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| Name | Class |
|---|---|
| Saskatchewan Pulse Growers | OTHER |
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A single blind, six week dietary intervention will be conducted in order to evaluate the impact of fiber fortified foods on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function.
Chronic Kidney Disease (CKD) patients may consume lower than recommended amounts of dietary fiber due to typical dietary habits, dietary restrictions, and uremic symptoms. A progressive decline in kidney function causes an accumulation of uremic molecules that contribute to further progression of the disease and reduced quality of life. In an effort to evaluate the impact of added fiber on blood urea nitrogen, kidney function and quality of life in patients presenting with a moderate to severe decline in kidney function (eGFR ≤ 50 mL/min/1.73 m2), a single blind, six week dietary intervention, clinical trial will be conducted.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Foods | Placebo Comparator | For a period of 2 weeks, participants will consume control foods in addition to their usual diets. |
|
| Fiber Fortified Foods | Experimental | For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Control Food | Other | For a period of 2 weeks, participants will consume control foods in addition to their usual diets. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Impact of added fiber on blood urea nitrogen (BUN) | Blood samples (10 mL) will be taken on day 1, 14, 28, and 42. BUN will be assayed using the Urea Nitrogen Concentrated Reagent method. | up to 42 days of the study |
| Measure | Description | Time Frame |
|---|---|---|
| Impact of foods with added fiber on estimated Glomerular Filtration Rate (eGFR) | eGFR will be calculated using the Modification of Diet in Renal Disease formula on days 1, 14, 28 and 42 of the study. | Days 1, 14, 28 and 42 of the study |
| Impact of foods with added fiber on Serum Creatinine |
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Inclusion Criteria:
Participants must:
Exclusion Criteria:
Participants must not:
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| Name | Affiliation | Role |
|---|---|---|
| Wendy J Dahl, PhD, RD | University of Florida | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Florida | Gainesville | Florida | 32611 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 24304924 | Derived | Salmean YA, Zello GA, Dahl WJ. Foods with added fiber improve stool frequency in individuals with chronic kidney disease with no impact on appetite or overall quality of life. BMC Res Notes. 2013 Dec 5;6:510. doi: 10.1186/1756-0500-6-510. |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| D064088 | Hazard Analysis and Critical Control Points |
| D004043 | Dietary Fiber |
| ID | Term |
|---|---|
| D059022 | Food Safety |
| D063427 | Food Quality |
| D005524 | Food Technology |
| D019649 | Food Industry |
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| Fiber Fortified Food | Other | For a period of 4 weeks, participants will consume food fortified with fiber in addition to their usual diets. |
|
|
Serum creatinine will be assayed using the ADVIA Chemistry CRE_2c method. |
| Days 1, 14, 28 and 42 of the study |
| Impact of foods with added fiber on bowel movement frequency | Participants will complete daily diaries to evaluate bowel movement frequency. | Daily |
| Impact of foods with added fiber on Kidney Disease Quality of Life (KDQOL-36) questionnaire | Participants will complete the Kidney Disease Quality of Life (KDQOL-36) questionnaire for 4 specific days during the study. | Days 1, 14, 28 and 42 |
| Impact of foods with added fiber on Simplified Nutritional Appetite Questionnaire (SNAQ) | Days 1, 14, 28 and 42 of the study |
| Impact of foods with added fiber on Epworth Sleepiness Scale (ESS) | Days 1, 14, 28 and 42 of the study |
| Impact of foods with added fiber on Gastrointestinal Symptom Rating Scale (GSRS) | Days 1, 14, 28 and 42 of the study |
| 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 |
| D007221 |
| Industry |
| D013676 | Technology, Industry, and Agriculture |
| D012449 | Safety |
| D000056 | Accident Prevention |
| D000059 | Accidents |
| D011634 | Public Health |
| D004778 | Environment and Public Health |
| D004040 | Dietary Carbohydrates |
| D002241 | Carbohydrates |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |