NCT03564262

Brief Summary

Americans eat more salt than is recommended by the American Heart Association. This is important because consuming a high-salt diet is associated with an increased risk of cardiovascular events, like strokes and heart attacks. In fact, consuming one high-salt meal temporarily reduces blood vessel function and it is not uncommon for Americans to consume high-salt meals. Therefore, our laboratory is interested in determining if a single high-salt meal affects 1) brain blood vessel function at rest and 2) blood pressure responses during exercise.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
37

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started May 2018

Typical duration 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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 1, 2018

Completed
15 days until next milestone

First Submitted

Initial submission to the registry

May 16, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 20, 2018

Completed
2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2020

Completed
Last Updated

September 22, 2020

Status Verified

September 1, 2020

Enrollment Period

2.1 years

First QC Date

May 16, 2018

Last Update Submit

September 18, 2020

Conditions

Blood PressureCerebrovascular Reactivity

Outcome Measures

Primary Outcomes (2)

  • Change from Baseline Cerebrovascular Reactivity post soup consumption

    Middle Cerebral Artery/ End-tidal Carbon Dioxide (cm/s/mmHg)

    Prior to and 60 minutes after soup consumption

  • Blood Pressure Reactivity- Dynamic Exercise

    Change in Blood Pressure during dynamic exercise (mmHg)

    80 minutes after soup consumption

Study Arms (2)

Cerebrovascular Reactivity

EXPERIMENTAL

Cerebrovascular reactivity (CVR) will be assessed using transcranial Doppler ultrasound with carbon dioxide as the vasoactive stimuli. The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order. The CVR test will be performed prior to soup consumption as well as after soup consumption.

Other: Low Sodium Meal (138 mg sodium)Other: High Sodium Meal (1,495 mg sodium)

Blood Pressure Reactivity

EXPERIMENTAL

Blood pressure responses during dynamic exercise will be assessed. The intervention is to provide subjects with either a low sodium meal (138 mg sodium) and high sodium meal (1,495 mg sodium), in a randomized order. Blood pressure reactivity during dynamic exercise will be assessed after soup consumption.

Other: Low Sodium Meal (138 mg sodium)Other: High Sodium Meal (1,495 mg sodium)

Interventions

Low Sodium Meal (138 mg sodium)OTHER

One Low Sodium Meal

Blood Pressure ReactivityCerebrovascular Reactivity
High Sodium Meal (1,495 mg sodium)OTHER

One High Sodium Meal

Blood Pressure ReactivityCerebrovascular Reactivity

Eligibility Criteria

Age18 Years - 45 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • normal blood pressure
  • males, females, minorities

You may not qualify if:

  • high blood pressure
  • body mass index (BMI \> 30 kg/m2)
  • smokers or nicotine users
  • those who are pregnant or planning to become pregnant
  • allergy to the tomato soup

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

William B Farquhar

Newark, Delaware, 19713, United States

Location

Related Publications (1)

  • Migdal KU, Robinson AT, Watso JC, Babcock MC, Serrador JM, Farquhar WB. A high-salt meal does not augment blood pressure responses during maximal exercise. Appl Physiol Nutr Metab. 2020 Feb;45(2):123-128. doi: 10.1139/apnm-2019-0217. Epub 2019 Jun 25.

    PMID: 31238011RESULT

MeSH Terms

Interventions

Sodium

Intervention Hierarchy (Ancestors)

Metals, AlkaliElementsInorganic ChemicalsMetals, LightMetals

Study Officials

  • William B Farquhar, PhD

    University of Delaware

    PRINCIPAL INVESTIGATOR

  • Kamila U Migdal, BS

    University of Delaware

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

May 16, 2018

First Posted

June 20, 2018

Study Start

May 1, 2018

Primary Completion

June 1, 2020

Study Completion

June 1, 2020

Last Updated

September 22, 2020

Record last verified: 2020-09

Locations

US(1)