Impact of Food Additives on Phosphorus Metabolism
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 54
- 试验地点
- 2
- 主要终点
- FGF23
研究概览
简要总结
The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 19 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Healthy volunteers, 19 - 45 years of age
排除标准
- •abnormal urinalysis-presence of hematuria, proteinuria, or leukocyturia.
- •pregnancy or breast-feeding
- •Medical conditions impacting phosphate metabolism-primary hyperparathyroidism; gastrointestinal malabsorption disorders such as Crohn's Disease, ulcerative colitis, celiac disease, or liver dysfunction; hyper- or hypothyroidism; irregular menses for female subjects.
- •Body Mass Index (BMI) ≥ 30 g/m2 since obesity is independently associated with impaired phosphorus metabolism.
- •Medications known to affect phosphorus metabolism- current use of phosphorus supplements, high-dose or activated vitamin D compounds, regular antacid or laxative use, anticonvulsants.
- •Hyper- or hypophosphatemia (≥ 4.6 mg/dl or ≤ 2.5 mg/dl respectively), hyper- or hypocalcemia (≥ 10.6 or ≤ 8.5 mg/dl respectively), or severe anemia (hemoglobin < 8 g/dl for women and < 9 g/dl for men).
结局指标
主要结局
FGF23
时间窗: 2 weeks
Change in FGF23 levels
PTH
时间窗: 2 weeks
Change in PTH levels over 2 weeks
Serum phosphate
时间窗: 2 weeks
Change in serum phosphate over two weeks
次要结局
- Insulin sensitivity as measured by HOMA-IR(2 weeks)
- Brachial flow mediated dilatation measured by ultrasound(2 weeks)
研究者
Orlando M. Gutierrez, MD, MMSc
Assistant Professor
University of Alabama at Birmingham