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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intervention group | Experimental | 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. |
|
| Control group | No Intervention | The participants in the control group would receive routine CKD dietary education for 8 weeks. |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| low-potassium vegetables | Other | low-potassium vegetables 3 to 5 serving according to their daily suggested requirement |
|
| Measure | Description | Time Frame |
|---|---|---|
| Percentage of participants who reach the targets of daily vegetable recommended target | Percentage of participants who reach the targets of daily vegetable recommended | 8 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Gut-derived uremic toxins | Change in gut-derived uremic toxins ( indoxyl sulfate, p-cresyl sulfate) | 8 weeks |
| Serum creatinine | Change in serum creatinine in mg/dL |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| TIng-Yun Lin, MD | Contact | 886-266289779 | 2350 | water_h2o_6@hotmail.com |
| Szu-Chun Hung, MD | Contact | 886-266289779 | 2350 | szuchun.hung@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Szu-Chun Hung, MD | Taichung Tzu Chi Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Taipei Tzu Chi Hospital | Recruiting | New Taipei City | 231 | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 36791982 | Background | Wakasugi M, Yokoseki A, Wada M, Momotsu T, Sato K, Kawashima H, Nakamura K, Onodera O, Narita I. Vegetable and Fruit Intake Frequency and Mortality in Patients With and Without Chronic Kidney Disease: A Hospital-Based Cohort Study. J Ren Nutr. 2023 Jul;33(4):566-574. doi: 10.1053/j.jrn.2023.01.011. Epub 2023 Feb 13. | |
| 31738182 |
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We do not have IPD sharing plan.
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D006947 | Hyperkalemia |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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Participants are randomized to intervention group or control group with ratio of 50:25.
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Masking is not allowed in this study
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| 8 weeks |
| Proteinuria | Change in proteinuria in g/day | 8 weeks |
| Occurrence of moderate hyperkalemia | serum [potassium] >=5.5 mmol/L | 8 weeks |
| Status of constipation | Using the Chinese constipation questionnaire. The minimum value is 0, and the maximum value is 21, and the higher score represents a worse outcome. | 8 weeks |
| Gut microbiome | Change in alpha- and beta-diversities indices | 8 weeks |
| Taipei Tzu Chi Hospital | Recruiting | New Taipei City | Taiwan |
|
| Saglimbene VM, Wong G, Ruospo M, Palmer SC, Garcia-Larsen V, Natale P, Teixeira-Pinto A, Campbell KL, Carrero JJ, Stenvinkel P, Gargano L, Murgo AM, Johnson DW, Tonelli M, Gelfman R, Celia E, Ecder T, Bernat AG, Del Castillo D, Timofte D, Torok M, Bednarek-Skublewska A, Dulawa J, Stroumza P, Hoischen S, Hansis M, Fabricius E, Felaco P, Wollheim C, Hegbrant J, Craig JC, Strippoli GFM. Fruit and Vegetable Intake and Mortality in Adults undergoing Maintenance Hemodialysis. Clin J Am Soc Nephrol. 2019 Feb 7;14(2):250-260. doi: 10.2215/CJN.08580718. Epub 2019 Jan 31. |
| 35798188 | Background | Pourafshar S, Sharma B, Kranz S, Mallawaarachchi I, Kurland E, Ma JZ, Scialla JJ. Patterns of Fruit and Vegetable Intake in Adults With and Without Chronic Kidney Disease in the United States. J Ren Nutr. 2023 Jan;33(1):88-96. doi: 10.1053/j.jrn.2022.06.007. Epub 2022 Jul 5. |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D014883 | Water-Electrolyte Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |