<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT03771924</url>
  </required_header>
  <id_info>
    <org_study_id>BMBF WP2A3</org_study_id>
    <nct_id>NCT03771924</nct_id>
  </id_info>
  <brief_title>Postprandial Response of Individuals to Dietary Inorganic Phosphate</brief_title>
  <official_title>Postprandial Response of Individuals to Dietary Inorganic Phosphate- a Randomized Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Martin-Luther-Universität Halle-Wittenberg</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>German Federal Ministry of Education and Research</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Martin-Luther-Universität Halle-Wittenberg</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study aims to compare the postprandial response of plasma phosphate and cardiometabolic&#xD;
      relevant factors to phosphate intake in defined diet(s).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      It is a monocentric, controlled intervention trial. The study will be carried out in&#xD;
      cross-over design. This design was chosen because of a moderately strong individual metabolic&#xD;
      response to the test meal.&#xD;
&#xD;
      Two interventions are planned in which the subjects will receive a test meal with phosphate&#xD;
      supplement or with placebo in random order on 2 days. Subjects will be randomized to one of&#xD;
      the 2 treatment arms.&#xD;
&#xD;
      On the two intervention days (T1 and T2), the subjects are placed a venous indwelling&#xD;
      cannula. Immediately after the first blood sample the subjects take the fat and&#xD;
      carbohydrate-rich test meal along with 700 mg of phosphorus or a placebo, both in the form of&#xD;
      capsules. Phosphorus is administered as sodium phosphate . The placebo used is sodium&#xD;
      chloride with equivalent amounts of sodium. The filler should be silica and mannitol. The&#xD;
      capsules are made of hard gelatin and dissolve in about 10 minutes. The capsules are taken&#xD;
      with 300 ml of water. The verum and placebo capsules are produced by the central pharmacy of&#xD;
      the University Hospital.&#xD;
&#xD;
      The test meal consists of a pasta dish with oily tomato sauce. It is freshly prepared by the&#xD;
      study staff and packaged airtight in individual portions before being handed out to the&#xD;
      subjects. The test meal should be consumed within 10 - 12 minutes. The time is documented by&#xD;
      the study staff. The next blood sample is taken immediately after the end of consumption&#xD;
      (time 0), all other 15, 30, 45, 60, 90, 120, 180, 240, 300, 360, 420 and 480 minutes&#xD;
      thereafter. All blood samples are taken in a lying position. The first 3 hours after eating&#xD;
      the test meal the subjects should spend reclining. In the following 5 hours subjects are free&#xD;
      to move in the study center with each patient taking a recumbent position 10 minutes before&#xD;
      the next blood draw. Immediately before all blood samples are taken the measurement of blood&#xD;
      pressure and pulse is provided for which the opposite arm is to be used. Furthermore the&#xD;
      collection of urine samples is provided every hour. Subjects are encouraged to take 200 ml of&#xD;
      water every hour on the intervention day. At the end of the intervention, a snack will be&#xD;
      provided.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 16, 2018</start_date>
  <completion_date type="Actual">January 20, 2020</completion_date>
  <primary_completion_date type="Actual">November 25, 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Crossover Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postprandial change of plasma phosphate concentration from baseline (0 minute) until 480 minutes</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels of plasma phosphate concentration</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of the plasma concentration of: electrolytes (calcium, sodium, potassium, magnesium)</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of the plasma concentration of: phosphate status markers (c-terminal and intact FGF23, parathormone, soluble Klotho (sKlotho), calcitriol)</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of plasma concentration of: cardiovascular risk marker glucose</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of plasma concentration of: cardiovascular risk marker insulin</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of plasma concentration of: cardiovascular risk marker triglycerides</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of plasma concentration of: cardiovascular risk marker cholesterol</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>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)</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Activation of NLRP3-inflammasome components (ASC, caspase-1) in isolated peripheral blood monocytes (PBMC) and granulocytes under basal conditions and after stimulation</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>systolic and diastolic blood pressures</measure>
    <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</time_frame>
    <description>time course: measurement of blood pressure in mm Hg</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>heart rate</measure>
    <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</time_frame>
    <description>time course: measurement of heart rate in beats per minute</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Postprandial course of urine concentrations of electrolytes (phosphate, sodium, potassium, calcium, magnesium) and creatinine</measure>
    <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</time_frame>
