Postprandial Response of Individuals to Dietary Inorganic Phosphate

Cardiovascular Risk Factor Clinical Trial

Official title:

Postprandial Response of Individuals to Dietary Inorganic Phosphate- a Randomized Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03771924
• Other study ID #: BMBF WP2A3
• Status: Completed
• Phase: N/A
• Start date: August 16, 2018
• Est. completion date: January 20, 2020

Study information

• Verified date: May 2020
• Source: Martin-Luther-Universität Halle-Wittenberg
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The study aims to compare the postprandial response of plasma phosphate and cardiometabolic relevant factors to phosphate intake in defined diet(s).

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 29
• Est. completion date: January 20, 2020
• Est. primary completion date: November 25, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• 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

Exclusion Criteria:

• 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)

• Relevant food allergies (wheat protein, tomatoes)

• Weight reduction

• Smokers

• Blood donor in the last 3 months

• Participation in another intervention study

Related Conditions & MeSH terms

• Cardiovascular Risk Factor

Intervention

Dietary Supplement:
• inorganic phosphate
Sodium phosphate
• placebo
Sodium chlorid

Locations

Country	Name	City	State
Germany	Martin-Luther-University Institute of Agriculture and Nutritional Science	Halle	Saxony Anhalt

Sponsors (2)

Lead Sponsor	Collaborator
Martin-Luther-Universität Halle-Wittenberg	German Federal Ministry of Education and Research

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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	Postprandial course of the plasma concentration of: electrolytes (calcium, sodium, potassium, magnesium)	Impact of inorganic phosphate on the postprandial levels	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	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	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	Postprandial course of plasma concentration of: cardiovascular risk marker glucose	Impact of inorganic phosphate on the postprandial levels	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	Postprandial course of plasma concentration of: cardiovascular risk marker insulin	Impact of inorganic phosphate on the postprandial levels	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	Postprandial course of plasma concentration of: cardiovascular risk marker triglycerides	Impact of inorganic phosphate on the postprandial levels	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	Postprandial course of plasma concentration of: cardiovascular risk marker cholesterol	Impact of inorganic phosphate on the postprandial levels	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	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-1ß)	Impact of inorganic phosphate on the postprandial levels	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	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	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	systolic and diastolic blood pressures	time course: measurement of blood pressure in mm Hg	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	heart rate	time course: measurement of heart rate in beats per minute	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	Postprandial course of urine concentrations of electrolytes (phosphate, sodium, potassium, calcium, magnesium) and creatinine	Impact of inorganic phosphate on the postprandial levels	0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat