Cardiovascular Risk FactorNCT03771924
Postprandial Response of Individuals to Dietary Inorganic Phosphate
A study testing inorganic phosphate in people with Cardiovascular Risk Factor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
Trial summary
The study aims to compare the postprandial response of plasma phosphate and cardiometabolic relevant factors to phosphate intake in defined diet(s). Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Cardiovascular Risk Factor
- What is being tested?
- inorganic phosphate
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 29 participants
- Where
- 1 siteGermany
- Study dates
- 16 Aug 2018to 20 Jan 2020
- 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 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men and women
- age between 18 and 60 years
- informed consent
- body mass index between 18,5 up to 29,9 kg/m2
- anamnesis without diagnostic findings
Who cannot join
- Participants with epidermal growth factor receptor (eGFR) < 90 ml/min and chronic kidney disease
- Subjects suffering from vitamin D-deficiency (plasma 25(OH)D < 30 nmol/l)
- Pregnancy or lactation
- Subjects with any acute or chronic diseases (infection, tumor, cardiovascular diseases, respiratory diseases, inflammatory diseases), gastrointestinal diseases, diabetes mellitus type 1 and 2, bone diseases, diseases of the parathyroid gland
- Use of medication
- Use of dietary supplements (minerals)
Show all 11Show fewer
- Relevant food allergies (wheat protein, tomatoes)
- Weight reduction
- Smokers
- Blood donor in the last 3 months
- Participation in another intervention study
Trial locations and contacts
1 site in 1 country.
Germany1 site
Martin-Luther-University Institute of Agriculture and Nutritional Science
Halle, Saxony-Anhalt, 06120
About this study
Official title: Postprandial Response of Individuals to Dietary Inorganic Phosphate- a Randomized Trial
The study aims to compare the postprandial response of plasma phosphate and cardiometabolic relevant factors to phosphate intake in defined diet(s).
Read the detailed description
It is a monocentric, controlled intervention trial. The study will be carried out in cross-over design. This design was chosen because of a moderately strong individual metabolic response to the test meal.
Two interventions are planned in which the subjects will receive a test meal with phosphate supplement or with placebo in random order on 2 days. Subjects will be randomized to one of the 2 treatment arms.
On the two intervention days (T1 and T2), the subjects are placed a venous indwelling cannula. Immediately after the first blood sample the subjects take the fat and carbohydrate-rich test meal along with 700 mg of phosphorus or a placebo, both in the form of capsules. Phosphorus is administered as sodium phosphate . The placebo used is sodium chloride with equivalent amounts of sodium. The filler should be silica and mannitol. The capsules are made of hard gelatin and dissolve in about 10 minutes. The capsules are taken with 300 ml of water. The verum and placebo capsules are produced by the central pharmacy of the University Hospital.
The test meal consists of a pasta dish with oily tomato sauce. It is freshly prepared by the study staff and packaged airtight in individual portions before being handed out to the subjects. The test meal should be consumed within 10 - 12 minutes. The time is documented by the study staff. The next blood sample is taken immediately after the end of consumption (time 0), all other 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes thereafter. All blood samples are taken in a lying position. The first 3 hours after eating the test meal the subjects should spend reclining. In the following 5 hours subjects are free to move in the study center with each patient taking a recumbent position 10 minutes before the next blood draw. Immediately before all blood samples are taken the measurement of blood pressure and pulse is provided for which the opposite arm is to be used. Furthermore the collection of urine samples is provided every hour. Subjects are encouraged to take 200 ml of water every hour on the intervention day. At the end of the intervention, a snack will be provided.
