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临床试验/NCT07494266
NCT07494266尚未招募不适用

Säkerheten av en hälsosam växtbaserad Kost Med högre kaliuminnerhåll, jämfört Med en hälsosam växtbaserad Kost Med begränsat kaliuminnehåll Hos Patienter Med Kronisk Njursjukdom: En Pilotstudie

Karolinska Institutet1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2026年9月10日最近更新:
适应症
干预措施

试验速览

阶段
不适用
状态
尚未招募
入组人数
30
试验地点
1
主要终点
Number of hyperkalemia (plasma potassium >5.5 mmol/L) events in the two groups

研究概览

简要总结

For many years, people with moderate to advanced chronic kidney disease (CKD) have been advised to limit their intake of potassium, a mineral found in many foods such as fruit, vegetables, legumes, whole grains, and nuts. The reason for this has been the risk of hyperkalemia, a condition in which the potassium level in the blood becomes too high and can be dangerous. In recent years, however, this view has been questioned. New research suggests that the link between potassium in food and high potassium levels in the blood may not be as clear as previously thought. People who follow a strict potassium-restricted diet experience a lower quality of life and less satisfaction with their dietary treatment. At the same time, they miss out on the health benefits of eating a varied and nutritious diet.

Today, many experts advocate a more individualized approach to potassium intake: instead of generally restricting potassium, the goal should be to maintain normal potassium levels in the blood, while encouraging a healthy diet. However, this message is not always clear in healthcare, and many people therefore continue to avoid potassium-rich foods altogether. The result is that they eat fewer natural ingredients and instead consume more processed and ultra-processed foods. Such foods can be more harmful, partly because they often contain potassium additives that are absorbed effectively by the body and their quantities are not reported in the nutritional label. This "hidden" potassium can contribute more to high potassium levels in the blood than the potassium that occurs naturally in plant-based foods. In addition, potassium from whole plant-based foods is absorbed more slowly, partly due to its fiber content.

Plant-based diets may also have other positive effects for people with kidney disease: they can contribute to reduced blood acidity, known as metabolic acidosis, healthier gut flora, lower levels of inflammation, and reduced phosphorus intake. Together, these factors can counteract several of the metabolic complications associated with kidney disease.

In a previous study, our research group showed that even patients with advanced kidney disease (CKD stage 4-5) and already elevated potassium levels could follow a healthy plant-based diet if they also used a potassium-binding drug (sodium zirconium cyclosilicate, SZC). This enabled them to eat more fruit, vegetables, and legumes, while also experiencing improved quality of life. The current study builds on these results and is planned as a pilot study in which patients with moderate to advanced kidney disease, but who are not yet being treated with dialysis, are assigned to two different dietary strategies for six months:

  • Healthy plant-based diet (healthy-PBD): a more liberal and balanced plant-based diet without specific potassium restrictions.
  • Potassium-restricted plant-based diet (restricted-PBD): a traditional plant-based diet with restrictions on potassium-rich foods, according to current standard recommendations.

The main purpose is to investigate whether the healthy plant-based diet leads to more or more severe cases of hyperkalemia than the restricted diet. Our hypothesis is that potassium levels may increase slightly in the group with a liberal diet, but not to dangerous levels. The study will also examine secondary outcomes, such as quality of life, satisfaction with treatment, and how well patients accept the diet. In addition, taste experiences will be tested with taste strips (sweet, sour, salt, bitter and umami) before and after the intervention in both groups. If this pilot study shows that a healthier and less restrictive diet is safe, it could pave the way for a larger study investigating the long-term metabolic effects of a plant-based diet in kidney care.

详细描述

The overall aim of the project is to investigate whether a liberal plant-based diet, rich in fruit, vegetables, legumes, whole grains, and nuts, can be recommended to patients with mild to advanced kidney disease without leading to hyperkalemia. Traditionally, dietary advice for chronic kidney disease (CKD) has focused on potassium restriction, which has led to reduced intake of healthy foods and thereby poorer diet quality. This project aims to challenge this view by shifting the focus from potassium content itself to overall diet quality, with a particular focus on patient-centered outcomes such as safety, quality of life, treatment satisfaction, acceptance and sensory effects (taste sensitivity).

The study addresses an important knowledge gap in current nutritional guidelines for patients with kidney disease. The latest recommendations emphasize individualization and maintaining normal potassium levels, rather than general restrictions, but this advice is based on limited evidence and has not yet been tested in longer clinical studies.

This project is therefore limited to conducting a 6-month pilot study with a randomized controlled design. The focus is primarily on safety outcomes, especially the occurrence of hyperkalemia, and secondarily on patient-reported outcomes, dietary acceptance, and taste experience. Metabolic effects are not examined in detail in this study, but the results will form the basis for a larger follow-up study with a broader focus on long-term metabolic and clinical benefits.

