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The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.
Phosphorus is a mineral that is found in foods such as dairy products, nuts, and meat, and is important for strengthening the bones. However, too much phosphorus in the blood may be bad for the health of your heart and blood vessels. The kidneys keep the blood levels of phosphorus normal by getting rid of extra phosphorus in the urine. New research has found that common forms of food additives that are high in phosphorus may increase blood phosphorus levels in individuals with kidney disease. In addition, these food additives may increase blood levels of hormones that control phosphorus such as parathyroid hormone (PTH) and fibroblast growth factor 23 (FGF23). Like high blood phosphorus levels, high levels of PTH and FGF23 in the blood may also be bad for the health of your heart and blood vessels. In this study, the investigators would like to examine the effects of food additives on blood levels of phosphorus, PTH and FGF23 in individuals with normal kidney function.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subjects with healthy kidney function | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Research diet | Other | Participants will be provided specially prepared meals to eat at home for two weeks. During the first week, participants will eat foods that do not have any phosphorus-based food additives in them (this is called the control diet). During the second week, participants will eat foods that all have phosphorus-based food additives in them (called the intervention diet). |
| Measure | Description | Time Frame |
|---|---|---|
| FGF23 | Change in FGF23 levels | 2 weeks |
| PTH | Change in PTH levels over 2 weeks | 2 weeks |
| Serum phosphate | Change in serum phosphate over two weeks | 2 weeks |
| Measure | Description | Time Frame |
|---|---|---|
| Insulin sensitivity as measured by HOMA-IR | changes in HOMA-IR over two weeks | 2 weeks |
| Brachial flow mediated dilatation measured by ultrasound | change in flow mediated dilatation over two weeks |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Orlando M Gutierrez, MD, MMSc | University of Alabama at Birmingham | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Alabama | Birmingham | Alabama | 35294 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 32278118 | Derived | Gutierrez OM, Porter AK, Viggeswarapu M, Roberts JL, Beck GR Jr. Effects of phosphorus and calcium to phosphorus consumption ratio on mineral metabolism and cardiometabolic health. J Nutr Biochem. 2020 Jun;80:108374. doi: 10.1016/j.jnutbio.2020.108374. Epub 2020 Mar 19. | |
| 26323022 | Derived | Gutierrez OM, Luzuriaga-McPherson A, Lin Y, Gilbert LC, Ha SW, Beck GR Jr. Impact of Phosphorus-Based Food Additives on Bone and Mineral Metabolism. J Clin Endocrinol Metab. 2015 Nov;100(11):4264-71. doi: 10.1210/jc.2015-2279. Epub 2015 Aug 31. |
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| 2 weeks |