- Conditions
- Cardiovascular Risk Factor
- Being tested
- inorganic phosphate, placebo
- Keywords
- inorganic phosphate, postprandial response, fibroblast growth factor-23, health individuals
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
inorganic phosphateDietary supplement
Sodium phosphate
placeboDietary supplement
Sodium chlorid
| Study group | Role | What they receive |
|---|---|---|
| inorganic phosphate | Experimental | Experimental intervention:
Single dose of orally administered 700 mg inorganic phosphate as sodium phosphate in combination with a standardized meal and blood sampling Receives: Dietary Supplement: inorganic phosphate |
| Placebo | Placebo comparator | Single dose of Sodium chloride in combination with a standardized meal and blood sampling Receives: Dietary Supplement: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Postprandial change of plasma phosphate concentration from baseline (0 minute) until 480 minutes
Impact of inorganic phosphate on the postprandial levels of plasma phosphate concentration
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Secondary outcomes (11)
Postprandial course of the plasma concentration of: electrolytes (calcium, sodium, potassium, magnesium)
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of the plasma concentration of: phosphate status markers (c-terminal and intact FGF23, parathormone, soluble Klotho (sKlotho), calcitriol)
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker glucose
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker insulin
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker triglycerides
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker cholesterol
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of concentration of: calcification markers dephosphorylated, noncarboxylated matrix Gla protein (dp-ucMGP), fetuin A, osteocalcin, osteoprotegerin) Inflammatory markers (hsCRP and inflammatory cytokines, especially interleukin (IL-1β)
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Activation of NLRP3-inflammasome components (ASC, caspase-1) in isolated peripheral blood monocytes (PBMC) and granulocytes under basal conditions and after stimulation
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
systolic and diastolic blood pressures
time course: measurement of blood pressure in mm Hg
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
heart rate
time course: measurement of heart rate in beats per minute
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of urine concentrations of electrolytes (phosphate, sodium, potassium, calcium, magnesium) and creatinine
Impact of inorganic phosphate on the postprandial levels
Measured: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Dec 2018
- Study start16 Aug 2018
- Primary completion25 Nov 2018
- Study completion20 Jan 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Cardiovascular Risk FactorStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- Martin-Luther-Universität Halle-Wittenberg
- Sponsor type
- University, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Responsible party
- Principal investigator, Ulf Schlegelmilch, Martin-Luther-Universität Halle-Wittenberg
- Investigators
- Gabriele Stangl, Prof.Dr., Study director, MLU, Institut für Agrar-und Ernährungswissenschaften
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03771924
- Sponsor's protocol ID
- BMBF WP2A3
- Status last verified
- May 2020
- First submitted
- 7 Nov 2018
- Last updated
- 19 May 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Nier A, Ulrich C, Volk C, Wolffgang MC, Brandsch C, Wensch-Dorendorf M, Girndt M, Stangl GI. Effects of a single phosphate-enriched test meal on inflammasome activity and postprandial inflammatory markers in healthy subjects. Eur J Nutr. 2024 Apr;63(3):797-807. doi: 10.1007/s00394-023-03306-6. Epub 2024 Jan 4.
PubMed 38175251
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Postprandial Response of Individuals to Dietary Inorganic Phosphate- a Randomized Trial
- ClinicalTrials.gov ID
- NCT03771924
- Acronym / sponsor ID
- BMBF WP2A3
- Conditions
- Cardiovascular Risk Factor
- Keywords
- inorganic phosphate, postprandial response, fibroblast growth factor-23, health individuals
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- Martin-Luther-Universität Halle-WittenbergUniversity, hospital or other
- Collaborators
- German Federal Ministry of Education and Research
- Study start
- 16 Aug 2018 (actual)
- Primary completion
- 25 Nov 2018 (actual)
- Study completion
- 20 Jan 2020 (actual)
- First posted
- 11 Dec 2018 (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.
The study aims to compare the postprandial response of plasma phosphate and cardiometabolic relevant factors to phosphate intake in defined diet(s).
Detailed description
It is a monocentric, controlled intervention trial. The study will be carried out in cross-over design. This design was chosen because of a moderately strong individual metabolic response to the test meal.
Two interventions are planned in which the subjects will receive a test meal with phosphate supplement or with placebo in random order on 2 days. Subjects will be randomized to one of the 2 treatment arms.
On the two intervention days (T1 and T2), the subjects are placed a venous indwelling cannula. Immediately after the first blood sample the subjects take the fat and carbohydrate-rich test meal along with 700 mg of phosphorus or a placebo, both in the form of capsules. Phosphorus is administered as sodium phosphate . The placebo used is sodium chloride with equivalent amounts of sodium. The filler should be silica and mannitol. The capsules are made of hard gelatin and dissolve in about 10 minutes. The capsules are taken with 300 ml of water. The verum and placebo capsules are produced by the central pharmacy of the University Hospital.
