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Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

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

Status
Completed
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05401552
Enrollment
18
Registered
2022-06-02
Start date
2018-05-11
Completion date
2018-09-01
Last updated
2022-06-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Phosphate Overload

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.

Interventions

OTHERMeal

Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives

Sponsors

Clinical Evaluation Research Unit at Kingston General Hospital
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
NONE

Intervention model description

cross-over design

Eligibility

Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes

Inclusion criteria

* healthy

Exclusion criteria

* kidney disease

Design outcomes

Primary

MeasureTime frameDescription
Urine phosphate excretion4 hoursThe amount of phosphate excreted into the urine

Secondary

MeasureTime frameDescription
urine calcium excretion4 hoursThe amount of calcium excreted into the urine
Blood phosphate and calcium3 hoursblood levels of phosphate and calcium
Parathyroid hormone4 hoursblood level of parathyroid hormone

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026