NCT05401552

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started May 2018

Shorter than P25 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

May 11, 2018

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2018

Completed
3.7 years until next milestone

First Submitted

Initial submission to the registry

April 27, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

June 2, 2022

Completed
Last Updated

June 2, 2022

Status Verified

May 1, 2022

Enrollment Period

4 months

First QC Date

April 27, 2022

Last Update Submit

May 27, 2022

Conditions

Phosphate Overload

Outcome Measures

Primary Outcomes (1)

  • Urine phosphate excretion

    The amount of phosphate excreted into the urine

    4 hours

Secondary Outcomes (3)

  • urine calcium excretion

    4 hours

  • Blood phosphate and calcium

    3 hours

  • Parathyroid hormone

    4 hours

Study Arms (2)

Convenience breakfast meal

ACTIVE COMPARATOR

One cheese tea biscuit and Eggo waffle

Other: Meal

Healthy breakfast meal

ACTIVE COMPARATOR

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

Other: Meal

Interventions

MealOTHER

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

Convenience breakfast mealHealthy breakfast meal

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • healthy

You may not qualify if:

  • kidney disease

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Queen's University

Kingston, Ontario, K7L3V6, Canada

Location

Rachel Holden

Kingston, Ontario, K7L4B7, Canada

Location

MeSH Terms

Interventions

Meals

Intervention Hierarchy (Ancestors)

FoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Rachel M Holden, MD

    Queen's University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
OTHER
Intervention Model
CROSSOVER
Model Details: cross-over design
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

April 27, 2022

First Posted

June 2, 2022

Study Start

May 11, 2018

Primary Completion

September 1, 2018

Study Completion

September 1, 2018

Last Updated

June 2, 2022

Record last verified: 2022-05

Locations

CA(2)