HyperkalemiaNCT05086185
Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients
An observational study of Hyperkalemia and Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Nevada, Reno at 1 site in United States.
Trial summary
High blood potassium levels (hyperkalemia) is a major problem for people with kidney failure undergoing hemodialysis treatment. In order to reduce the risk of hyperkalemia, people with kidney failure are advised to limit or avoid high-potassium foods. Read more about this study
- Who is it for?
- Ages 18 to 89 years
- Conditions the study is for
- Hyperkalemia, Chronic Kidney Disease Requiring Chronic Dialysis
- What is being tested?
- Kalemic Response to Orange Juice and Kalemic Response to Orange Juice with Fiber
- How many people
- 7 participants
- Where
- 1 siteUnited States
- Study dates
- 29 Jun 2021to 5 Oct 2023
- Phase
- Observational
- 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 to 89 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: The source population for this intervention will be adults (18-89 years) with kidney failure undergoing thrice-weekly maintenance hemodialysis treatment
Who may be able to join
- Kidney failure undergoing thrice-weekly maintenance hemodialysis
- 10 patients without diabetes mellitus, and 10 patients with type 2 diabetes mellitus (T2D) that are being managed with lifestyle and/or long-acting insulin
Who cannot join
- Moderate hyperkalemia (>6.5 mEq/L) in the last 6-months.
- Potassium-lowering medications
- Gastrointestinal (GI) diseases that may alter potassium digestion and absorption.
- Low hemoglobin concentrations (<10.0 g/dL).
- Deemed to be inappropriate for the intervention by Study Nephrologist based on cognition, prognosis, or pending treatments
- Women who are pregnant or who plan to become pregnant
Trial locations and contacts
1 site in 1 country.
About this study
High blood potassium levels (hyperkalemia) is a major problem for people with kidney failure undergoing hemodialysis treatment. In order to reduce the risk of hyperkalemia, people with kidney failure are advised to limit or avoid high-potassium foods. However, high-potassium foods comprise many healthy food choices, including commonly consumed fruits and vegetables that are key sources of dietary fiber, and other important nutrients.
Risk of hyperkalemia from dietary potassium intake is most notable in the first few hours after a meal when ingested potassium enters the bloodstream. In general, dietary potassium is very well absorbed. However, dietary fiber has been shown to increase the proportion of dietary potassium that is excreted in stool. Based on these findings, it has been proposed that fiber may help to lower the risk of hyperkalemia in people with kidney disease. It remains unclear whether dietary fiber increases potassium excretion in stool by reducing the absorption of dietary potassium, or by drawing body potassium into the bowels by increasing stool bulk. The distinction may be important, as reducing potassium absorption would be expected to be of greater benefit in preventing hyperkalemia caused by eating high-potassium foods.
In this study, the investigators will assess whether a fiber supplement can reduce the effect of dietary potassium from orange juice on blood potassium levels in people with kidney disease undergoing maintenance hemodialysis treatment.
Read the detailed description
The source population for this study will be adults (18-89 years old) with kidney failure undergoing thrice weekly maintenance hemodialysis (HD) treatment. Participants will include 10 patients without diabetes mellitus, and 10 patients with type 2 diabetes mellitus (T2D) that is being managed with lifestyle with or without long-acting insulin. Patients with a moderate hyperkalemia (>6.5 mEq/L) in the last 6-months, taking potassium-lowering medications, having gastrointestinal (GI) disorders that may alter potassium digestion and absorption, and low hemoglobin concentrations (<10.0 g/dL) will be excluded. In addition, participants who are deemed inappropriate for the intervention by the study Nephrologist based on cognition, prognosis or pending treatments will be excluded.
Once enrolled, participants will be asked to complete questionnaires on demographics, dietary intake, GI symptoms, and urine output. In addition, baseline data on anthropometrics, physical function, medical history and blood parameters will be obtained by physical exam and review of medical records.
