Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

Not Applicable

Completed

• Conditions: Phosphate Overload
• Interventions: Other: Meal

• Registration Number: NCT05401552
• Lead Sponsor: Clinical Evaluation Research Unit at Kingston General Hospital

Brief Summary

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

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.

Study Timeline

• Study Start: 2018-05-11
• Primary Completion: 2018-09-01
• Study Completion: 2018-09-01
• Study First Submitted: 2022-04-27
• Status Verified: 2022-05
• Study First Submitted QC: 2022-05-27
• Last Update Submitted: 2022-05-27
• Study First Posted: 2022-06-02
• Last Update Posted: 2022-06-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 18

Inclusion Criteria

Not provided

Exclusion Criteria

• kidney disease

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Convenience breakfast meal	Meal	One cheese tea biscuit and Eggo waffle
Healthy breakfast meal	Meal	One cup of All-Bran breakfast cereal with milk and a piece of fruit

Primary Outcome Measures

Name	Time	Method
Urine phosphate excretion	4 hours	The amount of phosphate excreted into the urine

Secondary Outcome Measures

Name	Time	Method
Parathyroid hormone	4 hours	blood level of parathyroid hormone
Blood phosphate and calcium	3 hours	blood levels of phosphate and calcium
urine calcium excretion	4 hours	The amount of calcium excreted into the urine

Trial Locations

Locations (2)

Rachel Holden; 🇨🇦 Kingston, Ontario, Canada

Queen's University; 🇨🇦 Kingston, Ontario, Canada