NCT02881515

Brief Summary

Excess dietary salt increases the risk for cardiovascular events, even in people that are not hypertensive. There is some evidence that excess dietary salt exaggerates blood pressure and sympathetic nervous system responses to various perturbations and increases blood pressure variability. This proposal will examine the effects of low, medium, and high salt diets on cardiovascular reactivity and blood pressure variability.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
77

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Apr 2016

Longer than P75 for not_applicable

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

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 1, 2016

Completed
5 months until next milestone

First Submitted

Initial submission to the registry

August 15, 2016

Completed
14 days until next milestone

First Posted

Study publicly available on registry

August 29, 2016

Completed
6.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 22, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 22, 2022

Completed
Last Updated

March 23, 2023

Status Verified

March 1, 2023

Enrollment Period

6.6 years

First QC Date

August 15, 2016

Last Update Submit

March 22, 2023

Conditions

Blood Pressure

Outcome Measures

Primary Outcomes (2)

  • Blood Pressure Variability

    Standard deviation of systolic blood pressure over 24 hours (mmHg)

    Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

  • Blood Pressure Reactivity - Handgrip exercise

    Change in Blood pressure during handgrip exercise (mmHg)

    Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

Secondary Outcomes (3)

  • Blood Pressure Reactivity - Cold Pressor test

    Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

  • Sympathetic Responses - Handgrip exercise

    Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

  • Sympathetic Responses - Cold Pressor test

    Day 10 of diet (i.e., after 10 days of low, medium, and high sodium diets; crossover design)

Study Arms (2)

Blood Pressure Reactivity

EXPERIMENTAL

Blood Pressure Responses to a cold pressor test and acute exercise will be assessed. This will be performed while subjects are on a low sodium diet (1000 mg/daily), medium sodium diet (2300 mg/daily), and high sodium diet (7000 mg/daily).

Other: Low Sodium DietOther: Medium Sodium DietOther: High Sodium Diet

Blood Pressure Variability

EXPERIMENTAL

Twenty four hour blood pressure variability will be assessed. This will be performed while subjects are on a low sodium diet (1000 mg/daily), medium sodium diet (2300 mg/daily), and high sodium diet (7000 mg/daily).

Other: Low Sodium DietOther: Medium Sodium DietOther: High Sodium Diet

Interventions

Low Sodium DietOTHER

Ten days of low sodium diet

Blood Pressure ReactivityBlood Pressure Variability
Medium Sodium DietOTHER

Ten days of a medium sodium diet

Blood Pressure ReactivityBlood Pressure Variability
High Sodium DietOTHER

Ten days of a high sodium diet

Blood Pressure ReactivityBlood Pressure Variability

Eligibility Criteria

Age21 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • normal blood pressure
  • men, Women, minorities
  • ECG within normal limits
  • screening blood panel within normal limits

You may not qualify if:

  • high blood pressure (\>140/90 mmHg)
  • history of cardiovascular disease
  • history of cancer
  • history of diabetes
  • history of kidney disease
  • obesity (BMI \> 30 kg/m2)
  • smoking or tobacco use
  • current pregnancy
  • nursing mothers
  • communication barriers

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Delaware

Newark, Delaware, 19716, United States

Location

Related Publications (1)

  • Migdal KU, Babcock MC, Robinson AT, Watso JC, Wenner MM, Stocker SD, Farquhar WB. The Impact of High Dietary Sodium Consumption on Blood Pressure Variability in Healthy, Young Adults. Am J Hypertens. 2020 Apr 29;33(5):422-429. doi: 10.1093/ajh/hpaa014.

    PMID: 32006422DERIVED

MeSH Terms

Interventions

Diet, Sodium-Restricted

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • William B Farquhar, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

August 15, 2016

First Posted

August 29, 2016

Study Start

April 1, 2016

Primary Completion

November 22, 2022

Study Completion

November 22, 2022

Last Updated

March 23, 2023

Record last verified: 2023-03

Locations

US(1)