Human Sodium Balance Study (MEASURE)

University of California San Diego

Status: Completed

Conditions: Hypertension

Treatments: Other: Low dietary sodium intake; Other: High dietary sodium intake

Study type: Interventional

Funder types: Other

Identifiers

NCT04110262

HL140488

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18 to 69 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

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52 participants in 2 patient groups

High-low dietary sodium

Experimental group

Description:

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

Treatment:

Other: High dietary sodium intake

Other: Low dietary sodium intake

Low-high dietary sodium

Experimental group

Description:

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

Treatment:

Other: High dietary sodium intake

Other: Low dietary sodium intake