Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

Study Overview
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Brief Summary
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Convenience food is enhanced with phosphate additives in order to modify taste and texture and for preservation. The purpose of this study is to measure the response of phosphate-related hormones to two different types of breakfast meals that contain the same amount of phosphate but in different forms. This study is a cross-over design.

Detailed Description
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In the first meal, the participant will consume a standard convenience breakfast meal comprised of a cheese tea biscuit and two Eggo waffles. The amount of phosphorus contained in this meal is 700 mg and the majority of this phosphate would be in the form of phosphate additives. Urine and blood will be collected before and after consumption of the meal to measure how the body responds to the meal. Specifically, levels of phosphate, calcium, creatinine (measure of kidney function) and three hormones involved in phosphate regulation (parathyroid hormone, fibroblast growth factor-23 and vitamin D) will be measured in each blood sample. Creatinine, calcium and phosphate will be measured in each urine sample. The second meal will also contain 700 mg of phosphorus and similar caloric content but in a healthy breakfast meal that does not contain any phosphate additives, consisting of one cup of All-Bran breakfast cereal with milk and a piece of fruit. The same blood and urine tests will be assessed after the second meal.

Official Title
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The Impact of Phosphate Bioavailability on the Hormonal Response to a Breakfast Meal in Healthy Humans

Conditions
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Phosphate Overload

Intervention / Treatment
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* Other: Meal


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria healthy Exclusion Criteria: kidney disease

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Other
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Interventional Model Description: cross-over design
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Convenience breakfast meal<br>One cheese tea biscuit and Eggo waffle | Other: Meal<br>* Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives<br>|
| Active Comparator: Healthy breakfast meal<br>One cup of All-Bran breakfast cereal with milk and a piece of fruit | Other: Meal<br>* Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urine phosphate excretion | The amount of phosphate excreted into the urine | 4 hours | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| urine calcium excretion | The amount of calcium excreted into the urine | 4 hours | 
| Blood phosphate and calcium | blood levels of phosphate and calcium | 3 hours | 
| Parathyroid hormone | blood level of parathyroid hormone | 4 hours |