Visualizing Vascular Mechanisms of Salt Sensitivity

NCT03696433 | Completed Results

• 1 other identifier: 181610
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess the salt sensitive blood pressure response to dietary salt load compared with radiological markers of salt handling.

Conditions

Obesity; Cardiovascular Risk Factor; Salt; Excess

Keywords

salt sensitive, blood pressure, obesity, magnetic resonance imaging

Outcome Measures

Primary Outcomes (1)

• Mean Arterial Blood Pressure Following High-salt Diet and Low-salt Diet

  Mean arterial pressure following high-salt diet, and low-salt diet.

  Following completion of all dietary supplements and washout, in no less than 21 days.

Study Arms (2)

Low- then high-salt diet

EXPERIMENTAL

10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: low-salt diet, then washout consisting of the subject's typical diet, then high-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.

Dietary Supplement: Low-salt diet; Dietary Supplement: High-salt diet

High- then low-salt diet

EXPERIMENTAL

10 subjects will be enrolled and each will undergo study procedures at 4 separate visits. Subjects will be randomly assigned to this study arm, differing in the order of low and high salt diets. After a baseline visit to include a noninvasive MRI scan, the subject will begin this study diet: high-salt diet, then washout consisting of the subject's typical diet, then low-salt diet. Each dietary or washout period lasts for 7 days, and study visits will occur after each period.

Dietary Supplement: Low-salt diet; Dietary Supplement: High-salt diet

Interventions

Low-salt diet DIETARY_SUPPLEMENT

The low-salt diet (7 days) will consist of meals, snacks and water provided by Vanderbilt's metabolic kitchen.

High- then low-salt diet; Low- then high-salt diet

High-salt diet DIETARY_SUPPLEMENT

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

High- then low-salt diet; Low- then high-salt diet

Eligibility Criteria

• Age: 18 Years - 55 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• Identification as black race
• Age between 18 and 55 years
• Body mass index between 25 and \<35 kg/m2
• Normotensive or pre-hypertensive
• Willing to adhere to study diets
• Able to provide informed consent and communicate with study personnel

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, or use of hormone replacement therapy or oral contraceptive
• Current steroid use
• Contraindications to MRI
• Active infection or open wounds on the top of the feet or hands

Sponsors & Collaborators

• Vanderbilt University Medical Center: lead

Study Sites (1)

Vanderbilt University Medical Center

Nashville, Tennessee, 37212, United States

Location

Related Publications (2)

• Crescenzi R, Marton A, Donahue PMC, Mahany HB, Lants SK, Wang P, Beckman JA, Donahue MJ, Titze J. Tissue Sodium Content is Elevated in the Skin and Subcutaneous Adipose Tissue in Women with Lipedema. Obesity (Silver Spring). 2018 Feb;26(2):310-317. doi: 10.1002/oby.22090. Epub 2017 Dec 27.

  PMID: 29280322 BACKGROUND

• Crescenzi R, Donahue PMC, Hartley KG, Desai AA, Scott AO, Braxton V, Mahany H, Lants SK, Donahue MJ. Lymphedema evaluation using noninvasive 3T MR lymphangiography. J Magn Reson Imaging. 2017 Nov;46(5):1349-1360. doi: 10.1002/jmri.25670. Epub 2017 Feb 28.

  PMID: 28245075 BACKGROUND

MeSH Terms

Conditions

Obesity

Interventions

Diet, Sodium-Restricted

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Diet Therapy; Nutrition Therapy; Therapeutics; Diet; Nutritional Physiological Phenomena; Diet, Food, and Nutrition; Physiological Phenomena

Results Point of Contact

• Title: Cassandra Reynolds, BS, CCRC
• Organization: Vanderbilt University Medical Center

cassandra.f.reynolds@vumc.org

615-875-9854

Study Officials

• Rachelle Crescenzi, PhD

  Department of Radiology, Vanderbilt University Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: September 25, 2018
• First Posted: October 4, 2018
• Study Start: February 1, 2019
• Primary Completion: November 4, 2022
• Study Completion: November 4, 2022
• Last Updated: April 23, 2026
• Results First Posted: January 15, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share

Locations

US (1)