Kidney Failure, ChronicDISaRM-HDNCT04991441
Dietary Sodium-Restriction (DIS) and Renal Meals (RM) for Hemodialysis (HD)(DISaRM-HD)
A study of Kidney Failure, Chronic and Dietary Modification, run by University of Illinois at Urbana-Champaign at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic, Dietary Modification
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2020to 31 Mar 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- not meeting above inclusion criteria 1 - 4
Trial locations and contacts
1 site in 1 country.
United States1 site, 1 recruiting
- Recruiting
University of Illinois at Urbana-Champaign
Urbana, Illinois, 61801
Kenneth R Wilund, PhD, 217-265-6755, kwilund@Illinois.edu
Alexis C King, MA, 2094185392, acking2@illinois.edu
About this study
Official title: Impact of a Low-Sodium Meal Feeding Protocol on Interdialytic Weight Gain and Markers of Cardiovascular Health in Hemodialysis Patients
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.
Read the detailed description
Chronic kidney disease patients with end-stage renal disease require regular hemodialysis (HD) therapy 3-4 days per week to filter their blood of toxins/waste and to remove excess fluid. HD therapy is essential for survival in patients with kidney failure, but the dialysis process is inefficient and does not remove all of the fluid and waste products that accumulate in patients since their last treatment. The inefficiency of dialysis, coupled with excessive dietary sodium and fluid intakes, results in a high prevalence of chronic volume overload (VO) and VO dependent hypertension (HTN). Both VO \& HTN can have adverse effects on the heart and arteries, eventually lead to enlargement of the heart and cardiac dysfunction (1-3).
Dialysis care providers (doctors, dietitians, technicians) provide regular counseling for patients to reduce their dietary sodium and fluid intake, despite widespread non-adherence and the high prevalence of both VO and hypertension. Research interventions to increase dietary education and support behavior change have also demonstrated low efficacy in the dialysis patient population. Many barriers and factors contribute to excessive dietary sodium intakes and poor dietary adherence, thus is appears that current dietary education strategies may not be robust enough to change patient behaviors. However, a recent study in heart failure patients demonstrated that home-delivered meals represent a unique opportunity alter outpatient dietary practices. Patients with multiple comorbidities and numerous dietary behaviors, such as those on renal replacement therapy, may need additional support to establish and maintain dietary changes.
The purpose of this study is to compare dietary counseling with renal home meal delivery on clinical outcomes relating to both VO \& HTN. This trial is a comparative-effectiveness mixed-models design. In this study, patients will be randomized to one of two study arms: 1) CON (7 months total) where patients receive usual care (eating their normal diet) for the first 5 months of the study. This will be followed by a 2-month period where they will receive home-delivered meals and additional dietary counseling to reduce sodium intake; OR 2) INT (5 months total), where patients will receive home-delivered meals plus additional dietary counseling for the first 2 months of the study, followed by 3 months of continued counseling. During the home-meal delivery periods, participants will be provided a low-sodium/renal diet that includes receiving 2 meals per day during their 1st month, and 1 meal per day during the 2nd month (month 6 and 7 for CON; and month 1 and 2 for INT). The meals will be delivered to the participant's homes each week by momsmeals.com.
We are also plan to collect sensory taste data to characterize patients on dialysis preferences for salt. It is possible that a low sodium diet may change these preferences, so that patients desire more low-sodium tasting food. This information would allow us to analyze how dialysis patients salt intake is associate with taste preference with salt and how this relates to clinical outcomes. The study outcomes include: clinical outcomes (hospitalizations, treatment efficiency), cardiovascular measures (blood pressure, cardiac output, and vascular resistance) and fluid/hydration status (total body water, extracellular fluid) using bioelectrical impedance.
- Conditions
- Kidney Failure, Chronic, Dietary Modification
- Being tested
- Controlled Dietary Sodium Restriction, Control Diet & Controlled Dietary Sodium Restriction
- Keywords
- Chronic Kidney Disease, Hemodialysis, Sodium Restriction
- Medical subject headings
- Kidney Failure, Chronic, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Controlled Dietary Sodium RestrictionDietary supplement
Also called INT
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
Control Diet & Controlled Dietary Sodium RestrictionDietary supplement
Also called CON
Participants will follow a Observational Control Diet (CON) diet (Months 1-5) followed by an Controlled Dietary Sodium Restriction (INT) diet (Months 6-7).
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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 Receives: Dietary Supplement: Control Diet & Controlled Dietary Sodium Restriction |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Five months
Secondary outcomes (1)
Dietary Recalls using ASA24
The research team will meet with each study participant to go over weekly nutrition education. Topics will include various activities such as reading a nutrition label, identifying 'high sodium' and 'low sodium' food content at grocery stores, introduction to 'low sodium' recipes, and cooking with alternative salt-free spices. In addition, the research team will use the Automated Self-Administered 24-hour (ASA24) Dietary Assessment Tool to assess diet recalls. The ASA24 is a web-based tool that enables multiple, automatically coded self-administered 24-hour recalls and/or multi- day food records also known as food diaries. The National Cancer Institute (NCI) provides ASA24 to the research community at no cost. Diet recalls will serve to document the change in sodium intake through the duration of the study. The sodium content (mg) of the food participants eat will be used for this outcome.
