Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

NCT ID: NCT05401552

Last Updated: 2022-06-02

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 18 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2018-05-11
• Study Completion Date: 2018-09-01

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.

Conditions

Phosphate Overload

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: OTHER
• Blinding Strategy: NONE

Study Groups

Convenience breakfast meal

One cheese tea biscuit and Eggo waffle

Group Type: ACTIVE_COMPARATOR

Meal

Intervention Type: OTHER

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

Healthy breakfast meal

One cup of All-Bran breakfast cereal with milk and a piece of fruit

Group Type: ACTIVE_COMPARATOR

Meal

Intervention Type: OTHER

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

Interventions

Meal

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

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• healthy

Exclusion Criteria

• kidney disease

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Clinical Evaluation Research Unit at Kingston General Hospital

OTHER

Sponsor Role: lead

Responsible Party

Dr. Rachel Holden

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Rachel M Holden, MD

Role: PRINCIPAL_INVESTIGATOR

Queen's University

Locations

Queen's University

Kingston, Ontario, Canada

Rachel Holden

Kingston, Ontario, Canada

Countries

Canada

Other Identifiers

DMED-2049-17

Identifier Type: -

Identifier Source: org_study_id