Treatment measurement visits will be conducted on the same non-dialysis treatment days at the University of Nevada, Reno Clinical Research Center with participants in a fasted state. Serial blood samples will be collected before, and 60, 120 and 180 minutes after ingesting orange juice providing 0.35 mEq/kg dose of potassium alone, or with 0.15 g/kg of psyllium-based fiber. The sequence of treatments (1) orange juice or 2) orange juice + fiber) will be randomly assigned with equal allocation by T2D status. If a participant's body weight exceeds 120% of ideal body weight (IBW), then the dose of orange juice and fiber will be based on adjusted body weight.
Blood tests at times 0 and 60-minutes post-treatment will be analyzed for the basic metabolic panel plus insulin, and the 120- and 180-minutes blood samples will be analyzed for potassium concentrations. The kalemic response to study treatments will assessed based on: 1) peak change in plasma potassium concentrations, and 2) total area under the curve for plasma potassium until 180-minutes. These parameters will be compared across treatment conditions using paired t-test. If non-normally distributed, values will be log-transformed prior to analyses.
- Being tested
- Kalemic Response to Orange Juice, Kalemic Response to Orange Juice with Fiber
- Keywords
- Hyperkalemia, Hemodialysis, Chronic kidney disease, Dietary fiber
- Medical subject headings
- Hyperkalemia, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Kalemic Response to Orange JuiceDiagnostic test
100% pulp-free orange juice
Kalemic Response to Orange Juice with FiberDietary supplement
100% pulp-free orange juice with psyllium-based fiber added
| Study group | Role | What they receive |
|---|---|---|
| Orange Juice (control) | Orange juice providing a 0.35 mEq/kg dose of potassium Receives: Diagnostic Test: Kalemic Response to Orange Juice | |
| Orange Juice plus Fiber | Same amount of orange juice as Orange Juice treatment with 0.15 g/kg of psyllium-based fiber added Receives: Dietary Supplement: Kalemic Response to Orange Juice with Fiber |
What is being measured
The primary outcome is the main question the study is designed to answer.
Peak change in plasma potassium levels
The kalemic response to study treatments will be assessed based on peak change in plasma potassium concentrations compared to pre-treatment.
Measured: 0 to 180-minutes
Plasma potassium area under the curve
The kalemic response to study treatments will be assessed based on total area under the curve for plasma potassium concentrations from pre-treatment to 180-minutes.
Measured: 0 to 180-minutes
Secondary outcomes (2)
Peak change in plasma potassium levels by diabetes status
The kalemic response to study treatments (Primary Outcome 1) will be compared between participants with and without type 2 diabetes mellitus.
Measured: 0 to 180-minutes
Plasma potassium area under the curve by diabetes status
The kalemic response to study treatments (Primary Outcome 2) will be compared between participants with and without type 2 diabetes mellitus.
Measured: 0 to 180-minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Oct 2021
- Study start29 Jun 2021
- Primary completion5 Oct 2023
- Study completion5 Oct 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for HyperkalemiaStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 7 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Nevada, Reno
- Sponsor type
- University, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Sierra Nevada Nephrology Consultants, Inc.
- Responsible party
- Sponsor
- Investigators
- David E St-jules, PhD, Principal investigator, University of Nevada, Reno
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05086185
- Sponsor's protocol ID
- 1596754
- Status last verified
- Mar 2025
- First submitted
- 12 Jul 2021
- Last updated
- 27 Mar 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: The IPD will be available after being unidentified to those who will contact the principal investigator for research purposes.
Publications
St-Jules DE, Goldfarb DS, Sevick MA. Nutrient Non-equivalence: Does Restricting High-Potassium Plant Foods Help to Prevent Hyperkalemia in Hemodialysis Patients? J Ren Nutr. 2016 Sep;26(5):282-7. doi: 10.1053/j.jrn.2016.02.005. Epub 2016 Mar 12.
PubMed 26975777Cummings JH, Hill MJ, Jenkins DJ, Pearson JR, Wiggins HS. Changes in fecal composition and colonic function due to cereal fiber. Am J Clin Nutr. 1976 Dec;29(12):1468-73. doi: 10.1093/ajcn/29.12.1468.
