NCT03771924

Brief Summary

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Aug 2018

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 16, 2018

Completed
3 months until next milestone

First Submitted

Initial submission to the registry

November 7, 2018

Completed
18 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2018

Completed
16 days until next milestone

First Posted

Study publicly available on registry

December 11, 2018

Completed
1.1 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 20, 2020

Completed
Last Updated

May 19, 2020

Status Verified

May 1, 2020

Enrollment Period

3 months

First QC Date

November 7, 2018

Last Update Submit

May 18, 2020

Conditions

Cardiovascular Risk Factor

Keywords

inorganic phosphatepostprandial responsefibroblast growth factor-23health individuals

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (11)

  • Postprandial course of the plasma concentration of: electrolytes (calcium, sodium, potassium, magnesium)

    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)

    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

    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

    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

    0,15,30,45,60,90,120,180,240,300, 360, 420 and 480 minutes after ingestion of testmeal rich in carbohydrates and fat

  • +6 more secondary outcomes

Study Arms (2)

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

Dietary Supplement: inorganic phosphate

Placebo

PLACEBO COMPARATOR

Single dose of Sodium chloride in combination with a standardized meal and blood sampling

Dietary Supplement: placebo

Interventions

inorganic phosphateDIETARY_SUPPLEMENT

Sodium phosphate

inorganic phosphate
placeboDIETARY_SUPPLEMENT

Sodium chlorid

Placebo

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Martin-Luther-University Institute of Agriculture and Nutritional Science

Halle, Saxony-Anhalt, 06120, Germany

Location

Related Publications (1)

  • 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.

    PMID: 38175251DERIVED

MeSH Terms

Interventions

Phosphates

Intervention Hierarchy (Ancestors)

Phosphoric AcidsPhosphorus AcidsAcids, NoncarboxylicAcidsInorganic ChemicalsAnionsIonsElectrolytesPhosphorus Compounds

Study Officials

  • Gabriele Stangl, Prof.Dr.

    MLU, Institut für Agrar-und Ernährungswissenschaften

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Study Coordinator

Study Record Dates

First Submitted

November 7, 2018

First Posted

December 11, 2018

Study Start

August 16, 2018

Primary Completion

November 25, 2018

Study Completion

January 20, 2020

Last Updated

May 19, 2020

Record last verified: 2020-05

Locations

DE(1)