Impact of Food Additives on Phosphorus Metabolism
The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
|Official Title:||Impact of Food Additives on Phosphorus Metabolism|
- FGF23 [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Change in FGF23 levels
- PTH [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Change in PTH levels over 2 weeks
- Serum phosphate [ Time Frame: 2 weeks ] [ Designated as safety issue: No ]Change in serum phosphate over two weeks
|Study Start Date:||April 2011|
|Study Completion Date:||June 2014|
|Primary Completion Date:||June 2014 (Final data collection date for primary outcome measure)|
|Experimental: Subjects with healthy kidney function||
Other: Research diet
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).
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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01394146
|United States, Alabama|
|University of Alabama|
|Birmingham, Alabama, United States, 35294|
|Principal Investigator:||Orlando M Gutierrez, MD, MMSc||University of Alabama at Birmingham|