Healthy MenNCT01296997
Calcium Phosphate and Incretins
A study testing calcium phosphate in people with Healthy Men, run by University of Jena at 1 site in Germany.
Trial summary
The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins. Read more about this study
- Who is it for?
- Ages 20 to 35 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Healthy Men
- What is being tested?
- calcium phosphate
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 10 participants
- Where
- 1 siteGermany
- Study dates
- Jul 2010to Sep 2010
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 20 to 35 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- healthy men
Who cannot join
- intake of dietary supplements and chronic diseases
Trial locations and contacts
1 site in 1 country.
Germany1 site
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
Jena, Thuringia, 07743
About this study
Official title: Influence of a Calcium Phosphate Supplementation on the Secretion of Incretins in Humans.
The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins.
- Conditions
- Healthy Men
- Being tested
- calcium phosphate, placebo
- Keywords
- calcium phosphate, incretins, human study
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
calcium phosphateDietary supplement
the subjects consumed for 3 weeks a bread enriched with 1 g pentacalcium phosphate per day
placeboOther
the subjects consumed a bread without pentacalcium phosphate
| Study group | Role | What they receive |
|---|---|---|
| calcium phosphate | Experimental | Not described Receives: Dietary Supplement: calcium phosphate |
| placebo | Placebo comparator | Not described Receives: Other: placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
secretion of incretins
Measured: 3 weeks
Secondary outcomes (1)
concentration of minerals in plasma
Measured: 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Feb 2011 (estimated)
- Study startJul 2010
- Primary completionSep 2010
- Study completionSep 2010
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Healthy MenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 10 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Jena
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Gerhard Jahreis, University of Jena
- Investigators
- Gerhard Jahreis, Prof. Dr., Principal investigator, Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01296997
- Sponsor's protocol ID
- LSEP H45-10
- Status last verified
- Nov 2012
- First submitted
- 15 Feb 2011
- Last updated
- 7 Nov 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 23510513
Study at a glance
From the registry record, last updated by the sponsor on 7 Nov 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Influence of a Calcium Phosphate Supplementation on the Secretion of Incretins in Humans.
- ClinicalTrials.gov ID
- NCT01296997
- Acronym / sponsor ID
- LSEP H45-10
- Conditions
- Healthy Men
- Keywords
- calcium phosphate, incretins, human study
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 10 participants (actual)
- Lead sponsor
- University of JenaUniversity, hospital or other
- Study start
- Jul 2010
- Primary completion
- Sep 2010 (actual)
- Study completion
- Sep 2010 (actual)
- First posted
- 16 Feb 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study was conducted to investigate the effect of a calcium phosphate supplementation on the secretion of incretins.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| calcium phosphate | Experimental | Dietary Supplement: calcium phosphate |
| placebo | Placebo comparator | Other: placebo |
Who may qualify
- Ages
- 20 to 35 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- healthy men
Key exclusion criteria (1 listed)
- intake of dietary supplements and chronic diseases
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| calcium phosphatethe subjects consumed for 3 weeks a bread enriched with 1 g pentacalcium phosphate per day | Dietary supplement | calcium phosphate |
| placebothe subjects consumed a bread without pentacalcium phosphate | Other | placebo |
Primary outcome
secretion of incretins
Time frame: 3 weeks
1 secondary outcome
concentration of minerals in plasma
Time frame: 3 weeks
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2012.
- Derived from this study: PubMed 23510513Trautvetter 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.
Related trials for Healthy Men
Active, not recruitingPhase 1
A Study to Compare How 2 Different Formulations of Survodutide Are Taken up in the Body When Given by Injection in Healthy Men and Women With and Without Overweight or Obesity
Healthy, Obesity
RecruitingPhase 1
A Study in Healthy Men to Test How Well Different Doses of BI 3776528 Are Tolerated
Healthy
Not yet recruitingPhase 4
Study to Evaluate the Effect of Zoliflodacin on Testicular Function in Healthy Adult Men
Testicular Abnominalies
Not yet recruiting
Effects of Tart Cherry and Aronia Extract Supplementation on Selected Physiological Parameters in Endurance-Trained Men
Cardiovascular Physiology
Active, not recruitingPhase 1
Evaluate the Pharmacokinetics, Pharmacodynamics, Safety and Tolerability of BGM1812 Injection Following Single and Multiple Subcutaneous Administration in Normal to Overweight or Obese But Otherwise Healthy Men and Women
Healhty, Overweight or Obesity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Gerhard Jahreis, Prof. Dr. principal investigator
Friedrich-Schiller-University Jena, Institute of Nutrition, Department of Nutritional Physiology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing calcium phosphate in people with Healthy Men, run by University of Jena at 1 site in Germany.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
secretion of incretins (time frame: 3 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01296997, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2012.