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Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

C

Clinical Evaluation Research Unit at Kingston General Hospital

Status

Completed

Conditions

Phosphate Overload

Treatments

Other: Meal

Study type

Interventional

Funder types

Other

Identifiers

NCT05401552
DMED-2049-17

Details and patient eligibility

About

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.

Full 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.

Enrollment

18 patients

Sex

All

Ages

18 to 75 years old

Volunteers

Accepts Healthy Volunteers

Inclusion and exclusion criteria

Inclusion Criteria

  • healthy

Exclusion Criteria:

  • kidney disease

Trial design

Primary purpose

Other

Allocation

Non-Randomized

Interventional model

Crossover Assignment

Masking

None (Open label)

18 participants in 2 patient groups

Convenience breakfast meal
Active Comparator group
Description:
One cheese tea biscuit and Eggo waffle
Treatment:
Other: Meal
Healthy breakfast meal
Active Comparator group
Description:
One cup of All-Bran breakfast cereal with milk and a piece of fruit
Treatment:
Other: Meal

Trial contacts and locations

2

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Data sourced from clinicaltrials.gov

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