The project's main scientific question is whether it is safe for patients with moderate to advanced kidney disease to eat a plant-based diet without restricting potassium-rich foods. In current clinical practice, patients are advised to avoid fruits, vegetables, legumes, and nuts, despite the fact that an increasing number of studies suggest that potassium from whole plant-based foods does not necessarily lead to dangerously high potassium levels in the blood. The study defines the following outcome measures:

Primary outcome: Time to first hyperkalemia event (plasma potassium > 5.5 mmol/L). Number of hyperkalemia events in the two groups during the 22-26 weeks following randomization. Potassium as a continuous variable.

研究设计

研究类型
Interventional
分配方式
Randomized
干预模型
Parallel
主要目的
Treatment
盲法
None

入排标准

年龄范围
20 Years 至 85 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age between 20 and 85 years
  • Chronic kidney disease (CKD) with an estimated glomerular filtration rate (eGFR) <30 mL/min/1.73 m²
  • Normal potassium levels (plasma potassium 3.5-5.3 mmol/L)
  • Not on dialysis
  • Good knowledge of Swedish

排除标准

  • Pregnancy
  • Breastfeeding
  • Kidney transplant
  • Regular use of potassium binders at least 4 days/week (e.g. sodium zirconium cyclosilicate, patiromer or sodium polystyrene sulfonate)
  • Regular prescription of daily potassium salts (e.g. potassium chloride)
  • Planned kidney transplant
  • Planned start of dialysis within the next 6 months
  • Allergy to nuts (including peanuts)
  • Mental illness and cognitive impairment that impede understanding of dietary advice
  • Comorbidities that may affect potassium balance (e.g. adrenal insufficiency, inflammatory bowel disease, chronic diarrhoea or colostomy)

研究组 & 干预措施

Healthy plant-based diet (healthy-PBD)

Experimental

干预措施: Healthy plant-based diet (healthy-PBD) (Other)

Potassium-restricted plant-based diet (restricted-PBD)

Active Comparator

干预措施: Potassium-restricted plant-based diet (Other)

结局指标

主要结局

Number of hyperkalemia (plasma potassium >5.5 mmol/L) events in the two groups

时间窗: for 26 weeks following randomization

Hyperkalemia is defined as plasma potassium \> 5.5 mmol/L. The number of hyperkalemia events, as well as the time to the event, will be registered.

次要结局

  • Quality of life (RAND-36 questionnaire - score 0 to 100)(for 26 weeks following randomization)
  • Renal Treatment Satisfaction Questionnaire - score 0 to 6(for 26 weeks following randomization)
  • C-reactive protein (mg/L)(for 26 weeks following randomization)
  • Interleukin 6 (pg/mL)(for 26 weeks following randomization)
  • Glomerular filtration rate (ml/min/1.73 m2)(for 26 weeks following randomization)
  • Albumin/creatinine ratio (spot urine) (mg/g)(for 26 weeks following randomization)
  • 24-hour urinary creatinine excretion (mg/L)(for 26 weeks following randomization)
  • Serum creatinine (µmol/L)(for 26 weeks following randomization)
  • Plasma carbon dioxide (mmol/L)(for 26 weeks following randomization)
  • Plasma Trimethylamine N-oxide (TMAO) (ng/mL)(for 26 weeks following randomization)
  • Plasma p-Cresyl sulfate (ng/mL)(for 26 weeks following randomization)
  • Plasma Indoxyl sulfate (ng/mL)(for 26 weeks following randomization)
  • Vitamin K(for 26 weeks following randomization)
  • Blood DNA microbial(for 26 weeks following randomization)
  • Lean body mass (kg)(for 26 weeks following randomization)
  • Body weight (kg)(for 26 weeks following randomization)
  • Potassium intake (mg/day)(for 26 weeks following randomization)
  • Taste perception of salt (scale 1 to 4)(for 26 weeks following randomization)
  • Dietary compliance(for 26 weeks following randomization)
  • 24-hour potassium excretion in urine (mmol/day)(for 26 weeks following randomization)
  • Plasma potassium as a continuous variable(26 weeks following the randomization)
  • Height (cm)(26 weeks after the randomization)
  • Taste perception of sweet (scale 1 to 4)(26 weeks after the randomization)
  • Taste perception to sour (scale 1 to 4)(26 weeks followed the randomization)
  • Taste perception of bitter (scale 1 to 4)(26 weeks followed the randomization)

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Carla Maria Avesani

RD, PhD, Associate Professor in Nutrition, Senior Research Specialist

Karolinska Institutet

研究点 (1)

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