Effect of Viscous Fiber on Postprandial Kalemic Response in Hemodialysis Patients

NCT05086185 | Completed

• 1 other identifier: 1596754
• Study Type: observational
• Target: 7
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Hyperkalemia; Chronic Kidney Disease Requiring Chronic Dialysis

Keywords

Hyperkalemia; Hemodialysis; Chronic kidney disease; Dietary fiber

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  0 to 180-minutes

Secondary Outcomes (2)

• Peak change in plasma potassium levels by diabetes status

  0 to 180-minutes

• Plasma potassium area under the curve by diabetes status

  0 to 180-minutes

Study Arms (2)

Orange Juice (control)

Orange juice providing a 0.35 mEq/kg dose of potassium

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

Dietary Supplement: Kalemic Response to Orange Juice with Fiber

Interventions

Kalemic Response to Orange Juice DIAGNOSTIC_TEST

100% pulp-free orange juice

Orange Juice (control)

Kalemic Response to Orange Juice with Fiber DIETARY_SUPPLEMENT

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

Orange Juice plus Fiber

Eligibility Criteria

• Age: 18 Years - 89 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

The source population for this intervention will be adults (18-89 years) with kidney failure undergoing thrice-weekly maintenance hemodialysis treatment

You may qualify if:

• Kidney failure undergoing thrice-weekly maintenance hemodialysis
• patients without diabetes mellitus, and 10 patients with type 2 diabetes mellitus (T2D) that are being managed with lifestyle and/or long-acting insulin

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Nevada, Reno: lead
• United States Department of Agriculture (USDA): collaborator
• Sierra Nevada Nephrology Consultants, Inc.: collaborator

Study Sites (1)

University of Nevada,Reno

Reno, Nevada, 89557, United States

Location

Related Publications (3)

• 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.

  PMID: 26975777 BACKGROUND

• Cummings 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.

  PMID: 998555 BACKGROUND

• Allon 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.

  PMID: 8498392 BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

Blood

MeSH Terms

Conditions

Hyperkalemia; Renal Insufficiency, Chronic

Interventions

Dietary Fiber

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Dietary Carbohydrates; Carbohydrates; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Officials

• David E St-jules, PhD

  University of Nevada, Reno

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 12, 2021
• First Posted: October 20, 2021
• Study Start: June 29, 2021
• Primary Completion: October 5, 2023
• Study Completion: October 5, 2023
• Last Updated: March 27, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: After publishing the primary and secondary outcome paper.
• Access Criteria: Anyone who is interested to do secondary analysis.

Locations

US (1)