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Completed

NCT Number: NCT05401552

Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

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.

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Key information

Conditions

Phosphate Overload

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Queen's University, Kingston, Ontario, Canada

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • healthy

Exclusion criteria

  • kidney disease

Treatment and study plan

Meal

Other

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

Primary outcomes

  1. Urine phosphate excretion

    Time frame: 4 hours

    The amount of phosphate excreted into the urine

Secondary outcomes

  1. urine calcium excretion

    Time frame: 4 hours

    The amount of calcium excreted into the urine

  2. Blood phosphate and calcium

    Time frame: 3 hours

    blood levels of phosphate and calcium

  3. Parathyroid hormone

    Time frame: 4 hours

    blood level of parathyroid hormone

Sponsors and collaborators

Lead sponsor

Clinical Evaluation Research Unit at Kingston General Hospital

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Jun 2, 2022
Registry last updated
Jun 2, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

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This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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