NCT02730780

Brief Summary

This study aims to assess the natriuretic peptide response to dietary salt loading in African-American individuals compared with white individuals.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
60

participants targeted

Target at P50-P75 for not_applicable healthy

Timeline
Completed

Started Jul 2016

Longer than P75 for not_applicable healthy

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

First Submitted

Initial submission to the registry

March 29, 2016

Completed
8 days until next milestone

First Posted

Study publicly available on registry

April 6, 2016

Completed
4 months until next milestone

Study Start

First participant enrolled

July 22, 2016

Completed
4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 20, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

May 20, 2021

Completed
Last Updated

November 9, 2022

Status Verified

November 1, 2022

Enrollment Period

4.8 years

First QC Date

March 29, 2016

Last Update Submit

November 8, 2022

Conditions

HealthyPrehypertension

Outcome Measures

Primary Outcomes (1)

  • The difference in circulating NT-proANP levels in response to low and high dietary salt.

    4 years

Secondary Outcomes (7)

  • Tissue sodium content

    4 years

  • Blood pressure

    4 years

  • Salt-sensitive hypertension

    4 years

  • Urinary sodium excretion

    4 years

  • Myocardial early relaxation velocities

    4 years

  • +2 more secondary outcomes

Study Arms (2)

African-American

OTHER

40 healthy African-American subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days.

Dietary Supplement: Low-Salt DietDietary Supplement: High-Salt Diet

Whites

OTHER

40 healthy white subjects will be enrolled and each will undergo study procedures at 4 separate visits, with each visit occurring 7-days apart. After a baseline visit, the subject will begin either a low-salt or high-salt diet, based upon randomization assignment to one of the two following dietary protocols: A) low-salt diet, washout, then high-salt diet; or B) high-salt diet, washout, then low-salt diet. Each dietary or washout period lasts for 7 days.

Dietary Supplement: Low-Salt DietDietary Supplement: High-Salt Diet

Interventions

Low-Salt DietDIETARY_SUPPLEMENT

The low-salt diet (7 days) will consist of meals, snacks, and sodium free water provided by the study staff.

African-AmericanWhites
High-Salt DietDIETARY_SUPPLEMENT

The high-salt diet (7 days) consists of each subject's usual diet, supplemented each day with 2 bouillon broth packets, which will be provided to the subject by the study staff.

African-AmericanWhites

Eligibility Criteria

Age18 Years - 55 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • age between 18 and 55 years
  • BMI between 18 and \<25 kg/m2
  • normotensive or pre-hypertensive
  • willing to adhere to study diets

You may not qualify if:

  • prevalent cardiovascular disease or use of medications for cardiovascular disease
  • Current or prior history of hypertension or use of blood pressure lowering medications
  • Current or prior history of diabetes mellitus or use of anti-diabetic medications
  • Prevalent renal disease (eGFR \< 60 ml/min/1.73m2), abnormal serum sodium or potassium
  • Current or prior smoker
  • Current pregnancy
  • Current steroid use
  • Contraindications to MRI

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Vanderbilt Univeristy

Nashville, Tennessee, 37203, United States

Location

Related Publications (2)

  • Gupta DK, de Lemos JA, Ayers CR, Berry JD, Wang TJ. Racial Differences in Natriuretic Peptide Levels: The Dallas Heart Study. JACC Heart Fail. 2015 Jul;3(7):513-519. doi: 10.1016/j.jchf.2015.02.008. Epub 2015 Jun 10.

    PMID: 26071618BACKGROUND

  • Gupta DK, Claggett B, Wells Q, Cheng S, Li M, Maruthur N, Selvin E, Coresh J, Konety S, Butler KR, Mosley T, Boerwinkle E, Hoogeveen R, Ballantyne CM, Solomon SD. Racial differences in circulating natriuretic peptide levels: the atherosclerosis risk in communities study. J Am Heart Assoc. 2015 May 21;4(5):e001831. doi: 10.1161/JAHA.115.001831.

    PMID: 25999400BACKGROUND

MeSH Terms

Conditions

Prehypertension

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Intervention Hierarchy (Ancestors)

Diet TherapyNutrition TherapyTherapeuticsDietNutritional Physiological PhenomenaDiet, Food, and NutritionPhysiological Phenomena

Study Officials

  • Deepak K Gupta, MD

    Vanderbilt Cardiovascular Medicine

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
HEALTH SERVICES RESEARCH
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

March 29, 2016

First Posted

April 6, 2016

Study Start

July 22, 2016

Primary Completion

May 20, 2021

Study Completion

May 20, 2021

Last Updated

November 9, 2022

Record last verified: 2022-11

Data Sharing

IPD Sharing
Will share

Locations

US(1)