Phosphate OverloadNCT05401552
Phosphate Bioavailability Hormonal Response to a Breakfast Meal in Healthy Humans
A study testing Meal in people with Phosphate Overload, run by Clinical Evaluation Research Unit at Kingston General Hospital at 2 sites in Canada.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 yearsHealthy volunteers can take part
- Conditions the study is for
- Phosphate Overload
- What is being tested?
- Meal
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 2 sitesCanada
- Study dates
- 11 May 2018to 1 Sep 2018
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- healthy
Who cannot join
- kidney disease
Trial locations and contacts
2 sites in 1 country.
Canada2 sites
Queen's University
Kingston, Ontario, K7L3V6
Rachel Holden
Kingston, Ontario, K7L4B7
About this study
Official title: 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.
Read the 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
- Being tested
- Meal
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MealOther
Comparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives
| Study group | Role | What they receive |
|---|---|---|
| Convenience breakfast meal | Active comparator | One cheese tea biscuit and Eggo waffle Receives: Other: Meal |
| Healthy breakfast meal | Active comparator | One cup of All-Bran breakfast cereal with milk and a piece of fruit Receives: Other: Meal |
What is being measured
The primary outcome is the main question the study is designed to answer.
Urine phosphate excretion
The amount of phosphate excreted into the urine
Measured: 4 hours
Secondary outcomes (3)
urine calcium excretion
The amount of calcium excreted into the urine
Measured: 4 hours
Blood phosphate and calcium
blood levels of phosphate and calcium
Measured: 3 hours
Parathyroid hormone
blood level of parathyroid hormone
Measured: 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2022
- Study start11 May 2018
- Primary completion1 Sep 2018
- Study completion1 Sep 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Phosphate OverloadStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Model description
- cross-over design
- Masking
- None (open label)
- Enrolment
- 18 participants (actual)
Sponsor and investigators
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Rachel Holden, Clinical Evaluation Research Unit at Kingston General Hospital
- Investigators
- Rachel M Holden, MD, Principal investigator, Queen's University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05401552
- Sponsor's protocol ID
- DMED-2049-17
- Status last verified
- May 2022
- First submitted
- 27 Apr 2022
- Last updated
- 2 Jun 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided: undecided
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Impact of Phosphate Bioavailability on the Hormonal Response to a Breakfast Meal in Healthy Humans
- ClinicalTrials.gov ID
- NCT05401552
- Acronym / sponsor ID
- DMED-2049-17
- Conditions
- Phosphate Overload
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (actual)
- Lead sponsor
- Clinical Evaluation Research Unit at Kingston General HospitalUniversity, hospital or other
- Study start
- 11 May 2018 (actual)
- Primary completion
- 1 Sep 2018 (actual)
- Study completion
- 1 Sep 2018 (actual)
- First posted
- 2 Jun 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Other
- Allocation
- Non-randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- cross-over design
| Arm | Type | Receives |
|---|---|---|
| Convenience breakfast meal | Active comparator | Other: MealOne cheese tea biscuit and Eggo waffle |
| Healthy breakfast meal | Active comparator | Other: MealOne cup of All-Bran breakfast cereal with milk and a piece of fruit |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- healthy
Key exclusion criteria (1 listed)
- kidney disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MealComparison of two breakfast meals containing the same amount of phosphorus but one in the form of inorganic additives | Other | Convenience breakfast meal, Healthy breakfast meal |
Primary outcome
Urine phosphate excretion
Time frame: 4 hours
The amount of phosphate excreted into the urine
3 secondary outcomes
urine calcium excretion
Time frame: 4 hours
Blood phosphate and calcium
Time frame: 3 hours
Parathyroid hormone
Time frame: 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Jun 2022.
- Individual participant dataSharing planned: Undecided. undecided
Related trials for Phosphate Overload
Recruiting
Impact of Dietary Phosphate Excess on Exercise Capacity and Visceral Adiposity
Physical Inactivity, Phosphate Overload
Recruiting
Phosphate Assessment in Chronic Kidney Disease Patients Study
Chronic Kidney Disease (Stage 3-4), Chronic Kidney Disease Mineral and Bone Disorder
Not yet recruitingObservational study
Institution of an Italian Multicenter Database of Patients Affected by Diseases of Phosphate Metabolism
Phosphate Deficiency, Phosphate Overload
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel M Holden, MD principal investigator
Queen's University
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Meal in people with Phosphate Overload, run by Clinical Evaluation Research Unit at Kingston General Hospital at 2 sites in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 2 Jun 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Urine phosphate excretion (time frame: 4 hours). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Jun 2022.