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| ID | Type | Description | Link |
|---|---|---|---|
| K12TR004415 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Center for Advancing Translational Sciences (NCATS) | NIH |
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The goal of this crossover clinical trial is to explore the effects of red meat intake on serum and fractional urinary excretion of uremic toxins including trimethylamine N-oxide in people with chronic kidney disease.
This study will be a single-blind crossover, human-feeding study comparing 3 weeks of a lacto-ovo vegetarian diet to the same diet with 20% of the protein replaced by red meat. There will be a 2-week baseline period and a 5-week washout period where participants will consume their typical, self-selected diet. Once eligible, the participant will be randomized to a diet order. The investigators will recruit up to 15 participants. Descriptive statistics (means and standard deviations) will be used to summarize the characteristics of the study population. In general, data will be analyzed using linear mixed-effect models to account for the potential correlation among measurements from the same participant. A power analysis of this pilot study will be conducted based on the estimated interparticipant and intraparticipant variabilities to estimate the required number of participants to detect a certain size of difference with a certain power for a full study.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Lacto-ovo vegetarian diet alone; then lacto-ovo vegetarian with red meat diet | Experimental | Participants will be assigned to a lacto-ovo vegetarian diet providing 0.8 g/kg/day of protein for the first treatment period; they will then be assigned to continue this diet with 20% of the protein replaced by red meet for the second treatment period. |
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| Lacto-ovo vegetarian with red meat diet; then lacto-ovo vegetarian diet alone | Experimental | Participants will be assigned to a lacto-ovo vegetarian diet with 20% of the protein replaced by red meat for the first treatment period; they will then be assigned to a lacto-ovo vegetarian diet alone for the second treatment period. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Controlled dietary intervention | Other | Participants will complete a 2-week baseline period consuming their standard diet without any food or beverages provided followed by a randomized, crossover-controlled feeding study of a lacto-ovo vegetarian diet versus the same diet with 20% of the protein replaced by red meat. In between the two diets, there will be a five-week washout where participants will consume their standard diet without any food or beverages provided. |
| Measure | Description | Time Frame |
|---|---|---|
| Serum trimethylamine N-oxide | Intra- and interparticipant variability of serum concentrations as measured by high performance liquid chromatography-mass spectrometry | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Measure | Description | Time Frame |
|---|---|---|
| Additional serum uremic toxins | Including p-cresyl sulfate and indoxyl sulfate measured by high performance liquid chromatography-mass spectrometry | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Brandon Kistler | Contact | 765-494-5406 | bmkistle@purdue.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Purdue University | Recruiting | West Lafayette | Indiana | 47906 | United States |
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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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|
| Urinary excretion of uremic toxins |
Measured by a ratio of serum and urine values |
| 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Gut microbiota | Diversity and composition of the gut microbiome | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Gastrointestinal symptoms | Measured at the end of each study period by the Gastrointestinal Symptom Rating Scale. This is a 15-item questionnaire that includes five domains. Each item is scored from 1 to 7 and the mean score in each domain is presented. | 13 Weeks (collections in week 2, 5, 10, and 13 which corresponds to before and during the last week of each of the three-week controlled diet periods). |
| Stool consistency | Measured on a scale from 1 to 7 using the Bristol Stool Scale/Chart. | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Blood pressure | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Arterial Stiffness | Carotid-femoral pulse wave velocity | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Height | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Weight | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Handgrip Strength | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Total cholesterol | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| High density lipoprotein | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Low Density Lipoprotein | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Triglycerides | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Apolipoprotein B | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Blood glucose | Fasting blood glucose | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Serum calcium | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Serum Potassium | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Serum bicarbonate | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Subjective global assessment | Scored on a scale from 1-7 (severely malnourished to well nourished) | 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and during the last week of each of the three-week controlled diet periods). |
| Albumin to creatinine ratio | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Blood urea nitrogen | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Creatinine | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Serum Phosphate | 13 Weeks (collections in week 1, 2, 4, 5, 9, 10, 12, 13 which corresponds to before and during the last two weeks of each of the three-week controlled diet periods). |
| Urinary phosphorus excretion | From 24-hour urine collection | 13 Weeks (collections in week 2, 5, 10, 13 which corresponds to before and after each of the three-week controlled diet periods). |
| 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 |