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

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

Interventions

DIETARY_SUPPLEMENT

Controlled Dietary Sodium Restriction

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

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

Sponsors & Collaborators

• Renal Research Institute

  collaborator OTHER

• University of Illinois at Urbana-Champaign

  lead OTHER

Principal Investigators

• Kenneth R Wilund, PhD · University of Illinois at Urbana-Champaign

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Model

SEQUENTIAL

Eligibility

Min Age

18 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2020-11-01

Primary Completion

2022-12-31

Completion

2024-03-31

Countries

• United States

Study Locations