The test meal consists of a pasta dish with oily tomato sauce. It is freshly prepared by the study staff and packaged airtight in individual portions before being handed out to the subjects. The test meal should be consumed within 10 - 12 minutes. The time is documented by the study staff. The next blood sample is taken immediately after the end of consumption (time 0), all other 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes thereafter. All blood samples are taken in a lying position. The first 3 hours after eating the test meal the subjects should spend reclining. In the following 5 hours subjects are free to move in the study center with each patient taking a recumbent position 10 minutes before the next blood draw. Immediately before all blood samples are taken the measurement of blood pressure and pulse is provided for which the opposite arm is to be used. Furthermore the collection of urine samples is provided every hour. Subjects are encouraged to take 200 ml of water every hour on the intervention day. At the end of the intervention, a snack will be provided.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| inorganic phosphate | Experimental | Dietary Supplement: inorganic phosphateExperimental intervention: Single dose of orally administered 700 mg inorganic phosphate as sodium phosphate in combination with a standardized meal and blood sampling |
| Placebo | Placebo comparator | Dietary Supplement: placeboSingle dose of Sodium chloride in combination with a standardized meal and blood sampling |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- healthy men and women
- age between 18 and 60 years
- informed consent
- body mass index between 18,5 up to 29,9 kg/m2
- anamnesis without diagnostic findings
Key exclusion criteria (11 listed)
- Participants with epidermal growth factor receptor (eGFR) < 90 ml/min and chronic kidney disease
- Subjects suffering from vitamin D-deficiency (plasma 25(OH)D < 30 nmol/l)
- Pregnancy or lactation
- Subjects with any acute or chronic diseases (infection, tumor, cardiovascular diseases, respiratory diseases, inflammatory diseases), gastrointestinal diseases, diabetes mellitus type 1 and 2, bone diseases, diseases of the parathyroid gland
- Use of medication
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 |
|---|---|---|
| inorganic phosphateSodium phosphate | Dietary supplement | inorganic phosphate |
| placeboSodium chlorid | Dietary supplement | Placebo |
Primary outcome
Postprandial change of plasma phosphate concentration from baseline (0 minute) until 480 minutes
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Impact of inorganic phosphate on the postprandial levels of plasma phosphate concentration
11 secondary outcomes
Postprandial course of the plasma concentration of: electrolytes (calcium, sodium, potassium, magnesium)
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of the plasma concentration of: phosphate status markers (c-terminal and intact FGF23, parathormone, soluble Klotho (sKlotho), calcitriol)
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker glucose
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker insulin
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker triglycerides
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of plasma concentration of: cardiovascular risk marker cholesterol
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of concentration of: calcification markers dephosphorylated, noncarboxylated matrix Gla protein (dp-ucMGP), fetuin A, osteocalcin, osteoprotegerin) Inflammatory markers (hsCRP and inflammatory cytokines, especially interleukin (IL-1β)
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Activation of NLRP3-inflammasome components (ASC, caspase-1) in isolated peripheral blood monocytes (PBMC) and granulocytes under basal conditions and after stimulation
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
systolic and diastolic blood pressures
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
heart rate
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
Postprandial course of urine concentrations of electrolytes (phosphate, sodium, potassium, calcium, magnesium) and creatinine
Time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat
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 19 May 2020.
- Derived from this study: PubMed 38175251Nier A, Ulrich C, Volk C, Wolffgang MC, Brandsch C, Wensch-Dorendorf M, Girndt M, Stangl GI. Effects of a single phosphate-enriched test meal on inflammasome activity and postprandial inflammatory markers in healthy subjects. Eur J Nutr. 2024 Apr;63(3):797-807. doi: 10.1007/s00394-023-03306-6. Epub 2024 Jan 4.
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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.
Gabriele Stangl, Prof.Dr. study director
MLU, Institut für Agrar-und Ernährungswissenschaften
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing inorganic phosphate in people with Cardiovascular Risk Factor, run by Martin-Luther-Universität Halle-Wittenberg at 1 site in Germany.
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 5 inclusion and 11 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 19 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. 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. Some participants in this study may receive a placebo. 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?
Postprandial change of plasma phosphate concentration from baseline (0 minute) until 480 minutes (time frame: 0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT03771924, which also lists 1 linked publication.
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 19 May 2020.