Effects of Soluble Phosphate in Humans

NCT ID: NCT02095392

Last Updated: 2015-12-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

62 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-04-30

Study Completion Date

2014-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Volunteers

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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P1000/Ca0

Group Type EXPERIMENTAL

P1000/Ca0

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

P1000/Ca500

Group Type EXPERIMENTAL

P1000/Ca500

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

P1000/Ca1000

Group Type EXPERIMENTAL

P1000/Ca1000

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Intervention Type DIETARY_SUPPLEMENT

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

Placebo

Group Type PLACEBO_COMPARATOR

P1000/Ca0

Intervention Type DIETARY_SUPPLEMENT

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

P1000/Ca500

Intervention Type DIETARY_SUPPLEMENT

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

P1000/Ca1000

Intervention Type DIETARY_SUPPLEMENT

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

Interventions

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P1000/Ca0

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

Intervention Type DIETARY_SUPPLEMENT

P1000/Ca500

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

Intervention Type DIETARY_SUPPLEMENT

P1000/Ca1000

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

Intervention Type DIETARY_SUPPLEMENT

Placebo

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

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* age between 18-60 years
* physical health

Exclusion Criteria

* postmenopausal women
* kidney diseases
* diabetes mellitus
* metabolic diseases
* osteoporosis
* intake of dietary supplements
* pregnancy and lactation
Minimum Eligible Age

18 Years

Maximum Eligible Age

60 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Jena

OTHER

Sponsor Role lead

Responsible Party

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Prof. Dr. Michael Glei

Prof. Dr.

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Michael Glei, Prof. Dr.

Role: PRINCIPAL_INVESTIGATOR

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

Locations

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

Jena, Thuringia, Germany

Site Status

Countries

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Germany

References

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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.

Reference Type DERIVED
PMID: 29452584 (View on PubMed)

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.

Reference Type DERIVED
PMID: 26786148 (View on PubMed)

Other Identifiers

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H55-14

Identifier Type: -

Identifier Source: org_study_id