NCT01296997

Brief Summary

The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
10

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2010

Shorter than P25 for not_applicable

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

July 1, 2010

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2010

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2010

Completed
6 months until next milestone

First Submitted

Initial submission to the registry

February 15, 2011

Completed
1 day until next milestone

First Posted

Study publicly available on registry

February 16, 2011

Completed
Last Updated

November 7, 2012

Status Verified

November 1, 2012

Enrollment Period

2 months

First QC Date

February 15, 2011

Last Update Submit

November 6, 2012

Conditions

Healthy Men

Keywords

calcium phosphateincretinshuman study

Outcome Measures

Primary Outcomes (1)

  • secretion of incretins

    3 weeks

Secondary Outcomes (1)

  • concentration of minerals in plasma

    3 weeks

Study Arms (2)

calcium phosphate

EXPERIMENTAL
Dietary Supplement: calcium phosphate

placebo

PLACEBO COMPARATOR
Other: placebo

Interventions

calcium phosphateDIETARY_SUPPLEMENT

the subjects consumed for 3 weeks a bread enriched with 1 g pentacalcium phosphate per day

calcium phosphate
placeboOTHER

the subjects consumed a bread without pentacalcium phosphate

placebo

Eligibility Criteria

Age20 Years - 35 Years
Sexmale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • healthy men

You may not qualify if:

  • intake of dietary supplements and chronic diseases

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

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

Jena, Thuringia, 07743, Germany

Location

Related Publications (1)

  • Trautvetter U, Kiehntopf M, Jahreis G. Postprandial effects of calcium phosphate supplementation on plasma concentration-double-blind, placebo-controlled cross-over human study. Nutr J. 2013 Mar 8;12:30. doi: 10.1186/1475-2891-12-30.

    PMID: 23510513DERIVED

MeSH Terms

Interventions

calcium phosphate

Study Officials

  • Gerhard Jahreis, Prof. Dr.

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
QUADRUPLE
Who Masked
PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Prof. Dr. habil

Study Record Dates

First Submitted

February 15, 2011

First Posted

February 16, 2011

Study Start

July 1, 2010

Primary Completion

September 1, 2010

Study Completion

September 1, 2010

Last Updated

November 7, 2012

Record last verified: 2012-11

Locations

DE(1)