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NCT Number: NCT05086185

Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients

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.

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Key information

Conditions

Hyperkalemia Chronic Disease Chronic Kidney Disease Requiring Chronic Dialysis Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Water-Electrolyte Imbalance

Age range

18 year–89 year

Sex eligibility

All sexes

Study type

Observational

Primary location

University of Nevada,Reno

Reno, Nevada, 89557, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

Kalemic Response to Orange Juice

Diagnostic Test

100% pulp-free orange juice

Kalemic Response to Orange Juice with Fiber

Dietary Supplement

100% pulp-free orange juice with psyllium-based fiber added

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Peak change in plasma potassium levels by diabetes status

    Time frame: 0 to 180-minutes

    The kalemic response to study treatments (Primary Outcome 1) will be compared between participants with and without type 2 diabetes mellitus.

  2. Plasma potassium area under the curve by diabetes status

    Time frame: 0 to 180-minutes

    The kalemic response to study treatments (Primary Outcome 2) will be compared between participants with and without type 2 diabetes mellitus.

Sponsors and collaborators

Lead sponsor

University of Nevada, Reno

Other

Collaborators

  • Sierra Nevada Nephrology Consultants, Inc.
  • United States Department of Agriculture (USDA)

Registry information

Important dates

Study start
2021
Primary completion
2023
Study completion
2023
First posted
Oct 20, 2021
Registry last updated
Mar 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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