Low-potassium Content Vegetables in Chronic Kidney Disease
- Conditions
- the Recommended Target of Daily Vegetables IntakeRisk of Hyperkalemia
- Interventions
- Other: low-potassium vegetables
- Registration Number
- NCT06428942
- Brief Summary
Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. Thus, the investigators aim to evaluate whether proving low-potassium content vegetables to this population are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
- Detailed Description
Prior observational studies have shown that higher levels of vegetables and fruits consumption are associated with lower risk of all-cause mortality in patients with chronic kidney disease (CKD). However, compared with the normal population, patients with CKD are more likely to consume less vegetables and fruits. According to the suggestions from 2018 Ministry of Health and Welfare in Taiwan, vegetables intake are at least 3 to 5 servings daily based on the daily energy requirement. In our own data, the average daily vegetables intake was only 2.1 servings among patients with CKD stages 3 to 5 not yet on dialysis. Therefore, the investigators aim to evaluate whether proving low-potassium content vegetables to patients with CKD stages 3 to 5 not yet on dialysis are able to reach the recommended target of daily vegetables intake and not increase the risk of hyperkalemia.
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- All
- Target Recruitment
- 75
- CKD stage 3b~5, not yet on dialysis
- Age ≥20 years
- Stable doses of medications for 4 weeks
- Serum potassium level: ≥3.5 and < 5.5 mmol/L
- Anticipated to receive dialysis within 3 month
- Major gastrointestinal diseases (inflammatory bowel disease, celiac disease) or intestinal resection
- Patients with infection, malignancy, heart failure, liver cirrhosis or impaired cognitive or mental disorders
- Patients who are just hospitalized due to an acute cardiovascular events or infection 3 months prior to the start of study
- Patients with kidney transplants
- Patients who receive immunosuppressant
- Pregnant women or patients who are planning to become pregnant
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Intervention group low-potassium vegetables The participants in the intervention group would receive their daily low-potassium vegetables 3 to 5 serving according to their daily suggested requirement and routine CKD dietary education for 8 weeks.
- Primary Outcome Measures
Name Time Method Percentage of participants who reach the targets of daily vegetable recommended target 8 weeks Percentage of participants who reach the targets of daily vegetable recommended
- Secondary Outcome Measures
Name Time Method Proteinuria 8 weeks Change in proteinuria in g/day
Occurrence of moderate hyperkalemia 8 weeks serum \[potassium\] \>=5.5 mmol/L
Gut microbiome 8 weeks Change in alpha- and beta-diversities indices
Gut-derived uremic toxins 8 weeks Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate)
Serum creatinine 8 weeks Change in serum creatinine in mg/dL
Status of constipation 8 weeks Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome.
Trial Locations
- Locations (1)
Taipei Tzu Chi Hospital
🇨🇳New Taipei City, Taiwan