OTHER

Fourteen day feeding period of low dietary sodium (2300 mg/day)

Low-high dietary sodium

Low sodium diet (2300 mg/day) feeding period followed by high sodium diet (3400 mg/day) feeding period

Group Type EXPERIMENTAL

High dietary sodium intake

Intervention Type OTHER

Fourteen day feeding period of high dietary sodium (3400 mg/day)

Low dietary sodium intake

Intervention Type OTHER

Fourteen day feeding period of low dietary sodium (2300 mg/day)

Interventions

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High dietary sodium intake

Fourteen day feeding period of high dietary sodium (3400 mg/day)

Intervention Type OTHER

Low dietary sodium intake

Fourteen day feeding period of low dietary sodium (2300 mg/day)

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

* At least 18 years old;
* Diagnosed with high blood pressure or pre-hypertension (systolic blood pressure (SBP) \> 120 mm Hg or diastolic blood pressure (DBP) \> 80 mm Hg);
* Taking no more than two medications for high blood pressure;
* Currently has a primary care provider;
* Willing to eat all meals provided by the study for two 14-day feeding periods;
* Willing to complete study measurement procedures.

Exclusion Criteria

* Diabetes;
* Smoker;
* Serious food allergies;
* Currently pregnant or planning to become pregnant
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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University of California, San Diego

OTHER

Sponsor Role lead

Responsible Party

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Cheryl Anderson

Professor / Dean

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Cheryl A Anderson, PhD

Role: PRINCIPAL_INVESTIGATOR

University of California, San Diego

Locations

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University of California, San Diego

San Diego, California, United States

Site Status

Countries

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United States

Provided Documents

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Document Type: Informed Consent Form: Main consent form

View Document

Document Type: Informed Consent Form: Screening consent form

View Document

Other Identifiers

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HL140488

Identifier Type: -

Identifier Source: org_study_id