Postprandial Response of Individuals to Dietary Inorganic Phosphate

Status Completed

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).

Clinical Trial 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

Related Conditions & MeSH terms

Cardiovascular Risk Factor

Clinical Trial Details

NCT number	NCT03771924
Study type	Interventional
Source	Martin-Luther-Universität Halle-Wittenberg
Contact
Status	Completed
Phase	N/A
Start date	August 16, 2018
Completion date	January 20, 2020

View Details

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Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.

Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.