PubMed 998555Allon M, Dansby L, Shanklin N. Glucose modulation of the disposal of an acute potassium load in patients with end-stage renal disease. Am J Med. 1993 May;94(5):475-482. doi: 10.1016/0002-9343(93)90081-Y.
PubMed 8498392
Study at a glance
From the registry record, last updated by the sponsor on 27 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT05086185
- Acronym / sponsor ID
- 1596754
- Keywords
- Hyperkalemia, Hemodialysis, Chronic kidney disease, Dietary fiber
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 7 participants (actual)
- Lead sponsor
- University of Nevada, RenoUniversity, hospital or other
- Collaborators
- United States Department of Agriculture (USDA), Sierra Nevada Nephrology Consultants, Inc.
- Study start
- 29 Jun 2021 (actual)
- Primary completion
- 5 Oct 2023 (actual)
- Study completion
- 5 Oct 2023 (actual)
- First posted
- 20 Oct 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.
High blood potassium levels (hyperkalemia) is a major problem for people with kidney failure undergoing hemodialysis treatment. In order to reduce the risk of hyperkalemia, people with kidney failure are advised to limit or avoid high-potassium foods. However, high-potassium foods comprise many healthy food choices, including commonly consumed fruits and vegetables that are key sources of dietary fiber, and other important nutrients.
Risk of hyperkalemia from dietary potassium intake is most notable in the first few hours after a meal when ingested potassium enters the bloodstream. In general, dietary potassium is very well absorbed. However, dietary fiber has been shown to increase the proportion of dietary potassium that is excreted in stool. Based on these findings, it has been proposed that fiber may help to lower the risk of hyperkalemia in people with kidney disease. It remains unclear whether dietary fiber increases potassium excretion in stool by reducing the absorption of dietary potassium, or by drawing body potassium into the bowels by increasing stool bulk. The distinction may be important, as reducing potassium absorption would be expected to be of greater benefit in preventing hyperkalemia caused by eating high-potassium foods.
In this study, the investigators will assess whether a fiber supplement can reduce the effect of dietary potassium from orange juice on blood potassium levels in people with kidney disease undergoing maintenance hemodialysis treatment.
Detailed description
The source population for this study will be adults (18-89 years old) with kidney failure undergoing thrice weekly maintenance hemodialysis (HD) treatment. Participants will include 10 patients without diabetes mellitus, and 10 patients with type 2 diabetes mellitus (T2D) that is being managed with lifestyle with or without long-acting insulin. Patients with a moderate hyperkalemia (>6.5 mEq/L) in the last 6-months, taking potassium-lowering medications, having gastrointestinal (GI) disorders that may alter potassium digestion and absorption, and low hemoglobin concentrations (<10.0 g/dL) will be excluded. In addition, participants who are deemed inappropriate for the intervention by the study Nephrologist based on cognition, prognosis or pending treatments will be excluded.
Once enrolled, participants will be asked to complete questionnaires on demographics, dietary intake, GI symptoms, and urine output. In addition, baseline data on anthropometrics, physical function, medical history and blood parameters will be obtained by physical exam and review of medical records.
Treatment measurement visits will be conducted on the same non-dialysis treatment days at the University of Nevada, Reno Clinical Research Center with participants in a fasted state. Serial blood samples will be collected before, and 60, 120 and 180 minutes after ingesting orange juice providing 0.35 mEq/kg dose of potassium alone, or with 0.15 g/kg of psyllium-based fiber. The sequence of treatments (1) orange juice or 2) orange juice + fiber) will be randomly assigned with equal allocation by T2D status. If a participant's body weight exceeds 120% of ideal body weight (IBW), then the dose of orange juice and fiber will be based on adjusted body weight.
