Recruiting

Dietary Sodium

Sponsor:

University of Illinois at Urbana-Champaign

Code:

NCT03189758

Conditions

Kidney Failure, Chronic

Dietary Modification

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

Observational Control Diet

Controlled Dietary Sodium Restriction

Study Details

Brief summary:

Sodium-adapted magnetic resonance imaging (23Na-MRI) studies have demonstrated that sodium accumulates in certain tissues, including the skin and skeletal muscle, but may be manipulated by lifestyle factors or therapeutic interventions such as a hemodialysis (HD) session. This tissue sodium accumulation is increased with age and in the presence of certain chronic diseases such as renal failure, and may contribute to the development of high blood pressure. It currently not known what the impact of dietary sodium consumption has on tissue sodium in HD patient's and on the subsequent risk of cardiovascular complications either acutely or chronically. The University of Illinois' Biomedical Imaging Center recently completed safety testing on a 23Na-MRI coil that they modified for measuring skin and muscle sodium levels in the lower leg/calf that will be used for assessing the impact of dietary salt restriction on tissue sodium levels.

Conditions

Kidney Failure, Chronic

Dietary Modification

Study ID

NCT03189758

Start date

Jun 19, 2017

Status verified date

Jul, 2020

Completion date

Dec 31, 2021

Anticipated

Primary completion date

Dec 31, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Willingness to sign informed consent document and age 18 or greater.
  • Willingness to consume intervention meals 3 times per day (with provided snacks) for 30 days.

Exclusion Criteria:

1. Individuals with pacemakers (exclusion from cardiovascular testing only)
2. Individuals with major amputations (i.e. whole limb: foot, ankle, leg, arm)
3. Individuals with ferric metal implants or devices in the body (excluded from MRI testing only)
4. Claustrophobic individuals (excluded from MRI testing only)
5. Individuals that do not otherwise meet MRI screening requirements (mentioned below, excluded from MRI testing only)
6. Individuals on HD therapy <3 days per week or <3 months
7. Currently following a sodium restricted diet approximately <1,500 mg per day (only excluded from MRI analysis)
8. Currently diagnosed GI disorder or disease or infection

Study Design

Enrollment

20 participants

Anticipated

Intervention Model

Sequential

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: Intervention

Participants will follow a Observational Control Diet (CON) diet followed by an Controlled Dietary Sodium Restriction (INT) diet.

Interventions

Observational Control Diet

Participants will follow their usual or normal diet for 30 days (days 1-30) while under study observation.

Controlled Dietary Sodium Restriction

Participants will be provided with all meals and snacks daily, for 30 days (days 31-60). These meals should meet KDQOI guidelines for energy and protein (30-35 kcal/kg \& 1.2 g/kg) as well as low phosphorus, potassium, and sodium. The meals are formulated to less than 600-800 mg sodium each (<2,000g/day) and will be ordered and delivered through momsmeals.com

Primary outcome measure

  • Interdialytic weight gain [ Time Frame: 28 days ]
  • Tissue sodium [ Time Frame: 28 days ]

Central Contacts and Locations

Central contacts

Luis M Perez, BS

7192444805lmperez2@illinois.edu

Ken Wilund, PhD

2172656755kwilund@illinois.edu

Locations

University of Illinois at Urbana-Champaign

Recruiting

Urbana, Illinois, United States, 61801

Contacts

Ken Wilund, PhD

217-265-6755kwilund@illinois.edu

Principal Investigator:

Ken Wilund, PhD

More Information

Sponsor

University of Illinois at Urbana-Champaign

Last update posted

Aug 3, 2020

Last verified

Jul, 2020

Keywords

  • chronic kidney disease
  • hemodialysis
  • sodium restriction
  • MRI

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-09. This information was provided to ClinicalTrials.gov by University of Illinois at Urbana-Champaign on 2020-08-03.