An interventional study of inorganic phosphate and placebo in Cardiovascular Risk Factor, sponsored by Martin-Luther-Universität Halle-Wittenberg. Completed at 1 site in Germany. Open to participants aged 18 Years to 60 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2020-05-19.
Sponsored by Martin-Luther-Universität Halle-Wittenberg · Not applicable, Interventional, and Treatment
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.
Martin-Luther-Universität Halle-Wittenberg is the lead sponsor of 62 studies on the registry; 5 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Experimental intervention: Single dose of orally administered 700 mg inorganic phosphate as sodium phosphate in combination with a standardized meal and blood sampling
Dietary Supplement: inorganic phosphate
Single dose of Sodium chloride in combination with a standardized meal and blood sampling
Dietary Supplement: placebo
Sodium phosphate
Sodium chlorid
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
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: electrolytes (calcium, sodium, potassium, magnesium)
Impact of inorganic phosphate on the postprandial levels
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)
Impact of inorganic phosphate on the postprandial levels
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
Impact of inorganic phosphate on the postprandial levels
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
Impact of inorganic phosphate on the postprandial levels
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
Impact of inorganic phosphate on the postprandial levels
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
Impact of inorganic phosphate on the postprandial levels
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)
Impact of inorganic phosphate on the postprandial levels
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
Impact of inorganic phosphate on the postprandial levels
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 course: measurement of blood pressure in mm Hg
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 course: measurement of heart rate in beats per minute
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
Impact of inorganic phosphate on the postprandial levels
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
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Martin-Luther-Universität Halle-Wittenberg