Impact of Food Additives on Phosphorus Metabolism

University of Alabama at Birmingham54 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

Masking

NONE

Enrollment

Conditions

Healthy

Interventions

Research dietOTHER

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).

Eligibility

Sex: ALLMin age: 19 YearsMax age: 45 YearsHealthy volunteers:

Medical Language ↔ Plain English

Inclusion Criteria: * Healthy volunteers, 19 - 45 years of age Exclusion Criteria: * 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).

Locations (1)

University of Alabama

Birmingham, Alabama, United States

Outcomes

Primary Outcomes

FGF23

Change in FGF23 levels

Time frame: 2 weeks

PTH

Change in PTH levels over 2 weeks

Time frame: 2 weeks

Serum phosphate

Change in serum phosphate over two weeks

Time frame: 2 weeks

Secondary Outcomes

Insulin sensitivity as measured by HOMA-IR

changes in HOMA-IR over two weeks

Time frame: 2 weeks

Brachial flow mediated dilatation measured by ultrasound

change in flow mediated dilatation over two weeks

Time frame: 2 weeks

Data from ClinicalTrials.gov

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