NCT02095392

Brief Summary

The study was conducted to investigate the effect of soluble phosphate in combination with different calcium doses on calcium and phosphorus metabolism and further physiological parameters in healthy subjects. The main aim of the study is to investigate the influence of a soluble phosphate supplementation on the fasting blood phosphate concentration and the dependency of an additional calcium intake.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
62

participants targeted

Target at P50-P75 for not_applicable healthy-volunteers

Timeline
Completed

Started Apr 2014

Shorter than P25 for not_applicable healthy-volunteers

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

First Submitted

Initial submission to the registry

March 17, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 24, 2014

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2014

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

July 1, 2014

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2014

Completed
Last Updated

December 2, 2015

Status Verified

November 1, 2015

Enrollment Period

3 months

First QC Date

March 17, 2014

Last Update Submit

November 30, 2015

Conditions

Healthy Volunteers

Keywords

soluble phosphatephosphorus metabolismcalcium metabolismbone metabolismhuman study

Outcome Measures

Primary Outcomes (1)

  • Fasting phosphate concentration in blood

    8 weeks

Secondary Outcomes (1)

  • Calcium and phosphorus metabolism

    8 weeks

Study Arms (4)

P1000/Ca0

EXPERIMENTAL
Dietary Supplement: P1000/Ca0Dietary Supplement: Placebo

P1000/Ca500

EXPERIMENTAL
Dietary Supplement: P1000/Ca500Dietary Supplement: Placebo

P1000/Ca1000

EXPERIMENTAL
Dietary Supplement: P1000/Ca1000Dietary Supplement: Placebo

Placebo

PLACEBO COMPARATOR
Dietary Supplement: P1000/Ca0Dietary Supplement: P1000/Ca500Dietary Supplement: P1000/Ca1000

Interventions

P1000/Ca0DIETARY_SUPPLEMENT

22 subjects consume for 8 weeks a beverage enriched with phosphate \[1g phosphorus/d\]

P1000/Ca0Placebo
P1000/Ca500DIETARY_SUPPLEMENT

22 subjects consume for 8 weeks a beverage enriched with phosphate \[1 g phosphorus/d\] and calcium \[0,5 g calcium\]

P1000/Ca500Placebo
P1000/Ca1000DIETARY_SUPPLEMENT

22 subjects consume for 8 weeks a beverage enriched with phosphate \[1 g phosphorus/d\] and calcium \[1 g calcium\]

P1000/Ca1000Placebo
PlaceboDIETARY_SUPPLEMENT

all participants consume two weeks before intervention the beverage without phosphate and calcium

P1000/Ca0P1000/Ca1000P1000/Ca500

Eligibility Criteria

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

You may qualify if:

  • age between 18-60 years
  • physical health

You may not qualify if:

  • postmenopausal women
  • kidney diseases
  • diabetes mellitus
  • metabolic diseases
  • osteoporosis
  • intake of dietary supplements
  • pregnancy and lactation

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology

Jena, Thuringia, 07743, Germany

Location

Related Publications (2)

  • Trautvetter U, Camarinha-Silva A, Jahreis G, Lorkowski S, Glei M. High phosphorus intake and gut-related parameters - results of a randomized placebo-controlled human intervention study. Nutr J. 2018 Feb 16;17(1):23. doi: 10.1186/s12937-018-0331-4.

    PMID: 29452584DERIVED

  • Trautvetter U, Jahreis G, Kiehntopf M, Glei M. Consequences of a high phosphorus intake on mineral metabolism and bone remodeling in dependence of calcium intake in healthy subjects - a randomized placebo-controlled human intervention study. Nutr J. 2016 Jan 19;15:7. doi: 10.1186/s12937-016-0125-5.

    PMID: 26786148DERIVED

MeSH Terms

Interventions

Flavonoids

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-Ring

Study Officials

  • Michael Glei, Prof. Dr.

    Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Toxicology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr.

Study Record Dates

First Submitted

March 17, 2014

First Posted

March 24, 2014

Study Start

April 1, 2014

Primary Completion

July 1, 2014

Study Completion

July 1, 2014

Last Updated

December 2, 2015

Record last verified: 2015-11

Locations

DE(1)