Measured: Five months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2021
- Study start1 Nov 2020
- Primary completion31 Dec 2022 (estimated)
- Study completion31 Mar 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Model description
- Sequential Assignment Observational control followed by dietary intervention
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University of Illinois at Urbana-Champaign
- Sponsor type
- University, hospital or other
- Collaborators
- Renal Research Institute
- Responsible party
- Sponsor
- Investigators
- Kenneth R Wilund, PhD, Principal investigator, University of Illinois at Urbana-Champaign
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04991441
- Sponsor's protocol ID
- 19507
- Acronym
- DISaRM-HD
- Status last verified
- Dec 2020
- First submitted
- 30 Mar 2021
- Last updated
- 5 Aug 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Study at a glance
From the registry record, last updated by the sponsor on 5 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of a Low-Sodium Meal Feeding Protocol on Interdialytic Weight Gain and Markers of Cardiovascular Health in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04991441
- Acronym / sponsor ID
- DISaRM-HD / 19507
- Conditions
- Kidney Failure, Chronic, Dietary Modification
- Keywords
- Chronic Kidney Disease, Hemodialysis, Sodium Restriction
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- University of Illinois at Urbana-ChampaignUniversity, hospital or other
- Collaborators
- Renal Research Institute
- Study start
- 1 Nov 2020 (actual)
- Primary completion
- 31 Dec 2022 (estimated)
- Study completion
- 31 Mar 2024 (estimated)
- First posted
- 5 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
Chronic kidney disease patients with end-stage renal disease require regular hemodialysis (HD) therapy 3-4 days per week to filter their blood of toxins/waste and to remove excess fluid. HD therapy is essential for survival in patients with kidney failure, but the dialysis process is inefficient and does not remove all of the fluid and waste products that accumulate in patients since their last treatment. The inefficiency of dialysis, coupled with excessive dietary sodium and fluid intakes, results in a high prevalence of chronic volume overload (VO) and VO dependent hypertension (HTN). Both VO \& HTN can have adverse effects on the heart and arteries, eventually lead to enlargement of the heart and cardiac dysfunction (1-3).
Dialysis care providers (doctors, dietitians, technicians) provide regular counseling for patients to reduce their dietary sodium and fluid intake, despite widespread non-adherence and the high prevalence of both VO and hypertension. Research interventions to increase dietary education and support behavior change have also demonstrated low efficacy in the dialysis patient population. Many barriers and factors contribute to excessive dietary sodium intakes and poor dietary adherence, thus is appears that current dietary education strategies may not be robust enough to change patient behaviors. However, a recent study in heart failure patients demonstrated that home-delivered meals represent a unique opportunity alter outpatient dietary practices. Patients with multiple comorbidities and numerous dietary behaviors, such as those on renal replacement therapy, may need additional support to establish and maintain dietary changes.
The purpose of this study is to compare dietary counseling with renal home meal delivery on clinical outcomes relating to both VO \& HTN. This trial is a comparative-effectiveness mixed-models design. In this study, patients will be randomized to one of two study arms: 1) CON (7 months total) where patients receive usual care (eating their normal diet) for the first 5 months of the study. This will be followed by a 2-month period where they will receive home-delivered meals and additional dietary counseling to reduce sodium intake; OR 2) INT (5 months total), where patients will receive home-delivered meals plus additional dietary counseling for the first 2 months of the study, followed by 3 months of continued counseling. During the home-meal delivery periods, participants will be provided a low-sodium/renal diet that includes receiving 2 meals per day during their 1st month, and 1 meal per day during the 2nd month (month 6 and 7 for CON; and month 1 and 2 for INT). The meals will be delivered to the participant's homes each week by momsmeals.com.
We are also plan to collect sensory taste data to characterize patients on dialysis preferences for salt. It is possible that a low sodium diet may change these preferences, so that patients desire more low-sodium tasting food. This information would allow us to analyze how dialysis patients salt intake is associate with taste preference with salt and how this relates to clinical outcomes. The study outcomes include: clinical outcomes (hospitalizations, treatment efficiency), cardiovascular measures (blood pressure, cardiac output, and vascular resistance) and fluid/hydration status (total body water, extracellular fluid) using bioelectrical impedance.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Sequential
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Sequential Assignment Observational control followed by dietary intervention
| Arm | Type | Receives |
|---|---|---|
| Control | Experimental | Dietary Supplement: Controlled Dietary Sodium Restriction, Dietary Supplement: Control Diet & Controlled Dietary Sodium RestrictionParticipants 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 |
| Intervention | Experimental | Dietary Supplement: Control Diet & Controlled Dietary Sodium RestrictionParticipants 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 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (1 listed)
- not meeting above inclusion criteria 1 - 4
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Controlled Dietary Sodium RestrictionAlso: INTParticipants 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 |
| Control Diet & Controlled Dietary Sodium RestrictionAlso: CONParticipants will follow a Observational Control Diet (CON) diet (Months 1-5) followed by an Controlled Dietary Sodium Restriction (INT) diet (Months 6-7). | Dietary supplement | Control, Intervention |
Primary outcome
Assessing Interdialytic weight gain (IDWG) using bioelectric impedance spectroscopy device (BIS)
Time frame: Five months
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.
Blood Pressure - markers of cardiovascular risk
Time frame: Five months
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.
1 secondary outcome
Dietary Recalls using ASA24
Time frame: Five months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Aug 2021.
- Individual participant dataSharing planned: Yes. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Kenneth R Wilund, PhD principal investigator
University of Illinois at Urbana-Champaign
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study of Kidney Failure, Chronic and Dietary Modification, run by University of Illinois at Urbana-Champaign at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 5 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alexis C King, MA (2094185392, acking2@illinois.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessing Interdialytic weight gain (IDWG) using bioelectric impedance spectroscopy device (BIS) (time frame: Five months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Aug 2021.