Prepared Meals to Prime and Perpetuate Reduced Dietary Sodium Intake in Hemodialysis (PEPPERDISH)

This is a randomized clinical trial in which maintenance hemodialysis patients will be provided with salt restricted 'dialysis friendly' meals and compared to a control arm receiving usual care.

Study Overview

• Status: Completed
• Conditions: Hypertension in Dialysis Patients; Fluid Overload in Dialysis Patients
• Intervention / Treatment: Other: Sodium Restricted Meals; Other: Control

Detailed Description

Patients randomized to the intervention arm will receive 2 months of meals plus dietary counseling. Counseling will continue for an additional 3 months while the control arm will have 5 months of usual care followed by 2 months of meal provision. Effects on interdialytic weight gain, achievement of target dry weight, intradialytic hypotension episodes, blood pressure, and a volume assessment using lung U/S to assess lung water will be measured. Salt sensitivity will be tested throughout the study. Self reported questionnaires about the burden of adhering to the low salt diet and the level of adherence with it will be completed at baseline and throughout the study. The investigator hypothesizes that the prepared meals with prime patients behavior and may alter salt taste perception and that these effects will be sustained after the prepared meals have stopped.

• Study Type: Interventional
• Enrollment (Actual): 40
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Massachusetts
    • Boston, Massachusetts, United States, 02111
      • Tufts Medical Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

1. Age >18
2. Treated with outpatient hemodialysis for >60 days
3. Mean IDWG over the past 30 days >2 kg
4. Speaks and understands English or Chinese
5. Patient has a freezer at home with space to store at least 7 prepared meals
6. Cognitively intact (able to provide informed consent and answer questionnaires)

Exclusion Criteria:

-

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Sequential Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Intervention; The experimental arm receives 2 months of sodium restricted prepared meals plus dietary counseling followed by 3 months of counseling alone.	Other: Sodium Restricted Meals; 2 meals prepared with 2 g /day sodium restriction and adhering to dietary recommendations for a hemodialysis patients (phosphate and potassium restricted/ high protein content) 2 meals per day for first month of meal provision period followed by 1 meal per month in the second meal of meal provision period; Other Names: Dietary Counseling
Placebo Comparator: Control; The control arm receives 5 months of usual care followed by 2 months of receipt of sodium restricted prepared meals.	Other: Control; Usual Care

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in Interdialytic Weight Gain throughout Length of Study	A standard measurement taken for HD patients at each dialysis session to see weight gained between sessions	Every two weeks starting through 5months (intervention arm)/ 7 months (control arm)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Rate of Intradialytic Hypotension Episodes throughout Length of Study	Intradialytic Systolic BP <90 mm Hg	Every two weeks starting at baseline and through 5months (Control Arm)/ 7 months (intervention arm)

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Pre-dialysis Blood Pressure	BP measurement prior to dialysis, taken for HD patients at each session	through 5months (intervention arm)/ 7 months (control arm)
Salt Taste Perception	Testing salty solution taste perception via sip, swish, and spit and rating saltiness on a general Labeled Magnitude Scale ranging from "Barely Detectable" to "Strongest Imaginable".	through 5months (intervention arm)/ 7 months (control arm)
Salt Taste Preference	Testing salty solution taste preference via sip, swish, and spit and, in the opinion of the participant, selecting which solution tasted better.	through 5months (intervention arm)/ 7 months (control arm)
Fluid Overload	As defined by lung U/S at the end of the dialysis treatment	through 5months (intervention arm)/ 7 months (control arm)
Rate of Achievement of Estimated Dry Weight	Post-weight not greater than EDW by 0.5 kg	through 5months (intervention arm)/ 7 months (control arm)

Collaborators and Investigators

• Sponsor: Tufts Medical Center

Study record dates

Study Major Dates

• Study Start (Actual): June 5, 2019
• Primary Completion (Actual): December 31, 2021
• Study Completion (Actual): December 31, 2021

Study Registration Dates

• First Submitted: February 4, 2019
• First Submitted That Met QC Criteria: June 17, 2019
• First Posted (Actual): June 18, 2019

Study Record Updates

• Last Update Posted (Actual): January 18, 2023
• Last Update Submitted That Met QC Criteria: January 17, 2023
• Last Verified: January 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Hypertension
• Other Study ID Numbers: 999

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No