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The purpose of this study is to evaluate the efficacy of plant-protein diets for 12 weeks in patients with advanced chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A dietary intervention of plant-protein based diets | Experimental |
| |
| A dietary intervention of control diets | Active Comparator |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Plant-protein Diets | Other | Participants will consume meals with 70% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk. |
| Measure | Description | Time Frame |
|---|---|---|
| Change in serum levels of indoxyl sulfate, p-Cresyl sulfate and trimethylamine N-Oxide | 4 weeks after starting intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Change in eGFR | 4 weeks after starting intervention | |
| Change in urinary protein creatinine ratio | 4 weeks after starting intervention | |
| Change in serum bicarbonete levels |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Nephrology, Osaka University | Suita | Osaka | 5650871 | Japan |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| D000138 | Acidosis |
| D012080 | Chronic Kidney Disease-Mineral and Bone Disorder |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| Control Diets | Other | Participants will consume meals with 50% plant-based protein three times a day. Participants will be prohibited to have meals other than experimental diets and to drink milk and soy milk. |
|
| 4 weeks after starting intervention |
| Change in urinary citrate to creatinine ratio | The measurement of this outcome was abandoned because of the end of sales for its measuring reagent (F-kit citrate; JK International, Tokyo, Japan) in Japan on December 23, 2022. This decision had been made before we initiatited the recruitement of study participants. | 4 weeks after starting intervention |
| Change in blood pressure | 4 weeks after starting intervention |
| Change in serum levels of calcium, phosphate, intact parathyroid hormone and intact fibroblast growth factor 23 | 4 weeks after starting intervention |
| Change in serum levels of acetic acid, propionic acid and butyric acid | 4 weeks after starting intervention |
| Diversity and composition of the gut microbiota | 4 weeks after starting intervention |
| Change in muscle mass | 4 weeks after starting intervention |
| Dietary adherence | How many times participants have the study diet during the study period. | 4 weeks after starting intervention |
| The number of oral medications including antihypertensive drugs, diuretics, potassium tablets, potassium binders, phosphate binders, calcium tablets, active vitamin D3 analogs and sodium bicarbonate | 4 weeks after starting intervention |
| 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 |
| D000137 | Acid-Base Imbalance |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D012279 | Rickets |
| D001851 | Bone Diseases, Metabolic |
| D001847 | Bone Diseases |
| D009140 | Musculoskeletal Diseases |
| D002128 | Calcium Metabolism Disorders |
| D014808 | Vitamin D Deficiency |
| D001361 | Avitaminosis |
| D003677 | Deficiency Diseases |
| D044342 | Malnutrition |
| D009748 | Nutrition Disorders |
| D006962 | Hyperparathyroidism, Secondary |
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |