NCT04110262

Brief Summary

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
52

participants targeted

Target at P25-P50 for not_applicable hypertension

Timeline
Completed

Started Nov 2021

Typical duration for not_applicable hypertension

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

August 23, 2019

Completed
1 month until next milestone

First Posted

Study publicly available on registry

October 1, 2019

Completed
2.1 years until next milestone

Study Start

First participant enrolled

November 10, 2021

Completed
2.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 12, 2024

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 12, 2024

Completed
Last Updated

November 29, 2024

Status Verified

November 1, 2024

Enrollment Period

2.8 years

First QC Date

August 23, 2019

Last Update Submit

November 26, 2024

Conditions

Hypertension

Keywords

Blood pressureSodiumSaltRandomized controlled trialbalancehumans

Outcome Measures

Primary Outcomes (4)

  • Estimated sodium concentration in skin and muscle

    The concentration of sodium in skin and muscle will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Skin and muscle sodium stores will be non-invasively quantified using 23sodium-magnetic resonance imaging (23Na-MRI).

    60 days

  • Estimated sodium concentration in bone

    The concentration of sodium in bone will be measured, and the difference in concentrations resulting from high versus low sodium intakes will be calculated. Sodium storage in bone will be measured non-invasively using in vivo neutron activation analysis (IVNAA) technology to quantify the concentration of Na in the hand.

    60 days

  • Concentration of sodium, potassium, and hormone regulators in excreted urine

    Urinary concentration of sodium, potassium, and hormones (renin, angiotensin, aldosterone, free cortisol, free cortisone, glucocorticoid, and mineralocorticoid) will be measured and variation over time will be calculated.

    60 days

  • Blood pressure

    Blood pressure under high versus low dietary sodium conditions will be measured.

    60 days

Secondary Outcomes (2)

  • Racial differences in concentrations of sodium in skin, muscle and bone

    60 days

  • Racial differences in concentration of urinary potassium excretion

    60 days

Study Arms (2)

High-low dietary sodium

EXPERIMENTAL

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

Other: High dietary sodium intakeOther: Low dietary sodium intake

Low-high dietary sodium

EXPERIMENTAL

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

Other: High dietary sodium intakeOther: Low dietary sodium intake

Interventions

High dietary sodium intakeOTHER

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

High-low dietary sodiumLow-high dietary sodium
Low dietary sodium intakeOTHER

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

High-low dietary sodiumLow-high dietary sodium

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Diabetes;
  • Smoker;
  • Serious food allergies;
  • Currently pregnant or planning to become pregnant

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of California, San Diego

San Diego, California, 92093, United States

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Cheryl A Anderson, PhD

    University of California, San Diego

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
Throughout data collection, study data collectors and the study coordinator will remain blinded to participants' exposure group.
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Model Details: Dietary intervention consisting of two 25-day feeding periods separated by a 10-day washout.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor / Dean

Study Record Dates

First Submitted

August 23, 2019

First Posted

October 1, 2019

Study Start

November 10, 2021

Primary Completion

August 12, 2024

Study Completion

August 12, 2024

Last Updated

November 29, 2024

Record last verified: 2024-11

Locations

US(1)