Impact of Food Additives on Phosphorus Metabolism

Not Applicable

Completed

• Conditions: Healthy
• Interventions: Other: Research diet

• Registration Number: NCT01394146
• Lead Sponsor: University of Alabama at Birmingham

Brief Summary

The purpose of the study is to learn more about how phosphorus-based food additives affect phosphorus metabolism in people with normal kidney function.

Detailed Description

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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2011-04
• Study First Submitted: 2011-07-12
• Study First Submitted QC: 2011-07-13
• Study First Posted: 2011-07-14
• Primary Completion: 2014-06
• Study Completion: 2014-06
• Status Verified: 2015-09
• Last Update Submitted: 2015-09-28
• Last Update Posted: 2015-09-30

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 54

Inclusion Criteria

• Healthy volunteers, 19 - 45 years of age

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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).

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Subjects with healthy kidney function	Research diet	-

Primary Outcome Measures

Name	Time	Method
FGF23	2 weeks	Change in FGF23 levels
PTH	2 weeks	Change in PTH levels over 2 weeks
Serum phosphate	2 weeks	Change in serum phosphate over two weeks

Secondary Outcome Measures

Name	Time	Method
Insulin sensitivity as measured by HOMA-IR	2 weeks	changes in HOMA-IR over two weeks
Brachial flow mediated dilatation measured by ultrasound	2 weeks	change in flow mediated dilatation over two weeks

Trial Locations

Locations (1)

University of Alabama; 🇺🇸 Birmingham, Alabama, United States