    <description>Impact of inorganic phosphate on the postprandial levels</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">29</enrollment>
  <condition>Cardiovascular Risk Factor</condition>
  <arm_group>
    <arm_group_label>inorganic phosphate</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Experimental intervention:&#xD;
Single dose of orally administered 700 mg inorganic phosphate as sodium phosphate in combination with a standardized meal and blood sampling</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Placebo</arm_group_label>
    <arm_group_type>Placebo Comparator</arm_group_type>
    <description>Single dose of Sodium chloride in combination with a standardized meal and blood sampling</description>
  </arm_group>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>inorganic phosphate</intervention_name>
    <description>Sodium phosphate</description>
    <arm_group_label>inorganic phosphate</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Dietary Supplement</intervention_type>
    <intervention_name>placebo</intervention_name>
    <description>Sodium chlorid</description>
    <arm_group_label>Placebo</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  healthy men and women&#xD;
&#xD;
          -  age between 18 and 60 years&#xD;
&#xD;
          -  informed consent&#xD;
&#xD;
          -  body mass index between 18,5 up to 29,9 kg/m2&#xD;
&#xD;
          -  anamnesis without diagnostic findings&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Participants with epidermal growth factor receptor (eGFR) &lt; 90 ml/min and chronic&#xD;
             kidney disease&#xD;
&#xD;
          -  Subjects suffering from vitamin D-deficiency (plasma 25(OH)D &lt; 30 nmol/l)&#xD;
&#xD;
          -  Pregnancy or lactation&#xD;
&#xD;
          -  Subjects with any acute or chronic diseases (infection, tumor, cardiovascular&#xD;
             diseases, respiratory diseases, inflammatory diseases), gastrointestinal diseases,&#xD;
             diabetes mellitus type 1 and 2, bone diseases, diseases of the parathyroid gland&#xD;
&#xD;
          -  Use of medication&#xD;
&#xD;
          -  Use of dietary supplements (minerals)&#xD;
&#xD;
          -  Relevant food allergies (wheat protein, tomatoes)&#xD;
&#xD;
          -  Weight reduction&#xD;
&#xD;
          -  Smokers&#xD;
&#xD;
          -  Blood donor in the last 3 months&#xD;
&#xD;
          -  Participation in another intervention study&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Gabriele Stangl, Prof.Dr.</last_name>
    <role>Study Director</role>
    <affiliation>MLU, Institut für Agrar-und Ernährungswissenschaften</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Martin-Luther-University Institute of Agriculture and Nutritional Science</name>
      <address>
        <city>Halle</city>
        <state>Saxony Anhalt</state>
        <zip>06120</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <verification_date>May 2020</verification_date>
  <study_first_submitted>November 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>May 18, 2020</last_update_submitted>
  <last_update_submitted_qc>May 18, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">May 19, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Martin-Luther-Universität Halle-Wittenberg</investigator_affiliation>
    <investigator_full_name>Ulf Schlegelmilch</investigator_full_name>
    <investigator_title>Study Coordinator</investigator_title>
  </responsible_party>
  <keyword>inorganic phosphate</keyword>
  <keyword>postprandial response</keyword>
  <keyword>fibroblast growth factor-23</keyword>
  <keyword>health individuals</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT03771924
org study id: BMBF WP2A3
nct id: NCT03771924
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The study aims to compare the postprandial response of plasma phosphate and cardiometabolic
      relevant factors to phosphate intake in defined diet(s).
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.
allocation: Randomized
intervention model: Crossover Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
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
description: Impact of inorganic phosphate on the postprandial levels of plasma phosphate concentration
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
measure: 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
description: time course: measurement of blood pressure in mm Hg
measure: 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
description: time course: measurement of heart rate in beats per minute
measure: 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
description: Impact of inorganic phosphate on the postprandial levels
arm group label: inorganic phosphate
arm group type: Experimental
description: Experimental intervention:
Single dose of orally administered 700 mg inorganic phosphate as sodium phosphate in combination with a standardized meal and blood sampling
arm group label: Placebo
arm group type: Placebo Comparator
description: Single dose of Sodium chloride in combination with a standardized meal and blood sampling
intervention type: Dietary Supplement
intervention name: inorganic phosphate
description: Sodium phosphate
arm group label: inorganic phosphate
intervention type: Dietary Supplement
intervention name: placebo
description: Sodium chlorid
arm group label: Placebo
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Gabriele Stangl, Prof.Dr.
role: Study Director
affiliation: MLU, Institut für Agrar-und Ernährungswissenschaften
facility: 
country: Germany
responsible party type: Principal Investigator
investigator affiliation: Martin-Luther-Universität Halle-Wittenberg
investigator full name: Ulf Schlegelmilch
investigator title: Study Coordinator