Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans

May 27, 2022 updated by: Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital

The Impact of Phosphate Bioavailability on the 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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

18

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Kingston, Ontario, Canada, K7L3V6
        • Queen's University
      • Kingston, Ontario, Canada, K7L4B7
        • Rachel Holden

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria

  • healthy

Exclusion Criteria:

  • kidney disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Other
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Convenience breakfast meal
One cheese tea biscuit and Eggo waffle
Other: Meal
Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives
Active Comparator: Healthy breakfast meal
One cup of All-Bran breakfast cereal with milk and a piece of fruit
Other: Meal
Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Urine phosphate excretion
Time Frame: 4 hours
The amount of phosphate excreted into the urine
4 hours

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
urine calcium excretion
Time Frame: 4 hours
The amount of calcium excreted into the urine
4 hours
Blood phosphate and calcium
Time Frame: 3 hours
blood levels of phosphate and calcium
3 hours
Parathyroid hormone
Time Frame: 4 hours
blood level of parathyroid hormone
4 hours

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Clinical Evaluation Research Unit at Kingston General Hospital

Investigators

  • Principal Investigator: Rachel M Holden, MD, Queen's University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 11, 2018

Primary Completion (Actual)

September 1, 2018

Study Completion (Actual)

September 1, 2018

Study Registration Dates

First Submitted

April 27, 2022

First Submitted That Met QC Criteria

May 27, 2022

First Posted (Actual)

June 2, 2022

Study Record Updates

Last Update Posted (Actual)

June 2, 2022

Last Update Submitted That Met QC Criteria

May 27, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Other Study ID Numbers

  • DMED-2049-17

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Undecided

IPD Plan Description

undecided

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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