Dietary Sodium-Restriction (DIS) and Renal Meals (RM) for Hemodialysis (HD)(DISaRM-HD)

NCT04991441 | Unknown

• 1 other identifier: 19507
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief Summary

Chronic volume overload (VO) is a primary factor responsible for the excessive cardiovascular morbidity and mortality in hemodialysis (HD) patients. VO is caused in part by excessive fluid intake that is secondary to the consumption of a high salt diet. HD patients are often counselled to restrict their dietary sodium intake to help manage thirst and reduce their interdialytic weight gain (IDWG). However, data from recently published investigations demonstrate that dietary counseling alone may be ineffective. The objective of this randomized controlled trial is to determine if short-term feeding of low-sodium meals can "prime" changes in long-term nutrition behavior. It is hypothesized that feeding low-sodium meals for one month will significantly reduce IDWG and related outcomes, and continued dietary counseling and education support for 6 months will result in a sustained reduction in sodium intake upon patient resumption of meal responsibility. HD patients will be recruited and randomized to 2 groups: 1) Low-sodium meal feeding plus dietary counseling; or 2) a weight-list control group that will initially receive dietary counseling alone. IDWG will serve as the primary outcome with fluid volume overload, intradialytic hypotension, cramping, dietary sodium intake, sodium taste sensitivity and preference, and sodium self-efficacy evaluated at 1 and 6 months. This outcomes of this investigation will provide the first data on whether meal provision is an effective tool for dietary modeling and prolonged behavior change in HD patients.

Conditions

Kidney Failure, Chronic; Dietary Modification

Keywords

Chronic Kidney Disease; Hemodialysis; Sodium Restriction

Outcome Measures

Primary Outcomes (2)

• Assessing Interdialytic weight gain (IDWG) using bioelectric impedance spectroscopy device (BIS)

  The research team will assess patients hydration status by using a non-invasive Cardiac System (NICaS) bioelectric impedance spectroscopy device (BIS) that will focus on noninvasive assessment and monitoring of cardiovascular, respiratory, and fluid parameters. The system provides real-time data on various parameters of a patient's cardiac and vascular functions. NICaS is a method of Impedance Cardiography (ICG) which utilizes dual impedance electrodes (about 3''x3''), placed on two limbs, preferably one on the wrist and the other on the contralateral ankle (any combination may work). NICaS measurements include the cardiac output and its derivatives, as well as an assessment of the left ventricular cardiac contractility. This device will be used to measure fluid retention between treatments.

  Five months

• Blood Pressure - markers of cardiovascular risk

  The research team will use an IntelliSense® Blood Pressure Monitor to measure blood pressure accurately prior to dialysis treatment in quiet conditions with participants sitting rested for approximately 10 minutes. This measurement will take less than 2 minutes total to complete. The systolic blood pressure (mmHg) and diastolic blood pressure (mmHg) will be collected for this outcome.

  Five months

Secondary Outcomes (1)

• Dietary Recalls using ASA24

  Five months

Study Arms (2)

Control

EXPERIMENTAL

Participants will follow their usual or normal diet for 5 months (CON) followed by an Controlled Dietary Sodium Restriction (INT) diet for 2 months. During the sodium restricted diet, participants will be provided with 2 meals and snacks daily, for 30 days (Month 5 - days 1-30) and 1 meal and snacks daily, for 30 days (Month 6 - days 31-60). These meals should meet the National Kidney Foundation's Kidney Disease Outcomes Quality Initiative (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

Dietary Supplement: Controlled Dietary Sodium Restriction; Dietary Supplement: Control Diet & Controlled Dietary Sodium Restriction

Intervention

EXPERIMENTAL

Participants will be provided with 2 meals and snacks daily, for 30 days (days 1-30) and 1 meal 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

Dietary Supplement: Control Diet & Controlled Dietary Sodium Restriction

Interventions

Controlled Dietary Sodium Restriction DIETARY_SUPPLEMENT

Participants will be provided with 2 meals and snacks daily, for 30 days (days 1-30) and 1 meal 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

Also known as: INT

Control

Control Diet & Controlled Dietary Sodium Restriction DIETARY_SUPPLEMENT

Participants will follow a Observational Control Diet (CON) diet (Months 1-5) followed by an Controlled Dietary Sodium Restriction (INT) diet (Months 6-7).

Also known as: CON

Control; Intervention

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Willingness to sign informed consent document and age 18 or greater.
• High fluid gainer/excessive overloaded defined by: \> 3.0 % of estimated-dry weight (EDW)
• No upper or lower limb amputations. This criteria is necessary because the BIS device we are using is not able to provide accurate estimates of fluid status in participants with limb amputations.
• No pacemakers
• Willingness to consume intervention meals provided throughout the study.

Sponsors & Collaborators

• University of Illinois at Urbana-Champaign: lead
• Renal Research Institute: collaborator

Study Sites (1)

University of Illinois at Urbana-Champaign

Urbana, Illinois, 61801, United States

RECRUITING

MeSH Terms

Conditions

Kidney Failure, Chronic; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Kenneth R Wilund, PhD

  University of Illinois at Urbana-Champaign

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alexis C King, MA

CONTACT

2094185392; acking2@illinois.edu

Luis M Perez, BS

CONTACT

7192444805; lmperez@illinois.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Sequential Assignment Observational control followed by dietary intervention

Study Record Dates

• First Submitted: March 30, 2021
• First Posted: August 5, 2021
• Study Start: November 1, 2020
• Primary Completion: December 31, 2022
• Study Completion: March 31, 2024
• Last Updated: August 5, 2021

Record last verified: 2020-12

Data Sharing

• IPD Sharing: Will share
• Time Frame: The investigative team will disseminate data from this study through publication in scientific journals, as well as at academic seminars and professional conferences and meetings in the fields of nutrition and Nephrology.
• Access Criteria: The investigative team will disseminate data from this study through publication in scientific journals, as well as at academic seminars and professional conferences and meetings in the fields of nutrition and Nephrology.

Locations

US (1)