Fat ExcretionKIFU/B266NCT01542164
Calcium Intake and Fat Excretion
An observational study of Fat Excretion and Energy Excretion, run by University of Copenhagen at 1 site in Denmark.
Trial summary
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion. Read more about this study
- Who is it for?
- Ages 18 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Fat Excretion, Energy Excretion
- How many people
- 158 participants
- Where
- 1 siteDenmark
- Study dates
- Jun 2010to Aug 2011
- Phase
- Observational
- 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 18 to 50 years
- All sexes
- Healthy volunteers accepted
- Adult
Study population: Residents of Copenhagen and Sjælland
Who may be able to join
- age between 18 - 50 years
- healthy
- weight stable within 4 months prior to the inclusion
Who cannot join
- pregnant or lactating
- uses cholesterol lowering drugs
- on diet
- suffering from, now or previously, any gastrointestinal diseases
- elite athletes
- participation in other concomitant trial
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Dept. of Human Nutrition, Faculty of Life Sciences, University of Copenhagen
Frederiksberg, Copenhagen, 1958
About this study
Official title: Calcium Intake and Fat Excretion - an Observational Study
The overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.
Read the detailed description
Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.
The aim of this study is to examined for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight
- Conditions
- Fat Excretion, Energy Excretion
- Keywords
- Calcium intake, Fat excretion, Energy excretion, Gut micro flora
What is being measured
The primary outcome is the main question the study is designed to answer.
Total fat and energy excretion
Total fat and energy excretion in faeces during the test period of 5 consecutive days
Measured: 5 days
Secondary outcomes (8)
p-vitamin D
Measured: 1 day
p-PTH
Parathyroid hormone (PTH)
Measured: 1 day
Selected genetic variations
DNA from blood sample
Measured: 1 day
Blood lipids and cholesterol
Total p-cholesterol, p-LDL, p-HDL, p-TG and p-FFA
Measured: 1 day
calcium excretion
Total calcium excretion in faeces and urin during the test period of 2 consecutive days
Measured: 2 days
Gut micro flora
Identification of gut micro flora
Measured: 1 day
NMR-spectroscopy based metabonomics profiling of urin
NMR-spectroscopy based metabonomics profiling of each test subject
Measured: 1 day
blood pressure
Resting blood pressure
Measured: 1 day
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Mar 2012 (estimated)
- Study startJun 2010
- Primary completionAug 2011
- Study completionAug 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Fat ExcretionStudies 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
- Observational
- Observational model
- Other
- Time perspective
- Cross-sectional
- Enrolment
- 158 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Arla Foods, The Danish Dairy Research Foundation, Denmark
- Responsible party
- Principal investigator, Arne Astrup, University of Copenhagen
- Investigators
- Lesli H. Larsen, Ass. Prof., Principal investigator, Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01542164
- Sponsor's protocol ID
- H-B-2009-071
- Acronym
- KIFU/B266
- Status last verified
- Feb 2017
- First submitted
- 26 May 2010
- Last updated
- 7 Feb 2017
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 Feb 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Calcium Intake and Fat Excretion - an Observational Study
- ClinicalTrials.gov ID
- NCT01542164
- Acronym / sponsor ID
- KIFU/B266 / H-B-2009-071
- Conditions
- Fat Excretion, Energy Excretion
- Keywords
- Calcium intake, Fat excretion, Energy excretion, Gut micro flora
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 158 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- The Ministry of Science, Technology and Innovation, Denmark, Arla Foods, The Danish Dairy Research Foundation, Denmark
- Study start
- Jun 2010 (actual)
- Primary completion
- Aug 2011 (actual)
- Study completion
- Aug 2011 (actual)
- First posted
- 2 Mar 2012 (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 overall purpose of this study is to examine the effect of calcium on fecal fat and energy excretion.
Detailed description
Several reports have found inverse associations between calcium intake and body weight. Few intervention studies have shown that a high calcium diet resulted in a greater body weight loss than a low calcium diet. The mechanism is not clear, but one possible explanation is reduced absorption of fat in the gut, due to formation of insoluble calcium fatty acid soaps or binding of bile acids which impairs the formation of micelles.
The aim of this study is to examined for an association between habitual calcium intake and fecal energy and fat excretion, concentrations of substrates involved in energy metabolism, blood pressure and body weight
Study design
- Observational model
- Other
- Time perspective
- Cross-sectional
Who may qualify
- Ages
- 18 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Residents of Copenhagen and Sjælland
Key inclusion criteria (3 listed)
- age between 18 - 50 years
- healthy
- weight stable within 4 months prior to the inclusion
Key exclusion criteria (6 listed)
- pregnant or lactating
- uses cholesterol lowering drugs
- on diet
- suffering from, now or previously, any gastrointestinal diseases
- elite athletes
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Total fat and energy excretion
Time frame: 5 days
Total fat and energy excretion in faeces during the test period of 5 consecutive days
8 secondary outcomes
p-vitamin D
Time frame: 1 day
p-PTH
Time frame: 1 day
Selected genetic variations
Time frame: 1 day
Blood lipids and cholesterol
Time frame: 1 day
calcium excretion
Time frame: 2 days
Gut micro flora
Time frame: 1 day
NMR-spectroscopy based metabonomics profiling of urin
Time frame: 1 day
blood pressure
Time frame: 1 day
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 Feb 2017.
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.
Lesli H. Larsen, Ass. Prof. principal investigator
Dept. of Human Nutrition, Faculty of Life Sciences, Univerity of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Fat Excretion and Energy Excretion, run by University of Copenhagen at 1 site in Denmark.
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 3 inclusion and 6 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 Feb 2017. 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 Denmark. 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. 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?
Total fat and energy excretion (time frame: 5 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 Feb 2017.