Blood tests at times 0 and 60-minutes post-treatment will be analyzed for the basic metabolic panel plus insulin, and the 120- and 180-minutes blood samples will be analyzed for potassium concentrations. The kalemic response to study treatments will assessed based on: 1) peak change in plasma potassium concentrations, and 2) total area under the curve for plasma potassium until 180-minutes. These parameters will be compared across treatment conditions using paired t-test. If non-normally distributed, values will be log-transformed prior to analyses.
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Orange Juice (control) | – | Diagnostic Test: Kalemic Response to Orange JuiceOrange juice providing a 0.35 mEq/kg dose of potassium |
| Orange Juice plus Fiber | – | Dietary Supplement: Kalemic Response to Orange Juice with FiberSame amount of orange juice as Orange Juice treatment with 0.15 g/kg of psyllium-based fiber added |
Who may qualify
- Ages
- 18 to 89 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- The source population for this intervention will be adults (18-89 years) with kidney failure undergoing thrice-weekly maintenance hemodialysis treatment
Key inclusion criteria (2 listed)
- Kidney failure undergoing thrice-weekly maintenance hemodialysis
- 10 patients without diabetes mellitus, and 10 patients with type 2 diabetes mellitus (T2D) that are being managed with lifestyle and/or long-acting insulin
Key exclusion criteria (6 listed)
- Moderate hyperkalemia (>6.5 mEq/L) in the last 6-months.
- Potassium-lowering medications
- Gastrointestinal (GI) diseases that may alter potassium digestion and absorption.
- Low hemoglobin concentrations (<10.0 g/dL).
- Deemed to be inappropriate for the intervention by Study Nephrologist based on cognition, prognosis, or pending treatments
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 |
|---|---|---|
| Kalemic Response to Orange Juice100% pulp-free orange juice | Diagnostic test | Orange Juice (control) |
| Kalemic Response to Orange Juice with Fiber100% pulp-free orange juice with psyllium-based fiber added | Dietary supplement | Orange Juice plus Fiber |
Primary outcome
Peak change in plasma potassium levels
Time frame: 0 to 180-minutes
The kalemic response to study treatments will be assessed based on peak change in plasma potassium concentrations compared to pre-treatment.
Plasma potassium area under the curve
Time frame: 0 to 180-minutes
The kalemic response to study treatments will be assessed based on total area under the curve for plasma potassium concentrations from pre-treatment to 180-minutes.
2 secondary outcomes
Peak change in plasma potassium levels by diabetes status
Time frame: 0 to 180-minutes
Plasma potassium area under the curve by diabetes status
Time frame: 0 to 180-minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Mar 2025.
- Background: PubMed 26975777St-Jules DE, Goldfarb DS, Sevick MA. Nutrient Non-equivalence: Does Restricting High-Potassium Plant Foods Help to Prevent Hyperkalemia in Hemodialysis Patients? J Ren Nutr. 2016 Sep;26(5):282-7. doi: 10.1053/j.jrn.2016.02.005. Epub 2016 Mar 12.
- Background: PubMed 998555Cummings JH, Hill MJ, Jenkins DJ, Pearson JR, Wiggins HS. Changes in fecal composition and colonic function due to cereal fiber. Am J Clin Nutr. 1976 Dec;29(12):1468-73. doi: 10.1093/ajcn/29.12.1468.
- Background: PubMed 8498392Allon M, Dansby L, Shanklin N. Glucose modulation of the disposal of an acute potassium load in patients with end-stage renal disease. Am J Med. 1993 May;94(5):475-482. doi: 10.1016/0002-9343(93)90081-Y.
- Individual participant dataSharing planned: Yes. The IPD will be available after being unidentified to those who will contact the principal investigator for research purposes.
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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.
David E St-jules, PhD principal investigator
University of Nevada, Reno
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Hyperkalemia and Chronic Kidney Disease Requiring Chronic Dialysis, run by University of Nevada, Reno 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 2 inclusion and 6 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: finished, as of the sponsor's last update on 27 Mar 2025. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Peak change in plasma potassium levels (time frame: 0 to 180-minutes). 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?
On the ClinicalTrials.gov record for NCT05086185, which also lists 3 linked publications.
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 27 Mar 2025.